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

NCT00451399 | Completed Phase 4 DMC

• 1 other identifier: Jzhao
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain

Keywords

Weight gain; antipsychotic; lifestyle interventions; metformin; antipsychotic-induced weight gain.

Outcome Measures

Primary Outcomes (1)

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

Interventions

metformin DRUG

lifestyle intervention BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Institute of Mental Health of The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

Related Publications (2)

• Kang D, Jing Z, Li R, Hei G, Shao T, Li L, Sun M, Yang Y, Wang Y, Wang X, Long Y, Huang X, Wu R. Effect of Betahistine and Metformin on Antipsychotic-Induced Weight Gain: An Analysis of Two Clinical Trials. Front Psychiatry. 2018 Nov 27;9:620. doi: 10.3389/fpsyt.2018.00620. eCollection 2018.

  PMID: 30542300 DERIVED

• Wu RR, Zhao JP, Jin H, Shao P, Fang MS, Guo XF, He YQ, Liu YJ, Chen JD, Li LH. Lifestyle intervention and metformin for treatment of antipsychotic-induced weight gain: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):185-93. doi: 10.1001/jama.2007.56-b.

  PMID: 18182600 DERIVED

MeSH Terms

Conditions

Weight Gain

Interventions

Metformin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jingping Zhao, MD

  Second Xiangya Hospital of Central South University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 23, 2007
• Study Start: October 1, 2004
• Study Completion: December 1, 2006
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

CN (1)