- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01474746
Trial of Sertraline to Treat Children With Fragile X Syndrome
A Controlled Trial of Sertraline in Young Children With Fragile X Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single center study and the UC Davis MIND Institute for fragile X syndrome (FXS) patients aged between 2 years and 5 years, 8 months old funded by the Health Resources and Services Administration (HRSA). It is a double-blind control trial of sertraline (Zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are investigating the use of this selective serotonin reuptake inhibitor (SSRI) in FXS because a retrospective study has shown significant improvements in language and decreases in autistic behavior. There is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development of animal models of Down syndrome. The researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors.
The aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with FXS who are between the ages of 2 years and 5 years, 8 months old. At baseline, the researchers will assess behavioral and cognitive development. These children will be treated for six months with either sertraline or placebo. At the end of the six months, the researchers assess the same behavioral and cognitive measures as at the beginning of the study. The researchers will also assess the side effects of the sertraline treatment throughout the study.
On March 14, 2017 two secondary outcomes for each of the primary outcomes were added for clarification of measurements at baseline visit and at six-month visit. In April 2017 additional updates were made to report primary and secondary outcome results. By June 2, 2017 all outstanding secondary outcome results had been added.
In July 2017, additional updates to the outcome measures and limitations sections were made to address PRS review comments. In the process of responding to these comments, a duplicate reported outcome measure was identified and deleted.
In August 2017, additional updates to the outcome measures were made to address PRS review comments issued in response to the July 2017 updates.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- UC Davis M.I.N.D. Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fragile X Syndrome
Exclusion Criteria:
- Current or past SSRI treatment
- Current or past MAOI (monoamine oxidase inhibitor ) treatment
- Serious co-morbid medical disorder affecting brain function and behavior (not including fragile X syndrome).
- Uncontrolled seizure disorder or epilepsy
- Bipolar disorder
- Latex allergies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline.
This group will be placed on a placebo.
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The placebo will be dosed in an age-dependent manner.
Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months.
Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.
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Experimental: Active
This arm will undergo identical treatment and assessments as the placebo group.
This group will receive the active agent, sertraline.
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Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner.
Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months.
Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mullen Scales of Early Learning - Expressive Language Raw Score
Time Frame: From baseline visit to six-month visit.
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale.
This scale's raw scores range from 0 to 50.
The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability.
The MSEL was administered at the baseline visit and at the 6-month follow-up visit.
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From baseline visit to six-month visit.
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Clinical Global Impression - Improvement
Time Frame: 6-month follow-up visit score
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The Clinical Global Impression - Improvement (CGI-I) is used to measure the overall behavioral change of an individual and their therapeutic response.
The CGI-I is a 3-item observer-rated scale administered by the physician to the caregiver, who assesses improvement using a 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse.
Therefore, the lower the score, the greater the behavioral improvement as rated by the caregiver.
Shown here are the CGI-I mean scores from the 6-month follow-up visit.
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6-month follow-up visit score
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Change in Mullen Scales of Early Learning - Expressive Language Standard T Score
Time Frame: From baseline visit to six-month visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language.
Based on the raw score obtained by the participant in each scale the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately.
Shown here are the baseline and 6-month follow-up T scores from the expressive language scale.
T scores have a range of 20 to 80, a mean of 50, and a standard deviation of 10.
Any child scoring at or below 1.5 standard deviations below the average is considered presenting significant delays.
The lower the T score, the worse the outcome.
The MSEL was administered at the baseline visit and at the 6-month follow-up visit.
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From baseline visit to six-month visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autism Diagnostic Observation Schedule
Time Frame: At baseline visit
|
The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder.
This test was administered at baseline and at the six-month follow-up visit.
The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent.
The scoring algorithm gives an overall total, which ranges from 0 to 28.
The higher the score, the higher the level of autism-related symptoms.
The overall total ranges from 0 to 28.
On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above.
On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.
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At baseline visit
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Visual Analog Scale
Time Frame: At baseline visit
|
The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s).
Parents mark on a visual line measuring 10 cm with "worst behavior" at 0 cm and "best behavior" at 10 cm.
The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication.
For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit.
The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much.
Shown here is the mean distance in cm from the "worst behavior" side, at baseline.
The smaller the value, the worse the behavior.
The range is minimum 0 cm to maximum 10 cm.
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At baseline visit
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Eye Tracking
Time Frame: At baseline visit
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There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention.
All stimuli are presented on a Tobii T120 binocular eye tracker monitor.
The system consists of a high-resolution camera embedded in a 17-inch TFT monitor.
Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images.
