Trial · NCT04235686
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) score | Baseline to week 8 visit 10 | Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60) between Baseline and Week 8 visit 10 |
| Secondary | Change in Quick Inventory for Depressive Symptomatology (QIDS-C and QIDS-SR) score | Baseline to Week 8 visit 10 | Reduction in Clinician and self-report symptoms of depression as measured by the Quick Inventory for Depressive Symptomatology (QIDS-C and QIDS-SR) (Range: 0-27) |
| Secondary | Remission | Baseline to Week 8 visit 10 | Treatment remission (Montgomery-Asberg Depression Rating Scale (MADRS) score \< 10) (Range 0-60) |
| Secondary | Change in General Anxiety Disorder 7-item scale score | Baseline to Week 8 visit 10 | Self-report anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7) (Range: 0-21) |
| Secondary | Response | Baseline to Week 8 visit 10 | Treatment response (50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60) |
| Secondary | Change in Clinical Global Impression for Bipolar Disorder (CGI-BP) score | Baseline to Week 8 visit 10 | Percentage of much or very much improved as measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) (Range: 1-8) |
| Secondary | Change in Young Mania Rating Scale (YMRS) score | Baseline to Week 8 visit 10 | Reduction in sub-syndromal manic symptoms as measured by the Young Mania Rating Scale (YMRS) (Range: 0-56) |
| Secondary | Change in Epworth Sleepiness Scale (ESS) score | Baseline to Week 8 visit 10 | Self-report likelihood of falling asleep during normal daily situations as measured by the Epworth Sleepiness Scale (ESS) (Range: 0-24) |
| Secondary | Change in Fatigue Severity Scale (FSS) score | Baseline to Week 8 visit 10 | Self-report measure of fatigue as measured by the Fatigue Severity Scale (FSS) (Range: 0-63) |
| Secondary | Change in Binge Eating Scale (BES) score | Baseline to Week 8 visit 10 | Self-report binge eating behavior as measured by the Binge Eating Scale (BES) (Range: 0-48) |
| Secondary | Change in Morningness-Eveningness Questionnaire (MEQ) score | Baseline to Week 8 visit 10 | Self-Report measure on the Morningness-Eveningness Questionnaire (MEQ) (Range: 16-86) |
| Secondary | Change in Rapid Eating and Activity Assessment for Patients (REAP) score | Baseline to Week 8 visit 10 | Self-Report measure on Rapid Eating and Activity Assessment for Patients (REAP) (Range: 0-27) |
| Secondary | Change in Digit Symbol Substitution Test (DSST) score | Baseline to Week 8 visit 10 | Improvement in cognition as measured by the Digit Symbol Substitution Test (DSST) (Range: 0-100) |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04235686/registered