Trial · NCT00806234

Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics

NCT00806234, Phase 4, Completed, Johns Hopkins University; results first posted 2017-04-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics. Trials, record NCT00806234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00806234

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics
NCT number: NCT00806234
Status: Completed
Phases: Phase 4
Enrollment: 127 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Psychotic Disorders
Interventions: Aripiprazole or Perphenazine, Metformin, Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine
First posted: 2008-12-10
Last updated: 2017-04-25
Results first posted: 2017-04-25
Limitations and caveats: 27 subjects were randomized between 10/2009-10/2013 into three groups (CONTROL=47; MET=49; SWITCH=31). Safety analyses excluded 4 participants (CONTROL=1, MET=2, SWITCH=1) who discontinued at baseline.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Body Mass Index (BMI) Z-score Change	Change from baseline to 24 weeks
Secondary	Change in Whole Body Insulin Sensitivity Index	Change from baseline to 24 weeks
Secondary	Triglyceride Levels	Change from baseline to 24 weeks
Secondary	Change in Low Density Lipoprotein (LDL) Cholesterol Level	From Baseline to Week 24

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Body Mass Index (BMI) Z-score Change	Change from baseline to 24 weeks	Z Score	LEAST_SQUARES_MEAN
SECONDARY	Change in Whole Body Insulin Sensitivity Index	Change from baseline to 24 weeks	mU/L	LEAST_SQUARES_MEAN
SECONDARY	Triglyceride Levels	Change from baseline to 24 weeks	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change in Low Density Lipoprotein (LDL) Cholesterol Level	From Baseline to Week 24	mg/dL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Body Mass Index (BMI) Z-score Change	Healthy Lifestyle Information	0.040	Standard Error 0.029	Z Score
Body Mass Index (BMI) Z-score Change	Switch Treatment + Healthy Lifestyle Instruction	-0.112	Standard Error 0.037	Z Score
Body Mass Index (BMI) Z-score Change	Metformin Treatment + Healthy Lifestyle Instruction	-0.088	Standard Error 0.028	Z Score
Change in Whole Body Insulin Sensitivity Index	Healthy Lifestyle Information	0.74	Standard Error 0.82	mU/L
Change in Whole Body Insulin Sensitivity Index	Switch Treatment + Healthy Lifestyle Instruction	0.42	Standard Error 0.91	mU/L
Change in Whole Body Insulin Sensitivity Index	Metformin Treatment + Healthy Lifestyle Instruction	-0.34	Standard Error 0.65	mU/L
Triglyceride Levels	Healthy Lifestyle Information	0.2	Standard Error 9.1	mg/dL
Triglyceride Levels	Switch Treatment + Healthy Lifestyle Instruction	16.6	Standard Error 12.0	mg/dL
Triglyceride Levels	Metformin Treatment + Healthy Lifestyle Instruction	14.7	Standard Error 8.7	mg/dL
Change in Low Density Lipoprotein (LDL) Cholesterol Level	Healthy Lifestyle Information	3.6	Standard Error 4.2	mg/dL

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Healthy Lifestyle Information	47
Overall Study	STARTED	Switch Treatment + Healthy Lifestyle Instruction	31
Overall Study	STARTED	Metformin Treatment + Healthy Lifestyle Instruction	49
Overall Study	COMPLETED	Healthy Lifestyle Information	34
Overall Study	COMPLETED	Switch Treatment + Healthy Lifestyle Instruction	19
Overall Study	COMPLETED	Metformin Treatment + Healthy Lifestyle Instruction	37
Overall Study	NOT COMPLETED	Healthy Lifestyle Information	13
Overall Study	NOT COMPLETED	Switch Treatment + Healthy Lifestyle Instruction	12
Overall Study	NOT COMPLETED	Metformin Treatment + Healthy Lifestyle Instruction	12

Source ClinicalTrials.gov

Adverse events96

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	Abdominal pain or discomfort	Gastrointestinal disorders	Healthy Lifestyle Information	0	45	0
other	Abdominal pain or discomfort	Gastrointestinal disorders	Switch Treatment + Healthy Lifestyle Instruction	0	30	0
other	Abdominal pain or discomfort	Gastrointestinal disorders	Metformin Treatment + Healthy Lifestyle Instruction	5	47	5
other	Agitation	Nervous system disorders	Healthy Lifestyle Information	8	45	8
other	Agitation	Nervous system disorders	Switch Treatment + Healthy Lifestyle Instruction	6	30	6
other	Agitation	Nervous system disorders	Metformin Treatment + Healthy Lifestyle Instruction	5	47	5
other	Hypersomnia	Nervous system disorders	Healthy Lifestyle Information	1	45	1
other	Hypersomnia	Nervous system disorders	Switch Treatment + Healthy Lifestyle Instruction	2	30	2
other	Hypersomnia	Nervous system disorders	Metformin Treatment + Healthy Lifestyle Instruction	1	47	1
other	Aggression or hostility	Psychiatric disorders	Healthy Lifestyle Information	10	45	10

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Healthy Lifestyle Information
Total, all-cause mortality	Switch Treatment + Healthy Lifestyle Instruction
Total, all-cause mortality	Metformin Treatment + Healthy Lifestyle Instruction
Total, other adverse events	Healthy Lifestyle Information	45	45
Total, other adverse events	Switch Treatment + Healthy Lifestyle Instruction	30	30
Total, other adverse events	Metformin Treatment + Healthy Lifestyle Instruction	47	47
Total, serious adverse events	Healthy Lifestyle Information	1	45
Total, serious adverse events	Switch Treatment + Healthy Lifestyle Instruction	5	30
Total, serious adverse events	Metformin Treatment + Healthy Lifestyle Instruction	3	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23947389	BACKGROUND

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01MH080270	1/3-Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT)	RIDDLE, MARK A	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE OF MENTAL HEALTH	2008 to 2012

Source NIH RePORTER

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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00806234

GET https://conductscience.org/api/trials/v1/NCT00806234/events?page=2

API reference For AI assistants