Trial · NCT06107803
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
NCT06107803, Phase 1, Completed, Minerva Neurosciences; results first posted 2025-03-26
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia. Trials, record NCT06107803. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06107803
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
- NCT number
- NCT06107803
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 17 participants, actual
- Lead sponsor
- Minerva Neurosciences
- Conditions
- Negative Symptoms in Schizophrenia
- Interventions
- Roluperidone 64 mg, Olanzapine 10 MG
- First posted
- 2023-10-30
- Last updated
- 2025-03-26
- Results first posted
- 2025-03-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Extrapyramidal Symptoms Assessed by Abnormal Involuntary Movement Scale (AIMS) - Change From Baseline in AIMS Component Movement | Overall Safety Set | 0.0 | Standard Deviation 0.00 | score on a scale | |
| Barnes Akathisia Rating Scale (BARS) | Overall Safety Set | 0.0 | Standard Deviation 0.00 | score on a scale | |
| Number of Subjects Who Experienced Suicidal Ideation or Behavior Events Per the Columbia Suicide Severity Rating Scale (C-SSRS) | Overall Safety Set | 0 | Participants | ||
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 1 | 32.5 | Standard Deviation 13.7 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 1 - Day 1 | 5.00 | Standard Deviation 5.69 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 7 | 43.6 | Standard Deviation 19.9 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 1 - Day 7 | 7.98 | Standard Deviation 6.78 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Roluperidone | Treatment Phase 2 - Day 17 | 67.7 | Standard Deviation 28.6 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 2 - Day 17 | 12.2 | Standard Deviation 12.9 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 1 | 9.74 | Standard Deviation 7.37 | hr |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Safety Set | 17 | |
| Overall Study | Full Set | Overall Safety Set | 17 | |
| Overall Study | Safety Set | Overall Safety Set | 17 | |
| Overall Study | Pharmacokinetic Set | Overall Safety Set | 12 | |
| Overall Study | Pharmacokinetic Completer Set | Overall Safety Set | 11 | |
| Overall Study | COMPLETED | Overall Safety Set | 13 | |
| Overall Study | NOT COMPLETED | Overall Safety Set | 4 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Treatment Phase 1 | 0 | 17 | 0 |
| other | Dizziness | Nervous system disorders | Treatment Phase 2 | 3 | 15 | 3 |
| other | Headache | Nervous system disorders | Treatment Phase 1 | 2 | 17 | 2 |
| other | Headache | Nervous system disorders | Treatment Phase 2 | 0 | 15 | 0 |
| other | Somnolence | Nervous system disorders | Treatment Phase 1 | 0 | 17 | 0 |
| other | Somnolence | Nervous system disorders | Treatment Phase 2 | 2 | 15 | 2 |
| other | Presyncope | Nervous system disorders | Treatment Phase 1 | 1 | 17 | 1 |
| other | Presyncope | Nervous system disorders | Treatment Phase 2 | 0 | 15 | 0 |
| other | Syncope | Nervous system disorders | Treatment Phase 1 | 0 | 17 | 0 |
| other | Syncope | Nervous system disorders | Treatment Phase 2 | 1 | 15 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Phase 1 | 0 | 17 |
| Total, all-cause mortality | Treatment Phase 2 | 0 | 15 |
| Total, other adverse events | Treatment Phase 1 | 5 | 17 |
| Total, other adverse events | Treatment Phase 2 | 5 | 15 |
| Total, serious adverse events | Treatment Phase 1 | 1 | 17 |
| Total, serious adverse events | Treatment Phase 2 | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Phase 1 vs Treatment Phase 2: deaths from any cause | Trial comparisons |
| Treatment Phase 1 vs Treatment Phase 2: serious adverse events | Trial comparisons |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 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/NCT06107803
GET https://conductscience.org/api/trials/v1/NCT06107803/results?page=2