A Randomized, Open Labelled, Single Centered Study of Metformin in Preventing Metabolic Syndrome Associated with Initiation of Atypical Antipsychotic Therapy in Adolescents and Young Adults
Abstract
BACKGROUND:
Schizophrenia is a debilitating brain disorder characterized by a chronic remitting and relapsing course of psychosis that is superimposed on persistent deficit features such as negative symptoms and cognitive dysfunction. Metformin is a member of biguanide class of oral hypoglycemic agents. It has been tried for the prevention of metabolic syndrome associated with the use of atypical antipsychotics.
OBJECTIVE:
The purpose of the study was to evaluate the effectiveness and safety of Metformin along with Risperidone to prevent antipsychotic-induced metabolic syndrome in first episode schizophrenia patients.
METHODS:
A randomized, open labelled, prospective study was conducted in the Department of psychiatry, Tirunelveli Medical College from March 2013 to February 2014. Around 96 patients with 18 to 40 years of age who have been diagnosed with first episode schizophrenia based on DSM - IV criteria and on treatment with T.Risperidone 2 mg twice a day for ≤ 2 months were enrolled for the study. They were randomized into 2 groups. Group1 patients were given T. Risperidone (2 mg twice daily, n=48) and group 2 Patients were given T.Metformin (500 mg twice daily, n=48) along with T.Risperidone for 6 months.
The primary endpoint assessed was the proportion of patients developing metabolic syndrome at the end of 6 months in both the groups. The secondary end points were the changes in body mass index, waist circumference, fasting blood sugar and triglycerides from baseline…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 96 participants or records.
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