Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration: A multicentric, double-blind, placebo-controlled trial

Baptista, Trino; Rangel, Nairy; Fernández, Virginia; Carrizo, Edgardo; El Fakih, Yamily; Uzcátegui, Euderruh; Galeazzi, Tatiana; Gutiérrez, María A.; Servigna, Mercedes; Dávila, Adriana; Uzcátegui, Marycelvia; Serrano, Ana; Connell, Lisette; Beaulieu, Serge; de Baptista, Enma Araujo

doi:10.1016/j.schres.2007.03.029

« Previous Next »Schizophrenia Research
Volume 93, Issue 1 , Pages 99-108, July 2007

Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration: A multicentric, double-blind, placebo-controlled trial

Trino Baptista
- Department of Physiology, Los Andes University Medical School, PO Box 93, Mérida, 5101-A, Venezuela
- Corresponding author. Tel.: +58 416 676 0320.
Nairy Rangel
- Psychiatric Institute “Dr. Raúl Castillo”, Peribeca, San Cristóbal, Táchira State, Venezuela
Virginia Fernández
- Institute of Clinical Research “Dr. Américo Negrette”, Zulia University Medical School, Maracaibo, Venezuela
Edgardo Carrizo
- Institute of Clinical Research “Dr. Américo Negrette”, Zulia University Medical School, Maracaibo, Venezuela
Yamily El Fakih
- Department of Psychiatry, Los Andes University Medical School, Mérida, Venezuela
Euderruh Uzcátegui
- Department of Psychiatry, Los Andes University Medical School, Mérida, Venezuela
Tatiana Galeazzi
- LABIMET, Los Andes University Medical School, San Cristóbal, Venezuela
María A. Gutiérrez
- CATESFAM, Maracaibo, Venezuela
Mercedes Servigna
- CATESFAM, Maracaibo, Venezuela
Adriana Dávila
- Psychiatric Institute “Dr. Raúl Castillo”, Peribeca, San Cristóbal, Táchira State, Venezuela
Marycelvia Uzcátegui
- Department of Psychiatry, Los Andes University Medical School, Mérida, Venezuela
Ana Serrano
- Department of Psychiatry, Los Andes University Medical School, Mérida, Venezuela
Lisette Connell
- Institute of Clinical Research “Dr. Américo Negrette”, Zulia University Medical School, Maracaibo, Venezuela
Serge Beaulieu
- Douglas Hospital Research Center, McGill University, Montreal, QC, Canada
Enma Araujo de Baptista
- Pharmacy School, Department of Microbiology, Los Andes University Medical School, Mérida, Venezuela

Received 11 February 2007; received in revised form 20 March 2007; accepted 21 March 2007. published online 11 May 2007.

Abstract

Background

Excessive body weight gain (BWG) is a clinically relevant side effect of olanzapine administration. The primary objective of this study was to assess whether metformin prevents or reverses BWG in patients with schizophrenia or bipolar disorder under olanzapine administration. Secondarily we evaluated diverse metabolic variables.

Methods

Eighty patients taking olanzapine (5–20 mg daily for more than 4 consecutive months) were randomly allocated to metformin (n=40; 850 to 2550 mg daily) or placebo (n=40) group in a 12-week double-blind protocol. Waist circumference (WC) body weight (BW), body mass index (BMI) fasting glucose, glycated hemoglobin (Hb1c), insulin, an insulin resistance index (HOMA-IR) lipids, leptin, c-reactive protein, fibrinogen, cortisol and the growth hormone (GH) were evaluated at baseline and at week 12 of treatment.

Results

The metformin group lost 1.4±3.2 kg (p=0.01) and tended to decrease its leptin levels, whereas the placebo group maintained a stable weight: −0.18±2.8 kg (p=0.7). The HOMA-IR significantly increased after placebo (p=0.006) and did not change after metformin (p=0.8). No ostensible differences were observed in the other variables, even though metformin did not improve the lipid profile and the Hb1c levels.