Shown here are the averaged response times (in seconds) to the presented stimuli, at the baseline visit.
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At baseline visit
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Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score
Time Frame: At baseline visit
|
The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months.
The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills.
The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills.
The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL).
Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores).
The higher the scores, the greater the language ability.
Shown here are the mean TL raw scores from the baseline visit.
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At baseline visit
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Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score
Time Frame: At baseline visit
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The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old.
The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning).
Reported here is the Social Participation subscale mean raw score, which ranges from 8 to 32.
The lower the raw score, the more limited the child's level of social participation.
The higher the score, the greater the child's level of social participation.
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At baseline visit
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Sensory Profile - Sensation Seeking Subscale Raw Score
Time Frame: At baseline visit
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The Sensory Profile is designed to measure sensory-related difficulties.
This measure will be administered to the primary caregiver of each subject to measure the caregiver's sensory ability and its impact on the subject.
Of the four subscales scored in the Sensory Profile, the "Sensation Seeking" subscale mean raw scores for the placebo and treatment groups are reported here.
This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others.
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At baseline visit
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Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score
Time Frame: At baseline visit
|
The Vineland-II measures the personal and social skills of individuals from birth through adulthood.
It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages.
The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills.
Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables.
Reported here are the ABC mean standard scores for the placebo and treatment groups baseline.
The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.
|
At baseline visit
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Mullen Scales of Early Learning - Visual Reception Raw Score
Time Frame: At baseline visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the mean baseline raw scores from the Visual Reception scale.
This scale's raw scores range from 0 to 50.
The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.
|
At baseline visit
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Mullen Scales of Early Learning - Fine Motor Raw Score
Time Frame: At baseline visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the mean raw scores from the Fine Motor scale at the baseline visit.
This scale's raw scores range from 0 to 49.
The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.
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At baseline visit
|
The Autism Diagnostic Observation Schedule (ADOS-2)
Time Frame: At six month visit
|
The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder.
This test was administered at baseline and at the six-month follow-up visit.
The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent.
The scoring algorithm gives an overall total, which ranges from 0 to 28.
The higher the score, the higher the level of autism-related symptoms.
The overall total ranges from 0 to 28.
On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above.
On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.
|
At six month visit
|
The Visual Analog Scale
Time Frame: At six-month visit
|
The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s).
Parents mark on a visual line measuring 10 cm with "worst behavior" at 0 cm and "best behavior" at 10 cm.
The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication.
For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit.
The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much.
Shown here is the mean distance in cm from the "worst behavior" side, at the 6-month visit.
The smaller the value, the worse the behavior.
The range is minimum 0 cm to maximum 10 cm.
|
At six-month visit
|
Eye Tracking
Time Frame: At six-month visit
|
There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention.
All stimuli are presented on a Tobii T120 binocular eye tracker monitor.
The system consists of a high-resolution camera embedded in a 17-inch TFT monitor.
Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images.
Shown here are the averaged response times (in seconds) to the presented stimuli, at the 6-month follow-up visit.
|
At six-month visit
|
Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score
Time Frame: At six-month visit
|
The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months.
The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills.
The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills.
The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL).
Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores).
The higher the scores, the greater the language ability.
Shown here are the mean TL raw scores from the 6-month follow-up visit.
|
At six-month visit
|
Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score
Time Frame: At six-month visit
|
The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old.
The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning).
The SPM-P was administered to the caregiver at baseline and again at the 6-month follow-up visit.
Reported here is the Social Participation subscale mean raw score from the 6-month visit, which ranges from 8 to 32.
The lower the raw score, the more limited the child's level of social participation.
The higher the score, the greater the child's level of social participation.
|
At six-month visit
|
Sensory Profile - Sensation Seeking Subscale Raw Score
Time Frame: At six-month visit
|
The Sensory Profile is designed to measure sensory-related difficulties.
This measure will be administered to the primary caregiver of each subject to measure the caregiver's sensory ability and its impact on the subject.
Of the four subscales scored in the Sensory Profile, the "Sensation Seeking" subscale mean raw scores for the placebo and treatment groups are reported here.
This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others.
|
At six-month visit
|
Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score
Time Frame: At six-month visit
|
The Vineland-II measures the personal and social skills of individuals from birth through adulthood.
It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages.
The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills.
Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables.
Reported here are the ABC mean standard scores for the placebo and treatment groups at the 6-month visit.
The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.
|
At six-month visit
|
Mullen Scales of Early Learning - Visual Reception Raw Score
Time Frame: At six-month visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the mean raw scores from the Visual Reception scale at the 6-month follow-up visit.
