Trial · NCT01052103
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16) | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline NSA-16 total score measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PANSS total score measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline CGI-S measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline MCCB overall composite T-score measurement. | T-scores | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline UPSA-B total score measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Barnes-Akathisia Scale (BAS) Global Score | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline BAS global score measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Simpson Angus Scale (SAS) Total Score | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline SAS total score measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline AIMS 1-7 total score measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Incidence of Epileptiform Activity Outside of Normal Range in Electroencephalograms (EEGs) | Baseline to randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline EEG measurement. | participants | NUMBER |
| SECONDARY | Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs) | Baseline to randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline ECG QTcF measurement. | participants | NUMBER |
| SECONDARY | Percentage of Participants With a Worsening of Neurological Symptoms From Baseline to Endpoint on the Neurological Examination | Baseline to randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline neurological examination. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Standing Blood Pressure (BP) | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline standing BP measurement. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Standing Pulse Rate | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline standing pulse rate measurement. | beats per minute (bpm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weight | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline weight measurement. | kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - General | Baseline to randomization treatment Week 16 | All randomized participants who received at least one dose of study drug and had at least one post-baseline laboratory measurement. | participants | NUMBER |
| SECONDARY | Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Cholesterol | Baseline to randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had normal or borderline cholesterol level at baseline and at least one post-baseline cholesterol measurement. Number represents number of participants with an incidence of potentially clinically significant (PCS) change in laboratory values | participants | NUMBER |
| SECONDARY | Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Triglycerides | Baseline to randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had normal or borderline triglycerides level at baseline and at least one post-baseline triglycerides measurement. Number represents number of participants with an incidence of potentially clinically significant (PCS) change in laboratory values | participants | NUMBER |
| SECONDARY | Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Glucose | Baseline to randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had normal or impaired glucose level at baseline and at least 1 post-baseline glucose measurement. Number represents number of participants with an incidence of potentially clinically significant (PCS) change in laboratory values | participants | NUMBER |
| SECONDARY | Percentage of Participants With Incidence of Potentially Clinically Significant Change of Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline to randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline C-SSRS measurement. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Endpoint in Personal and Social Performance (PSP) Scale | Baseline, randomization treatment Week 16 | All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PSP measurement. | units on a scale | 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.
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GET https://conductscience.org/api/trials/v1/NCT01052103/outcomes