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NCT05303064 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
A Phase 3 study of Schizophrenia and Bipolar I Disorder, sponsored by Alkermes.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT05303064: Recruiting Phase 3 study of Schizophrenia and Bipolar I Disorder, sponsored by Alkermes.
NCT05303064 is a Phase 3 study of Schizophrenia and Bipolar I Disorder that is actively recruiting participants, run by Alkermes. The registered enrollment target is 220 participants, roughly in line with the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05303064, a Phase 3 study of Schizophrenia and Bipolar I Disorder, is actively recruiting participants, sponsored by Alkermes.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Primary Outcome
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Conditions Studied
Interventions
- DRUG Olanzapine
- DRUG OLZ/SAM
Study Locations (20)
California
- Alkermes Investigator Site - Encino
- Alkermes Investigator Site - Stanford
- Alkermes Investigator Site - Upland
Colorado
- Alkermes Investigator Site - Colorado Springs
- Alkermes Investigator Site - Denver
Florida
- Alkermes Investigator Site - Miami
- Alkermes Investigator Site - Miami Lakes
Nebraska
- Alkermes Investigator Site - Lincoln
- Alkermes Investigator Site - Omaha
Alabama
- Alkermes Investigator Site - Dothan
Arkansas
- Alkermes Investigator Site - Little Rock
Connecticut
- Alkermes Investigator Site - Hartford
District of Columbia
- Alkermes Investigator Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2026-09 |
| Phase | Phase 3 |
What NCT05303064 shows while recruiting
NCT05303064 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Olanzapine is the first listed.
NCT05303064 names 20 study sites across 15 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT05303064 about?
NCT05303064 is a clinical study titled "Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder". To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
What is the current status of trial NCT05303064?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2022-06-30. Estimated completion is 2026-09.
What conditions does trial NCT05303064 study?
This clinical trial studies the following conditions: Schizophrenia, Bipolar I Disorder.
What interventions are being tested in trial NCT05303064?
The interventions under investigation include: Olanzapine (DRUG), OLZ/SAM (DRUG).
Who is sponsoring clinical trial NCT05303064?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05303064 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. 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 NCT05303064's enrollment target sits among peer trials
220 82nd of 315 higher than 234 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
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