- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02189213
Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- NYSPI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Participants aged 8-25 years inclusive at the time of the consent/assent, either outpatient or inpatient if hospitalization is required for one of the following reasons:
- It is presently unsafe for subject to stay at home because he/she may run away
- Subject needs closer monitoring while being started on medications
- Subject needs a level of care that is greater than once a week outpatient treatment and is willing to participate in the study.
- Participant's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent by the participant.
- Participant meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) or Fifth Edition (DSM-V) criteria for a clinically impairing anxiety disorder based on detailed psychiatric evaluation at screening including completion of the Anxiety Disorders Interview Schedule for DSM-IV or DSM-V Child Version (ADIS-C) and a Children's Global Assessment Scale (CGAS) score less than 65.
Participants who are female of child-bearing potential (defined as ≥9 years of age or if <9 years of age are post-menarchal) must have a negative urine pregnancy test at the Baseline Visit. Females of child-bearing potential must abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception. Condoms should be used with the following acceptable contraceptives:
- Intrauterine devices,
- Hormonal contraceptives (oral, depot, patch, injectable, or vaginal ring).
- Other acceptable contraceptive methods are double barrier methods (e.g., condoms and diaphragms with spermicidal gel or foam).
Exclusion Criteria:
- Participant has a current co-morbid psychiatric diagnosis of bipolar disorder, psychosis, a pervasive developmental disorder other than Asperger's Syndrome, an eating disorder, substance abuse disorder, or a sleep disorder of narcolepsy and/or sleep apnea.
- Participant has any condition or illness which, in the opinion of the study doctor, represents as an inappropriate risk to the participant and/or could confound the interpretation of the study.
- Participant has received any evidence-based psychosocial intervention in the past 6 weeks i.e. Individual Cognitive Behavioral Therapy, Group Cognitive Behavioral Therapy, or Social Effectiveness Training.
- Participant is unwilling or unable to provide blood, urine, and/or saliva samples at designated visits.
- Participant is female and is pregnant or is currently lactating.
- Participant is currently considered at risk for suicide in the opinion of the study doctor, has made a suicide attempt within the past 6 months, or is currently reporting active suicidal ideation. Participants with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the study doctor. Control participants with any suicidal ideation will not be eligible for the study.
- Participant has had a substance use disorder within the past 6 months.
- Participant has a clinically important abnormality on drug and alcohol screen.
- Participant has started or changed the dosage of medication (including herbal supplements) that has anxiolytic, anxiogenic, or central nervous system (CNS) effects within the past 3 months.
- Participant has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to any components found in the study drug.
- Participant has had several failed attempts with SSRI treatment.
- Participant has an acute illness and/or is taking short term medication at the time of initiation of the study.
- Participant failed screening or was previously enrolled in this study
- Participant is unable to read.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Sertraline
Sertraline will be administered PO to treat anxiety disorders in children and adolescents.
he following dosing schedules will be used: Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks.
The titration will stop at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration.
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Sertraline will be administered to treat anxiety disorders in children and adolescents.
Other Names:
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No Intervention: Control
There will be no intervention in this arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression-Improvement (CGI-I) Score
Time Frame: Final visit, at 12 weeks of treatment
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The CGI-I score at the final visit will determine treatment response. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment. |
Final visit, at 12 weeks of treatment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amir Levine, New York State Psychiatric Institue
Study record dates
Study Major Dates
Study Start (Actual)
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
- Mental Disorders
- Pathologic Processes
- Neurodevelopmental Disorders
- Phobic Disorders
- Disease
- Anxiety Disorders
- Phobia, Social
- Anxiety, Separation
- 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
- 6884 (Other Identifier: CTEP)
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.
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