Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04865835 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.
A Phase 1 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT04865835: Completed Phase 1 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04865835 is a Phase 1 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 21 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04865835, a Phase 1 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on the way that the drug Metformin travels through the body in people with schizophrenia. This clinical trial will have approximately 24 subjects both male and female 18 year of age and older. This study will be conducted in approximately 2 study sites in the United States.
Primary Outcome
area under the plasma concentration-time curve from time zero to infinity (AUC0 ∞) or area under the plasma concentration-time curve from time zero to a defined time (AUC0-t), if appropriate
Conditions Studied
Interventions
- DRUG placebo
- DRUG metformin
- DRUG SEP-363856
Study Locations (2)
Florida
- At Fort Lauderdale Behavioral Health Center - Oakland Park
New Jersey
- Hassman Research Institute - Marlton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-05-12 |
| Est. Completion | 2022-05-03 |
| Phase | Phase 1 |
What the finished NCT04865835 record still lists
NCT04865835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT04865835 reports a single indexed study location in Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT04865835 about?
NCT04865835 is a clinical study titled "A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.". A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on the way that the drug Metformin travels through the body in people with schizophrenia. This clinical trial will have approximately 24 subjects both male and female 18 year of age and older. This study will ...
What is the current status of trial NCT04865835?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2021-05-12. Estimated completion is 2022-05-03.
What conditions does trial NCT04865835 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT04865835?
The interventions under investigation include: placebo (DRUG), metformin (DRUG), SEP-363856 (DRUG).
Who is sponsoring clinical trial NCT04865835?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04865835 being conducted?
This trial has 2 study locations across Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04865835's enrollment target sits among peer trials
21 282nd of 315 higher than 31 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Tolerability of MDMA in Schizophrenia
RECRUITING · Phase 1
-
Imaging Synapses With [11C] UCB-J in the Human Brain
RECRUITING · Phase 1
-
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
RECRUITING · Phase 1
-
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
RECRUITING · Phase 1
-
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
RECRUITING · Phase 1
-
Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI