Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain - Tabular View

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Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain

This study has been completed.
Information provided by Central South University

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain

Official Title ^†

Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain: a Randomized Double-Blind Placebo- Controlled Comparison

Brief Summary

Lifestyle intervention and certain medications have been shown to be effective for antipsychotic-induced weight gain, but no controlled studies have compared psychological and pharmacological therapies. We conducted a randomized, placebo-controlled study to test the efficacy of lifestyle intervention and metformin alone and in combination for antipsychotic-induced weight gain.

Detailed Description

The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.128 patients were randomized to one of four 12-week individual treatments: metformin (750mg/day), placebo, lifestyle intervention plus metformin (750mg/day) or lifestyle intervention plus placebo. Medications were provided in double-blind fashion.The assessments include body weight, body mass index, waist circumference, fasting glucose, fasting insulin and insulin resistance index.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary Outcome Measure ^†

body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index

Secondary Outcome Measure ^†

Condition ^†

Weight Gain

Intervention ^†

Drug: metformin
Behavioral: lifestyle intervention

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

128

Start Date ^†

October 2004

Completion Date

December 2006

Eligibility Criteria ^†

Inclusion Criteria:

All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia27.
Participants were required to get weight gain more than 10% of their predrug body weight during less than 12 months of treatment with a targeted antipsychotic agent- clozapine, olanzapine, risperidone or sulpiride.
The duration of illness for all participants was less than 12 months.
Participants could be taking only one antipsychotic, whose dose had not changed by changed by more than 25% over the past 3 months.
All patients were stable outpatient.
The total score of Positive and Negative Syndrome Scale (PANSS) for all patients could be ≤60.
All participants were ensured that they could be carefully taken care of by one of their parents or guardians during the trial.

Exclusion Criteria:

Participants were excluded from the study if they had evidence of liver or renal diseases, pregnant or lactating women, cardiovascular diseases, hypertension or diabetes mellitus, specific systemic diseases, or conditions that limited their ability to perform the lifestyle modifications, such as arthritis, pulmonary diseases, neurological or dietary restrictions.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

China

Administrative Information Fields

NCT ID ^†

NCT00451399

Organization ID

Jzhao

Secondary IDs ^††

Study Sponsor ^†

Central South University

Collaborators ^††

Investigators ^†

Study Director:

Jingping Zhao, MD

Central South University

Information Provided By

Central South University

Verification Date

October 2007

First Received Date ^†

March 22, 2007

Last Updated Date

October 30, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.