Trial · NCT00985725
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change 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 9 | BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. |
| Secondary | Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF) | Baseline and week 9 | MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. |
| Secondary | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Baseline and week 9 | BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. |
| Secondary | Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint | Baseline and up to 9 weeks/Endpoint | This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores \< 70 indicate likely deficit and impairment, and scores \> 110 indicate high function and capacity. Higher scores are better. |
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Baseline | 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) |
| Secondary | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Up to 9 weeks/Endpoint | 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) |
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF | Week 9 | Clinical Global Impression-Improvement (CGI-I) 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. |
| Secondary | Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint | Baseline and up to 9 weeks/Endpoint | The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity. |
| Secondary | Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF | Baseline and week 9 | This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. |
| Secondary | Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF | Baseline and week 9 | This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. |
| Secondary | Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 | Baseline and week 9 | The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health). |
| Secondary | Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint | Baseline and up to 9 weeks/Endpoint | The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction. |
| Secondary | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11 | Baseline and week 11 | 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. |
| Secondary | Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF | Baseline and week 9 | The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety. |
| Secondary | Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9 | Baseline and week 9 | The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies. |
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.
For software
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