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

This study has been completed.
Sponsor:
Information provided by:
Central South University
ClinicalTrials.gov Identifier:
NCT00451399
First received: March 22, 2007
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Weight Gain
Drug: metformin
Behavioral: lifestyle intervention
Phase 4

Central South University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain: a Randomized Double-Blind Placebo- Controlled Comparison

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index

Estimated Enrollment: 128
Study Start Date: October 2004
Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451399

Locations
China, Hunan
Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Central South University
Investigators
Study Director: Jingping Zhao, MD Central South University
  More Information

No publications provided by Central South University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00451399     History of Changes
Other Study ID Numbers: Jzhao
Study First Received: March 22, 2007
Last Updated: October 30, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Central South University:
Weight gain
antipsychotic
lifestyle interventions
metformin
antipsychotic-induced weight gain.

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms
Metformin
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 26, 2014