A clinical trial to study the effects of metformin in prevention of olanzapine induced weight gain, type 2 diabetes mellitus and lipid abnormalities in patients with schizophrenia.

EFFICACY OF METFORMIN IN PREVENTING OLANZAPINE INDUCED METABOLIC ABNORMALITIES IN SCHIZOPHRENIC PATIENTS â?? A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/05/003685

Enrollment

Registered

2013-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- schizophrenia, obesity, hyperglycemia, insulin resistance and hypertriglyceridemia

Interventions

Intervention1: Metformin 500mg orally, Olanzapine 5-20mg orally: Metformin 500mg orally along with Olanzapine 5-20mg orally for 12 weeks Control Intervention1: Placebo, Olanzapine 5-20mg orally: Place

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex aged between 18 and 65 years suffering from first episode schizophrenia as diagnosed by the Diagnostic and Statistical Manual of Mental disorders IV (DSM IV) criteria.

Exclusion criteria

Exclusion criteria: a. Patients with pre-existing obesity. (Body mass index >30kg/m2 and/or waist circumference >= 90cm and >=80cm in males and females respectively). b. Patients with a known diagnosis of type 1 or type 2 diabetes mellitus. c. Patients suffering from anorexia nervosa, bulimia nervosa or neoplastic disease. d. Patients with a history of alcohol dependence. e. Patients suffering from any major endocrine disorder. f. Patient on treatment for any major medical or surgical illness. g. Pregnant and lactating women. h. Non complying patients.

Design outcomes

Primary

Measure	Time frame
Change in weight at the end of 12 weeks as measured by a. weight in kilogram (kg). b. waist circumference measured in centimeter (cm) and c. the body mass index measured by dividing the weight in kg by the square of height (m2). Timepoint: 12 weeks	—

Secondary

Measure	Time frame
a. Hyperglycemia - Fasting blood glucose level of â?¥ 100mg% b. Hypertriglyceridemia-Fasting triglyceride level of â?¥ 150mg%. c. Insulin resistance: Ratio of serum triglycerides to serum high density lipoprotein cholesterol (HDL) cholesterol â?¥ 3. Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Urmila Anil Kagal

KLE Universitys J N Medical College, Belgaum

urmilakagal@gmail.com09886888517

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026