Trial · NCT06107803
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | AIMS is a rating scale to measure tardive dyskinesia (TD). For the scoring, the AIMS scale has 14 items. The first 10 items (under categories of Facial and Oral Movements, Extremity Movements, Trunk Movements, and Global Judgements) are rated from 0 (none) to 4 (severe); the remaining 4 items (Dental Status) are rated "yes" and "no" and not counted. The analysis is limited to items 1 to 10, with each rated from 0 to 4. The total score is the sum of all 10 items and with values ranging from 0 to 40. Overall change from baseline to End of Study (Day 17) in AIMS was reported for the Safety Set. Higher scores imply worse outcome. |
| Primary | Barnes Akathisia Rating Scale (BARS) | Overall - Change from Baseline to End of Study (Day 17) | BARS is a multiple-choice questionnaire that clinicians may use to provide an assessment of akathisia. The clinician or rater is instructed to observe the subject while standing and while sitting, at least 2 minutes each (total of at least 4 minutes in total). There are 4 areas where the subject is to be evaluated, 1 of these is objective, 2 are subjective, and the final is a global assessment. The BARS scale has 3 items that are rated from 0 (absence/no distress) to 3 (most severe). The BARS rating scale is scored by summing the scales for Objective Akathisia, Subjective Awareness of Restlessness and Subjective Distress Related to Restlessness yielding a total score ranging from 0 to 9. The Total score, which has a possible range from 0-9, is reported. Higher scores imply worse outcome. |
| 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) | C-SSRS is a measure to identify and assess individuals at risk for suicide. Questions are phrased for an interview format but can be completed as a self-report measure if needed. It measures 4 constructs: severity of ideation, intensity of ideation, behavior, and lethality. It includes "stem questions," which if endorsed, prompt additional follow-up questions to obtain more information. For the composite endpoint of suicidal ideation or behavior (1-10), the number and percent of subjects in the Overall Safety Set who experience any one of the ten suicidal ideation or behavior events at End of Study (Day 17). |
| Secondary | Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Days 1 through 17 | Cmax of roluperidone and its metabolite following single dose and at steady state, and when administered concomitantly with olanzapine. |
| Secondary | Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Days 1 through 17 | Tmax of roluperidone and its metabolite following single dose and at steady state, and when administered concomitantly with olanzapine. |
| Secondary | Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC 0-24) | Days 1 through 17 | AUC of roluperidone and its metabolite following single dose and at steady state, and when administered concomitantly with olanzapine. |
| Secondary | Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC Inf) | Days 1 through 17 | AUC of roluperidone and its metabolite following single dose and at steady state, and when administered concomitantly with olanzapine. |
| Secondary | Plasma PK Parameter for Olanzapine Cmax | Treatment Phase 2 (Day 8 through Day 17) | Cmax of olanzapine administered concomitantly with roluperidone |
| Secondary | Plasma PK Parameter for Olanzapine Tmax | Treatment Phase 2 (Day 8 through Day 17) | Tmax of olanzapine administered concomitantly with roluperidone |
| Secondary | Plasma PK Parameter for Olanzapine AUC 0-24 | Treatment Phase 2 (Day 8 through Day 17) | AUC 0-24 olanzapine administered concomitantly with roluperidone |
| Secondary | Plasma PK Parameter for Olanzapine AUC Inf | Treatment Phase 2 (Day 8 through Day 17) | AUC inf olanzapine administered concomitantly with roluperidone |
| Secondary | Pharmacokinetic Evaluation of Co-administration Versus Roluperidone Monotherapy - Maximum Plasma Concentration (Cmax) | Days 1 through 17 | Comparison of roluperidone on Day 17 with olanzapine to roluperidone alone on Day 7 for Cmax. The geometric mean and geometric coefficient of variation are reported for the analytes roluperidone and its metabolite. |
| Secondary | Pharmacokinetic Evaluation of Co-administration - AUC 0-24 | Days 1 through 17 | Comparison of roluperidone on Day 17 with olanzapine to roluperidone alone on Day 7 for AUC 0-24. The geometric mean and geometric coefficient of variation are reported for the analytes roluperidone and its metabolite. |
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.
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