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Trial · NCT00905424

Outcomes18

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)Augmentation Baseline, 6 weeks
Primary Efficacy Analysis Set defined as all non-remitters (MADRS total score greater than 10 at augmentation baseline) who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.
Units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCFAugmentation Baseline, 6 weeksPrimary Efficacy Analysis SetUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6Augmentation Baseline, 6 weeksPrimary Efficacy Analysis SetUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYPercentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF6 weeksPrimary Efficacy Analysis SetPercent of ParticipantsNUMBER
SECONDARYAssessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation BaselineAugmentation baselinePrimary Efficacy Analysis SetPercent of participantsNUMBER
SECONDARYAssessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 66 weeksPrimary Efficacy Analysis SetPercent of participantsNUMBER
SECONDARYChange From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6Augmentation Baseline and 6 weeksPrimary Efficacy Analysis SetUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6Augmentation Baseline and 6 weeksPrimary Efficacy Analysis SetUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6Augmentation Baseline and 6 weeksPrimary Efficacy Analysis SetUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCFAugmentation Baseline and 6 weeksFull Analysis Set (FAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.Units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCFAugmentation Baseline and 6 weeksFASUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Remitters in the SDS Total Score at Week 6Augmentation Baseline and 6 weeksFASUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYPercentage of Remitters With Improvement on CGI-I at Week 6 - LOCF6 weeksFASPercent of participantsNUMBER
SECONDARYAssessment in Remitters of CGI-S at Augmentation BaselineAugmentation BaselineFASPercent of participantsNUMBER
SECONDARYAssessment in Remitters of CGI-S at Week 66 weeksFASPercent of participantsNUMBER
SECONDARYChange From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6Augmentation baseline and 6 weeksFASUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6Augmentation baseline and 6 weeksFASUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6Augmentation baseline and 6 weeksFASUnits on a scaleLEAST_SQUARES_MEAN

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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