Trial · NCT01674361
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14 | |
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14 | |
| Secondary | Percentage of Participants with Response as per Pre-defined Criteria Based on the Y-BOCS and CGI | Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 | Response will be defined as having: At least a 35 percent (%) reduction on the total Y-BOCS score from baseline. A much or very much improved on the Clinical Global Impression of Change (CGI-C) rating from baseline. A combination of at least 35% reduction on the total Y-BOCS score from baseline and much or very much improved on the CGI-C from baseline. Achieved remission, as shown by a total Y-BOCS score less than or equal to (≤)10. |
| Secondary | Change From Baseline in Global Social Functioning Using Sheehan Disability Scale (SDS) Total Score After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14 | |
| Secondary | Change From Baseline in Global Social Functioning Using SDS Domain Scores After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 | |
| Secondary | Change From Baseline in Obsessive Compulsive Inventory-Revised (OCI-R) Score After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 | |
| Secondary | Change From Baseline in Columbia Suicide Severity Rating Scale After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 | |
| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 | |
| Secondary | Change From Baseline in SF-36 - Physical Component Summary After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 | |
| Secondary | Change From Baseline in SF-36 - Domain Scores After 12 Weeks of Treatment | Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 | |
| Secondary | Area Under The Concentration-Time Curve of Bitopertin | Pre-dose (0 hour) on Day 56 (Week 8), Day 84 (Week 12), Day 98 (Week 14), Day 112 (Week 16); 3 and 6 hours post-dose on Day 112 (Week 16) |
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/NCT01674361/registered