This scale's raw scores range from 0 to 50.
The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.
|
At six-month visit
|
Mullen Scales of Early Learning - Visual Reception Age-equivalent Score
Time Frame: At baseline visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the mean baseline age-equivalent scores from the Visual Reception scale.
This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table.
Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.
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At baseline visit
|
Mullen Scales of Early Learning - Visual Reception Age-equivalent Score
Time Frame: At six-month visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the mean age-equivalent scores from the Visual Reception scale at the 6-month follow-up visit.
This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table.
Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.
|
At six-month visit
|
Mullen Scales of Early Learning - Fine Motor Raw Score
Time Frame: At six-month visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the mean raw scores from the Fine Motor scale at the 6-month follow-up visit.
This scale's raw scores range from 0 to 49.
The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.
|
At six-month visit
|
Mullen Scales of Early Learning - Fine Motor Age-equivalent Score
Time Frame: At baseline visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the mean baseline age-equivalent scores from the Fine Motor scale.
This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table.
Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.
|
At baseline visit
|
Mullen Scales of Early Learning - Fine Motor Age-equivalent Score
Time Frame: At six-month visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language.
Shown here are the mean age-equivalent scores from the Fine Motor scale at the 6-month follow-up visit.
This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table.
Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.
|
At six-month visit
|
Mullen Scales of Early Learning - Cognitive T Score Sum
Time Frame: At baseline visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language.
Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately.
Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability.
Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability.
The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline cognitive T score sums for the placebo and treatment groups are shown here.
|
At baseline visit
|
Mullen Scales of Early Learning - Cognitive T Score Sum
Time Frame: At six-month visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language.
Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately.
Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability.
Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability.
The MSEL was administered at the baseline and 6-month follow-up visits, and mean cognitive T score sums from the 6-month follow-up visit for the placebo and treatment groups are shown here.
|
At six-month visit
|
Mullen Scales of Early Learning - Summary Age-equivalent Score
Time Frame: At baseline visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language.
Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability.
Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages.
The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline summary age-equivalent scores for the placebo and treatment groups are shown here.
|
At baseline visit
|
Mullen Scales of Early Learning - Summary Age-equivalent Score
Time Frame: At six-month visit
|
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development.
The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language.
Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability.
Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages.
The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean summary age-equivalent scores at the 6-month follow-up visit for the placebo and treatment groups are shown here.
|
At six-month visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Randi J Hagerman, MD, UC Davis MIND Institute
- Principal Investigator: Kathleen Angkustsiri, MD, UC Davis MIND Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Mental Retardation, X-Linked
- Intellectual Disability
- Heredodegenerative Disorders, Nervous System
- Chromosome Disorders
- Sex Chromosome Disorders
- Syndrome
- Fragile X Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- 271070
- R40MC22641 (Other Grant/Funding Number: Health Resources and Services Administration (HRSA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fragile X Syndrome
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University of California, DavisNational Institute of Mental Health (NIMH)CompletedFragile X PremutationUnited States
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University of California, DavisNational Institute on Aging (NIA); Forest LaboratoriesCompletedFragile X-Associated Tremor/Ataxia Syndrome | Fragile X Premutation CarriersUnited States
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Ovid Therapeutics Inc.CompletedFragile X Syndrome (FXS)United States
-
Guido A. Davidzon, MD, SMWithdrawn
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Marinus PharmaceuticalsUniversity of California, Davis; U.S. Army Medical Research and Development...Completed
-
RTI InternationalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedFragile X Syndrome (FXS)United States
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Novartis PharmaceuticalsTerminated
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Sheba Medical CenterElMindA LtdRecruitingFragile X Associated Tremor-ataxia Syndrome | FXTASIsrael
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University of California, DavisUniversity of Alberta; St. Justine's HospitalRecruitingNeurobehavioral Manifestations | Genetic Diseases, X-Linked | Intellectual Disability | Fragile X Syndrome | Sex Chromosome Disorders | Fragile X Mental Retardation Syndrome | Trinucleotide Repeat Expansion | Fra(X) Syndrome | FXS | Mental Retardation, X LinkedUnited States, Canada
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University of AlbertaSt. Justine's HospitalRecruitingNeurobehavioral Manifestations | Genetic Diseases, X-Linked | Mental Retardation, X-Linked | Intellectual Disability | Fragile X Syndrome | Sex Chromosome Disorders | Fragile X Mental Retardation Syndrome | Trinucleotide Repeat Expansion | Fra(X) Syndrome | FXSCanada
Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States