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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451399
• Other study ID #: Jzhao
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2007
• Last updated: October 30, 2007
• Start date: October 2004
• Est. completion date: December 2006

Study information

• Verified date: October 2007
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-?) 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Weight Gain

Intervention

Drug:
• metformin

Behavioral:
• lifestyle intervention

Locations

Country	Name	City	State
China	Institute of Mental Health of The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index