Trial · NCT01825798
Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
NCT01825798, Phase 3, Completed, Holland Bloorview Kids Rehabilitation Hospital; results first posted 2018-02-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD). Trials, record NCT01825798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01825798
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
- NCT number
- NCT01825798
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Conditions
- Overweight, Autism Spectrum Disorder
- Interventions
- Metformin, Placebo
- First posted
- 2013-04-08
- Last updated
- 2025-07-16
- Results first posted
- 2018-02-22
- Limitations and caveats
Treatment length doesn't capture metabolic benefits. Unable to evaluate maintenance of initial improvements. Limited information on length of overall exposure to antipsychotic medications. No evaluation on benefit of lifestyle.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Mass Index Z-score | Baseline, 16 Weeks | |
| Secondary | Changes in Additional Body Composition Parameters (Absolute Change in Weight) | Baseline, 16 Weeks | |
| Secondary | Changes in Additional Body Composition Parameters (Relative Change in Weight) | Baseline, 16 Weeks | |
| Secondary | Changes in Additional Body Composition Parameters (Absolute BMI) | Baseline, 16 Weeks | |
| Secondary | Changes in Additional Body Composition Parameters (Abdominal Circumference) | Baseline, 16 Weeks | |
| Secondary | Changes in Additional Body Composition Parameters (Hip Circumference) | Baseline, 16 Weeks | |
| Secondary | Changes in Fasting Metabolic Parameters (Total Cholesterol) | Baseline, 16 Weeks | |
| Secondary | Changes in Fasting Metabolic Parameters (LDL) | Baseline, 16 Weeks | |
| Secondary | Changes in Fasting Metabolic Parameters (HDL) | Baseline, 16 Weeks | |
| Secondary | Changes in Fasting Metabolic Parameters (Triglycerides) | Baseline, 16 Weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Body Mass Index Z-score | Baseline, 16 Weeks | 16-wk change in BMI z-score | MEAN | |
| SECONDARY | Changes in Additional Body Composition Parameters (Absolute Change in Weight) | Baseline, 16 Weeks | 16-wk change in weight (kg) | MEAN | |
| SECONDARY | Changes in Additional Body Composition Parameters (Relative Change in Weight) | Baseline, 16 Weeks | 16-wk change in weight (z-score) | MEAN | |
| SECONDARY | Changes in Additional Body Composition Parameters (Absolute BMI) | Baseline, 16 Weeks | 16-wk change in BMI (kg/m2) | MEAN | |
| SECONDARY | Changes in Additional Body Composition Parameters (Abdominal Circumference) | Baseline, 16 Weeks | centimetres | MEAN | |
| SECONDARY | Changes in Additional Body Composition Parameters (Hip Circumference) | Baseline, 16 Weeks | centimetres | MEAN | |
| SECONDARY | Changes in Fasting Metabolic Parameters (Total Cholesterol) | Baseline, 16 Weeks | 16-week change total cholesterol (mg/dL) | MEAN | |
| SECONDARY | Changes in Fasting Metabolic Parameters (LDL) | Baseline, 16 Weeks | 16-week change in LDL (mg/dL) | MEAN | |
| SECONDARY | Changes in Fasting Metabolic Parameters (HDL) | Baseline, 16 Weeks | 16-week change in HDL (mg/dL) | MEAN | |
| SECONDARY | Changes in Fasting Metabolic Parameters (Triglycerides) | Baseline, 16 Weeks | 16-week change in triglycerides (mg/dL) | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Body Mass Index Z-score | Placebo Hydrochloride Oral Solution | 0.02 | 95% Confidence Interval -0.03 to 0.06 | 16-wk change in BMI z-score | |
| Change in Body Mass Index Z-score | Metformin | -0.08 | 95% Confidence Interval -0.13 to -0.04 | 16-wk change in BMI z-score | |
| Changes in Additional Body Composition Parameters (Absolute Change in Weight) | Placebo Hydrochloride Oral Solution | 2.80 | 95% Confidence Interval 1.90 to 3.70 | 16-wk change in weight (kg) | |
| Changes in Additional Body Composition Parameters (Absolute Change in Weight) | Metformin | 0.07 | 95% Confidence Interval -0.88 to 1.02 | 16-wk change in weight (kg) | |
| Changes in Additional Body Composition Parameters (Relative Change in Weight) | Placebo Hydrochloride Oral Solution | 0.04 | 95% Confidence Interval -0.01 to 0.08 | 16-wk change in weight (z-score) | |
| Changes in Additional Body Composition Parameters (Relative Change in Weight) | Metformin | -0.10 | 95% Confidence Interval -0.15 to -0.05 | 16-wk change in weight (z-score) | |
| Changes in Additional Body Composition Parameters (Absolute BMI) | Placebo Hydrochloride Oral Solution | 0.52 | 95% Confidence Interval 0.18 to 0.87 | 16-wk change in BMI (kg/m2) | |
| Changes in Additional Body Composition Parameters (Absolute BMI) | Metformin | -0.43 | 95% Confidence Interval -0.80 to -0.06 | 16-wk change in BMI (kg/m2) | |
| Changes in Additional Body Composition Parameters (Abdominal Circumference) | Placebo Hydrochloride Oral Solution | 1.45 | 95% Confidence Interval 0.39 to 2.51 | centimetres | |
| Changes in Additional Body Composition Parameters (Abdominal Circumference) | Metformin | -0.21 | 95% Confidence Interval -1.32 to 0.91 | centimetres |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Hydrochloride Oral Solution | 32 | |
| Overall Study | STARTED | Metformin | 28 | |
| Overall Study | COMPLETED | Placebo Hydrochloride Oral Solution | 30 | |
| Overall Study | COMPLETED | Metformin | 23 | |
| Overall Study | NOT COMPLETED | Placebo Hydrochloride Oral Solution | 2 | |
| Overall Study | NOT COMPLETED | Metformin | 5 |
Source ClinicalTrials.gov
Adverse events108
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 | Overall | Ear and labyrinth disorders | Placebo Hydrochloride Oral Solution | 3 | 32 | 4 |
| other | Overall | Ear and labyrinth disorders | Metformin | 0 | 28 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo Hydrochloride Oral Solution | 3 | 32 | 4 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Metformin | 2 | 28 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo Hydrochloride Oral Solution | 3 | 32 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | Metformin | 3 | 28 | 3 |
| other | Abdominal Pain, upper | Gastrointestinal disorders | Placebo Hydrochloride Oral Solution | 4 | 32 | 4 |
| other | Abdominal Pain, upper | Gastrointestinal disorders | Metformin | 3 | 28 | 3 |
| other | Abnormal Feces | Gastrointestinal disorders | Placebo Hydrochloride Oral Solution | 0 | 32 | 0 |
| other | Abnormal Feces | Gastrointestinal disorders | Metformin | 3 | 28 | 3 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Hydrochloride Oral Solution | ||
| Total, all-cause mortality | Metformin | ||
| Total, other adverse events | Placebo Hydrochloride Oral Solution | 32 | 32 |
| Total, other adverse events | Metformin | 28 | 28 |
| Total, serious adverse events | Placebo Hydrochloride Oral Solution | 1 | 32 |
| Total, serious adverse events | Metformin | 0 | 28 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Metformin vs Placebo Hydrochloride Oral Solution: serious adverse events |
Source 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/NCT01825798
GET https://conductscience.org/api/trials/v1/NCT01825798/results?page=2