Trial · NCT05303064
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
NCT05303064, Phase 3, Recruiting, Alkermes, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder. Trials, record NCT05303064. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05303064
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
- NCT number
- NCT05303064
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 220 participants, estimated
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Schizophrenia, Bipolar I Disorder
- Interventions
- OLZ/SAM, Olanzapine
- First posted
- 2022-03-31
- Last updated
- 2026-08-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in body mass index (BMI) Zscore at week 12 | 12 weeks | To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine |
| Secondary | Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12 | 12 weeks | To compare subjects with clinical significant BMI Z-score increase with OLZ/SAM vs olanzapine |
| Secondary | Time to all-cause discontinuation of study drug over 52 weeks | Up to 52 weeks | To compare time to all-cause discontinuation of study drug with OLZ/SAM vs olanzapine |
| Secondary | Change from baseline in waist circumference | 12 weeks | To compare the change from baseline in waist circumference with OLZ/SAM vs olanzapine |
| Secondary | Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit | 12 weeks | To compare the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score with OLZ/SAM vs olanzapine for patients with schizophrenia |
| Secondary | Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder | 12 weeks | To compare the change from baseline in YMRS with OLZ/SAM vs olanzapine for patients with bipolar I disorder |
| Secondary | Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit | 12 weeks | To compare the change from baseline in CDRS-R with OLZ/SAM vs olanzapine for patients with bipolar I disorder |
| Secondary | Incidence of Adverse Events | Up to 52 weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05303064
GET https://conductscience.org/api/trials/v1/NCT05303064/registered