- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00922272
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
25 mei 2021 bijgewerkt door: Shire
A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).
Studie Overzicht
Toestand
Voltooid
Studietype
Ingrijpend
Inschrijving (Werkelijk)
92
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72201
- K&S Professional Research Services
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California
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Anaheim, California, Verenigde Staten, 92805
- Omega Clinical Trials
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Anaheim, California, Verenigde Staten, 92804
- South Coast Clinical Trials
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Costa Mesa, California, Verenigde Staten, 92626
- Clinical Innovations
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Garden Grove, California, Verenigde Staten, 92845
- Collaborative Neuroscience Network, Inc.
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Long Beach, California, Verenigde Staten, 90813
- Apostle Clinical Trials, Inc.
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Oceanside, California, Verenigde Staten, 92056
- Excell Research, Inc.
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San Bernardino, California, Verenigde Staten, 92405
- Southcoast Clinical Trials
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San Diego, California, Verenigde Staten, 92123
- Artemis Institute for Clinical Research
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San Diego, California, Verenigde Staten, 92108
- Affiliated Research Institute
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San Diego, California, Verenigde Staten, 92102
- CNRI San Diego & Los Angeles
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Santa Ana, California, Verenigde Staten, 92701
- Neuropsychiatric Research Center of Orange County
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Florida
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Kissimmee, Florida, Verenigde Staten, 34741
- Accurate Clinical Trials
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Lauderhill, Florida, Verenigde Staten, 33319
- Behavioral Clinical Research, Inc
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North Miami, Florida, Verenigde Staten, 33161
- Segal Institute for Clinical Research (Miami)
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Orange City, Florida, Verenigde Staten, 32763
- Medical Research Group of Central Florida
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Tampa, Florida, Verenigde Staten, 33613
- Stedman Clinical Trials
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30328
- Comprehensive Neuroscience
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Illinois
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Chicago, Illinois, Verenigde Staten, 60640
- Uptown Research Institute
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Louisiana
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Shreveport, Louisiana, Verenigde Staten, 71104
- J. Gary Booker, MD, APMC
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New Jersey
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Willingboro, New Jersey, Verenigde Staten, 08046
- CRI Worldwide, LLC.
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New York
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Elmsford, New York, Verenigde Staten, 10523
- Advanced Bio-Behavioral Sciences
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Hollis, New York, Verenigde Staten, 11423
- Comprehensive NeuroScience, Inc.
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45219
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19139
- CRI Worldwide
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Texas
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Austin, Texas, Verenigde Staten, 78756
- Community Clinical Research, Inc.
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Irving, Texas, Verenigde Staten, 75062
- University Hills Clinical Research
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 55 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Adults aged 18-55
- Clinically stable Schizophrenia and predominant negative symptoms
- Taking a stable dose of antipsychotic medication
Exclusion Criteria:
- Clinically notable positive symptoms defined by PANSS
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
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oral, once daily
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Experimenteel: SPD489 (Lisdexamfetamine-dimesylaat)
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oral, 20, 30, 40, 50, 60, or 70 mg once daily
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)
Tijdsspanne: Open-label Baseline and Week 10 Open-label Phase
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The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score.
Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90.
Higher scores indicate more impairment.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)
Tijdsspanne: Double-blind Randomization Baseline and Week 4 Double-blind Phase
|
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score.
Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90.
Higher scores indicate more impairment.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
Tijdsspanne: Week 10 Open-label Phase
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Response is defined as reduction in total SANS score of greater than or equal to 20%.
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score.
Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90.
Higher scores indicate more impairment.
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Week 10 Open-label Phase
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Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase
Tijdsspanne: Week 4 Double-blind Phase
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Response is defined as reduction in total SANS score of greater than or equal to 20%.
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score.
Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90.
Higher scores indicate more impairment.
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Week 4 Double-blind Phase
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Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and Week 10 Open-label Phase
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The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects.
Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90.
Higher scores indicate more impairment.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase
Tijdsspanne: Double-blind Randomization Baseline and Week 4 Double-blind Phase
|
The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects.
Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90.
Higher scores indicate more impairment.
|
Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF
Tijdsspanne: Open-label Baseline and Week 10 Open-label Phase
|
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology.
Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210.
Higher scores indicate more impairment.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF
Tijdsspanne: Double-blind Randomization Baseline and Week 4 Double-blind Phase
|
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology.
Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210.
Higher scores indicate more impairment.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline
Tijdsspanne: Open-label Baseline
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CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
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Open-label Baseline
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Percent of Participants With CGI-S at Week 10 Open-label Phase
Tijdsspanne: Week 10 Open-label Phase
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CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
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Week 10 Open-label Phase
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Percent of Participants With CGI-S at Double-blind Randomization Baseline
Tijdsspanne: Double-blind Randomization Baseline
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CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
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Double-blind Randomization Baseline
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Percent of Participants With CGI-S at Week 4 Double-blind Phase
Tijdsspanne: Week 4 Double-blind Phase
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CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
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Week 4 Double-blind Phase
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Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase
Tijdsspanne: Open-label Phase Week 10
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CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time.
It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
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Open-label Phase Week 10
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Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase
Tijdsspanne: Double-blind Phase Week 4
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CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time.
