Trial · NCT00922272
Outcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF) | Open-label Baseline and Week 10 Open-label Phase | Open-label Phase Full Analysis Set (FAS) defined as all enrolled subjects who took at least 1 dose of the investigational product and had 1 primary efficacy assessment after baseline in the Open-label Phase. | Units on a scale | MEAN |
| SECONDARY | Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase | Week 10 Open-label Phase | FAS | Percent of participants | NUMBER |
| PRIMARY | Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF) | Double-blind Randomization Baseline and Week 4 Double-blind Phase | Randomized Evaluable Set (RES) defined as all randomized subjects who were responders (Response is defined as reduction in total SANS score of greater than or equal to 20%) at the Double-blind Randomization and had SANS-18 total scores at week 4 of the Double-blind Phase or the early termination visit. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase | Week 4 Double-blind Phase | RES | Percent of participants | NUMBER |
| SECONDARY | Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase | Open-label Baseline and Week 10 Open-label Phase | FAS | Units on a scale | MEAN |
| SECONDARY | Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase | Double-blind Randomization Baseline and Week 4 Double-blind Phase | RES | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF | Open-label Baseline and Week 10 Open-label Phase | FAS | Units on a scale | MEAN |
| SECONDARY | Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF | Double-blind Randomization Baseline and Week 4 Double-blind Phase | Randomized FAS defined as all subjects who received randomized investigational product and had a SANS-18 total scores at week 4 or at the early termination visit. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline | Open-label Baseline | FAS | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With CGI-S at Week 10 Open-label Phase | Week 10 Open-label Phase | FAS | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With CGI-S at Double-blind Randomization Baseline | Double-blind Randomization Baseline | Randomized FAS | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With CGI-S at Week 4 Double-blind Phase | Week 4 Double-blind Phase | Randomized FAS | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase | Open-label Phase Week 10 | FAS | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase | Double-blind Phase Week 4 | Randomized FAS | Percent of participants | NUMBER |
| SECONDARY | Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase | Open-label Baseline and week 10 Open-label Phase | FAS | correct numerals | MEAN |
| SECONDARY | Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase | Double-blind Randomization Baseline and Week 4 | Randomized FAS | correct numerals | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase | Open-label Baseline and week 10 Open-label Phase | FAS | correct sequences | MEAN |
| SECONDARY | Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase | Double-blind Randomization Baseline and Week 4 | Randomized FAS | correct sequences | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase | Open-label Baseline and Week 10 | FAS | words recalled | MEAN |
| SECONDARY | Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase | Double-blind Randomization Baseline and week 4 Double-blind Phase | Randomized FAS | words recalled | LEAST_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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00922272/outcomes