Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia
Public ClinicalTrials.gov record NCT03397134. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of roluperidone in adult schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of roluperidone compared to placebo in improving the negative symptoms of schizophrenia over 12 weeks of double-blind treatment as measured by the change in Positive and Negative Syndrome Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.
Study identification
- NCT ID
- NCT03397134
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 515 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2017 (Actual)
- Primary completion
- May 26, 2020 (Actual)
- Completion
- Feb 15, 2021 (Actual)
- Last update posted
- Apr 28, 2023
2017 – 2021
United States locations
- U.S. sites
- 13
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Collaborative Neuroscience Network, LLC. | Garden Grove | California | 92845 | — |
| Synergy Clinical Center | National City | California | 91950 | — |
| Collaborative Neuroscience Network, LLC. | Torrance | California | 90502 | — |
| Behavioral Clinical Research, Inc | North Miami | Florida | 33161 | — |
| Research Centers of America, LLC | Oakland Park | Florida | 33334 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Uptown Research Institute LLC | Chicago | Illinois | 60640 | — |
| Hassman Research Institute, LLC. | Berlin | New Jersey | 08009 | — |
| The Nathan Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | — |
| InSite Clinical Research LLC | DeSoto | Texas | 75115 | — |
| Pillar Clinical Research LLC | Richardson | Texas | 75080 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03397134, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03397134 live on ClinicalTrials.gov.