Trial · NCT02515773
Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
NCT02515773, Phase 4, Completed, Melissa Delbello; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs. Trials, record NCT02515773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02515773
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
- NCT number
- NCT02515773
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,565 participants, actual
- Lead sponsor
- Melissa Delbello
- Conditions
- Bipolar Disorder
- Interventions
- Metformin, healthy lifestyle intervention (LIFE)
- First posted
- 2015-08-05
- Last updated
- 2025-01-14
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in BMI Z-score From Baseline to Month 6 in ITT Sample | Baseline to Month 6 | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. |
| Primary | Change in BMI Z-score From Baseline to Month 24 in ITT Sample | Baseline to Month 24 | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. |
| Primary | Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample | Baseline to Month 6 | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. |
| Primary | Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample | Baseline to Month 24 | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in BMI Z-score From Baseline to Month 6 in ITT Sample | Baseline to Month 6 | Modified intention-to-treat (ITT) sample consisting of patients who initiated randomized treatment and had at least one post-baseline assessment. | Z-score | MEAN |
| PRIMARY | Change in BMI Z-score From Baseline to Month 24 in ITT Sample | Baseline to Month 24 | Modified intention-to-treat (ITT) sample consisting of patients who initiated randomized treatment and had at least one post-baseline assessment. | Z-score | MEAN |
| PRIMARY | Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample | Baseline to Month 6 | Per protocol sample consisting of patients who had continuously followed their randomized treatment through month 6 | Z-score | MEAN |
| PRIMARY | Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample | Baseline to Month 24 | Per protocol sample consisting of patients who had continuously followed their randomized treatment through month 24 | Z-score | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in BMI Z-score From Baseline to Month 6 in ITT Sample | MET and LIFE | -0.08 | Standard Deviation 0.29 | Z-score | |
| Change in BMI Z-score From Baseline to Month 6 in ITT Sample | Healthy Lifestyle Intervention (LIFE) | 0.00 | Standard Deviation 0.29 | Z-score | |
| Change in BMI Z-score From Baseline to Month 24 in ITT Sample | MET and LIFE | -0.19 | Standard Deviation 1.00 | Z-score | |
| Change in BMI Z-score From Baseline to Month 24 in ITT Sample | Healthy Lifestyle Intervention (LIFE) | -0.11 | Standard Deviation 0.87 | Z-score | |
| Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample | MET and LIFE | -0.09 | Standard Deviation 0.46 | Z-score | |
| Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample | Healthy Lifestyle Intervention (LIFE) | 0.00 | Standard Deviation 0.42 | Z-score | |
| Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample | MET and LIFE | -0.21 | Standard Deviation 1.11 | Z-score | |
| Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample | Healthy Lifestyle Intervention (LIFE) | -0.12 | Standard Deviation 1.01 | Z-score |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MET and LIFE | 579 | |
| Overall Study | STARTED | Healthy Lifestyle Intervention (LIFE) | 720 | |
| Overall Study | Followed Randomized Treatment (Per-protocol Sample) | MET and LIFE | 558 | |
| Overall Study | Followed Randomized Treatment (Per-protocol Sample) | Healthy Lifestyle Intervention (LIFE) | 686 | |
| Overall Study | COMPLETED | MET and LIFE | 360 | |
| Overall Study | COMPLETED | Healthy Lifestyle Intervention (LIFE) | 454 | |
| Overall Study | NOT COMPLETED | MET and LIFE | 219 | |
| Overall Study | NOT COMPLETED | Healthy Lifestyle Intervention (LIFE) | 266 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increased Appetite | General disorders | MET and LIFE | 56 | 558 | |
| other | Increased Appetite | General disorders | Healthy Lifestyle Intervention (LIFE) | 91 | 686 | |
| other | Sedation | General disorders | MET and LIFE | 20 | 558 | |
| other | Sedation | General disorders | Healthy Lifestyle Intervention (LIFE) | 41 | 686 | |
| other | Headache | General disorders | MET and LIFE | 24 | 558 | |
| other | Headache | General disorders | Healthy Lifestyle Intervention (LIFE) | 31 | 686 | |
| other | Somnolence | General disorders | MET and LIFE | 14 | 558 | |
| other | Somnolence | General disorders | Healthy Lifestyle Intervention (LIFE) | 20 | 686 | |
| other | Fatigue | General disorders | MET and LIFE | 11 | 558 | |
| other | Fatigue | General disorders | Healthy Lifestyle Intervention (LIFE) | 21 | 686 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MET and LIFE | 0 | 579 |
| Total, all-cause mortality | Healthy Lifestyle Intervention (LIFE) | 0 | 720 |
| Total, other adverse events | MET and LIFE | 352 | 558 |
| Total, other adverse events | Healthy Lifestyle Intervention (LIFE) | 339 | 686 |
| Total, serious adverse events | MET and LIFE | 12 | 579 |
| Total, serious adverse events | Healthy Lifestyle Intervention (LIFE) | 25 | 720 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MET and LIFE vs Healthy Lifestyle Intervention (LIFE): deaths from any cause | Trial comparisons |
| MET and LIFE vs Healthy Lifestyle Intervention (LIFE): serious adverse events | Trial comparisons |
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT02515773
GET https://conductscience.org/api/trials/v1/NCT02515773/events?page=2