Trial · NCT01192880
A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia
NCT01192880, Phase 3, Completed, Hoffmann-La Roche
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia. Trials, record NCT01192880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01192880
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia
- NCT number
- NCT01192880
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 625 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Schizophrenia
- Interventions
- Placebo, Bitopertin, Antipsychotics
- First posted
- 2010-09-01
- Last updated
- 2017-02-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Symptom Factor Score at Week 24 | Baseline, Week 24 | |
| Primary | Percentage of Participants with Adverse Events | From baseline up to 24 weeks | |
| Secondary | Mean Change from Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 | Baseline, Week 24 | |
| Secondary | Mean Change from Baseline in the PANSS Total Score at Week 24 | Baseline, Week 24 | |
| Secondary | Mean Change from Baseline in the PANSS Factor Scores at Week 24 | Baseline, Week 24 | |
| Secondary | Mean Change from Baseline in the PANSS Subscale Scores at Week 24 | Baseline, Week 24 | |
| Secondary | Percentage of Participants With Response, as Assessed by PANSS Negative Symptom Factor Score | Week 24 | |
| Secondary | Percentage of Participants with Response, as Assessed by CGI-I Overall and Negative Symptoms Rating Score | Week 24 | |
| Secondary | Percentage of Participants with Both At Least 20% Improvement from Baseline in the PANSS Negative Symptom Factor Score and with a CGI-I Negative Symptoms Rating of Either Much or Very Much Improvement | Week 24 | |
| Secondary | Mean Change from Baseline in the CGI-S Overall and Negative Symptoms Rating Score | Baseline, Week 24 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01192880
GET https://conductscience.org/api/trials/v1/NCT01192880/registered