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Trial · NCT00985725

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)Baseline and week 9The Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of randomized investigational product and had at least 1 primary efficacy assessment after baseline.T-scoresLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)Baseline and week 9FASScores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in BRIEF-A T-scores at Week 9, LOCFBaseline and week 9FAST-scoresLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/EndpointBaseline and up to 9 weeks/EndpointFASResponse scoresMEAN
SECONDARYPercent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at BaselineBaselineFASpercentage of participantsNUMBER
SECONDARYPercent of Participants With CGI-S at up to 9 Weeks/EndpointUp to 9 weeks/Endpoint
FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.
percentage of participantsNUMBER
SECONDARYPercentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCFWeek 9FASpercentage of participantsNUMBER
SECONDARYChange From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/EndpointBaseline and up to 9 weeks/Endpoint
FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.
Scores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCFBaseline and week 9
The Safety Analysis Set (SAS) defined as all randomized subjects who took at least 1 dose of investigational product and for whom at least 1 follow-up safety assessment was completed. Only the males from the SAS population were used and not all of them completed this outcome assessment.
Scores on a scaleMEAN
SECONDARYChange From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCFBaseline and week 9Only the females from the SAS population were used and not all of them completed this outcome assessment.Scores on a scaleMEAN
SECONDARYChange From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9Baseline and week 9
FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.
Scores on a scaleMEAN
SECONDARYChange From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/EndpointBaseline and up to 9 weeks/Endpoint
FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.
Scores on a scaleMEAN
SECONDARYChange From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11Baseline and week 11
SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.
Scores on a scaleMEAN
SECONDARYChange From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCFBaseline and week 9SASScores on a scaleMEAN
SECONDARYChange From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9Baseline and week 9
SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.
Scores on a scaleMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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