Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064 · View on ClinicalTrials.gov ↗

Study Summary

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

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

FieldValue
Enrollment Target 220 participants
Start Date 2022-06-30
Est. Completion 2026-09
Phase Phase 3

Sponsor

Alkermes

19 total trials

Interested in This Trial?

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 19 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05303064 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05303064?

The interventions under investigation include: Olanzapine (DRUG), OLZ/SAM (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05303064?

This trial is sponsored by Alkermes, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial