Trial · NCT06107803
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Extrapyramidal Symptoms Assessed by Abnormal Involuntary Movement Scale (AIMS) - Change From Baseline in AIMS Component Movement | Overall - Change from Baseline to End of Study (Day 17) | score on a scale | MEAN | |
| PRIMARY | Barnes Akathisia Rating Scale (BARS) | Overall - Change from Baseline to End of Study (Day 17) | score on a scale | MEAN | |
| PRIMARY | Number of Subjects Who Experienced Suicidal Ideation or Behavior Events Per the Columbia Suicide Severity Rating Scale (C-SSRS) | Overall - End of Study (Day 17) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Days 1 through 17 | Treatment Phase 1 - Day 7 had 15 participants analyzed. Treatment Phase 2 - Day 17 had 13 participants analyzed. | ng/ml | MEAN |
| SECONDARY | Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Days 1 through 17 | Treatment Phase 1 - Day 7 had 15 participants analyzed. Treatment Phase 2 - Day 17 had 13 participants analyzed. | hr | MEAN |
| SECONDARY | Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC 0-24) | Days 1 through 17 | Treatment Phase 1 - Day 7 had 15 participants analyzed. Treatment Phase 2 - Day 17 had 13 participants analyzed. | hr*ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC Inf) | Days 1 through 17 | Treatment Phase 1 - Day 7 had 15 participants analyzed. Treatment Phase 2 - Day 17 had 13 participants analyzed. | hr*ng/mL | MEAN |
| SECONDARY | Plasma PK Parameter for Olanzapine Cmax | Treatment Phase 2 (Day 8 through Day 17) | ng/ml | MEAN | |
| SECONDARY | Plasma PK Parameter for Olanzapine Tmax | Treatment Phase 2 (Day 8 through Day 17) | hr | MEAN | |
| SECONDARY | Plasma PK Parameter for Olanzapine AUC 0-24 | Treatment Phase 2 (Day 8 through Day 17) | hr*ng/ml | MEAN | |
| SECONDARY | Plasma PK Parameter for Olanzapine AUC Inf | Treatment Phase 2 (Day 8 through Day 17) | hr*ng/ml | MEAN | |
| SECONDARY | Pharmacokinetic Evaluation of Co-administration Versus Roluperidone Monotherapy - Maximum Plasma Concentration (Cmax) | Days 1 through 17 | ng/ml | GEOMETRIC_MEAN | |
| SECONDARY | Pharmacokinetic Evaluation of Co-administration - AUC 0-24 | Days 1 through 17 | hr*ng/ml | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06107803/outcomes