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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05303064
The ClinicalTrials.gov registry entry for NCT05303064 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target. The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.