It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
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Double-blind Phase Week 4
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Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and week 10 Open-label Phase
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BACS measures attention and speed of processing, and the test score is the total number correct.
The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.
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Open-label Baseline and week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase
Tijdsspanne: Double-blind Randomization Baseline and Week 4
|
BACS measures attention and speed of processing, and the test score is the total number correct.
The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.
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Double-blind Randomization Baseline and Week 4
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Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and week 10 Open-label Phase
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LNS is a test of verbal working memory.
Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence.
The measure is the number of correct sequences.
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Open-label Baseline and week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase
Tijdsspanne: Double-blind Randomization Baseline and Week 4
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LNS is a test of verbal working memory.
Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence.
The measure is the number of correct sequences.
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Double-blind Randomization Baseline and Week 4
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Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and Week 10
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HVLT-R measures verbal learning.
Test scores are the total number of words recalled correctly over 3 trials.
The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.
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Open-label Baseline and Week 10
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Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase
Tijdsspanne: Double-blind Randomization Baseline and week 4 Double-blind Phase
|
HVLT-R measures verbal learning.
Test scores are the total number of words recalled correctly over 3 trials.
The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.
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Double-blind Randomization Baseline and week 4 Double-blind Phase
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Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF
Tijdsspanne: Open-label Baseline and week 10 Open-label Phase
|
UPSA-B assesses skills in 5 areas of life functioning.
It contains 2 subscales.
Percentages correct on these 2 subscales are multiplied by 50.
Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100.
Scores of 75 or higher are associated with independent living.
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Open-label Baseline and week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase
Tijdsspanne: Double-blind Randomization Baseline and Week 4 Double-blind Phase
|
UPSA-B assesses skills in 5 areas of life functioning.
It contains 2 subscales.
Percentages correct on these 2 subscales are multiplied by 50.
Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100.
Scores of 75 or higher are associated with independent living.
|
Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and Week 10 Open-label Phase
|
BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index).
Items are rated 1 (never), 2 (sometimes), and 3 (often).
Raw scale scores are used to generate T-scores.
A reduction in score indicates less impairment.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase
Tijdsspanne: Double-blind Randomization Baseline and Week 4 Double-blind Phase
|
BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index).
Items are rated 1 (never), 2 (sometimes), and 3 (often).
Raw scale scores are used to generate T-scores.
A reduction in score indicates less impairment.
|
Double-blind Randomization Baseline and Week 4 Double-blind Phase
|
Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and Week 10 Open-label Phase
|
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms.
The items are scored on a scale from 0 to 4 with item-specific definitions given for each point.
Total scores range from 0 to 40.
Lower scores indicate less impairment.
|
Open-label Baseline and Week 10 Open-label Phase
|
Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase
Tijdsspanne: Open-label Baseline and Week 4 Double-blind Phase
|
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms.
The items are scored on a scale from 0 to 4 with item-specific definitions given for each point.
Total scores range from 0 to 40.
Lower scores indicate less impairment.
|
Open-label Baseline and Week 4 Double-blind Phase
|
Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and week 10 Open-label Phase
|
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless).
Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
|
Open-label Baseline and week 10 Open-label Phase
|
Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase
Tijdsspanne: Open-label Baseline and Week 4 Double-blind Phase
|
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless).
Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
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Open-label Baseline and Week 4 Double-blind Phase
|
Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and Week 10 Open-label Phase
|
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64.
Higher scores indicate greater withdrawal symptom severity.
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Open-label Baseline and Week 10 Open-label Phase
|
Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase
Tijdsspanne: Double-blind Randomization Baseline and Week 4 Double-blind Phase
|
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64.
Higher scores indicate greater withdrawal symptom severity.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
|
Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and Week 10 Open-label Phase
|
PSQI evaluates 7 areas of quality and pattern of sleep.
Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase
Tijdsspanne: Open-label Baseline and Week 4 Double-blind Phase
|
PSQI evaluates 7 areas of quality and pattern of sleep.
Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
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Open-label Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase
Tijdsspanne: Open-label Baseline and Week 10 Open-label Phase
|
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27.
Lower scores indicate less depression.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase
Tijdsspanne: Open-label Baseline and Week 4 of Double-blind Phase
|
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27.
Lower scores indicate less depression.
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Open-label Baseline and Week 4 of Double-blind Phase
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 september 2009
Primaire voltooiing (Werkelijk)
20 januari 2011
Studie voltooiing (Werkelijk)
20 januari 2011
Studieregistratiedata
Eerst ingediend
15 juni 2009
Eerst ingediend dat voldeed aan de QC-criteria
16 juni 2009
Eerst geplaatst (Schatting)
17 juni 2009
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juni 2021
Laatste update ingediend die voldeed aan QC-criteria
25 mei 2021
Laatst geverifieerd
1 mei 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Schizofreniespectrum en andere psychotische stoornissen
- Schizofrenie
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Neurotransmitter-opnameremmers
- Membraantransportmodulatoren
- Dopamine-agenten
- Dopamine-opnameremmers
- Stimulerende middelen voor het centrale zenuwstelsel
- Lisdexamfetamine Dimesylaat
Andere studie-ID-nummers
- SPD489-204
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op SPD489 (lisdexamfetamine dimesylate)
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-
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ShireIngetrokkenNegatieve symptomen van schizofrenie
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-
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