Benefit of metformin for weight control and related parameters in obese patients of schizophrenia

Not Applicable

Conditions: Health Condition 1: E65-E68- Overweight, obesity and other hyperalimentationHealth Condition 2: F20-F29- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders

Registration Number: CTRI/2023/09/057609

Lead Sponsor: Government Medical College and Hospital Chandigarh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Patients with a diagnosis of ‘Schizophrenia spectrum and other psychotic disorders’ as per Diagnostic and Statistical Manual-5(DSM-5).

2)Patients having the capacity (as per section 4 of Mental Healthcare Act 2017) to give written consent or Nominated Representative (NR)agreeing to give written consent when the patient does not have adequate capacity.

3)Patients meeting diagnostic criteria for obesity which is specified as Body Mass Index (BMI) of more than 25kg/m² (Consensus statement for Asian Indian guidelines).

4)Patients on second generation antipsychotics for a minimum duration of 6 months.

5)Age group 18-65 years

6)Any gender

7)Patients able to carry out their normal physical activities

Exclusion Criteria

1)Patients with active substance use disorder within the past 6 months (in terms of fulfilling the ICD-11 criteria for substance dependence) except caffeine and nicotine.

2)Patients with any acute medical or surgical illness -Diabetes mellitus, impaired renal function, hepatic disease, cardiovascular disorder, thyroid disorder.

3)Pregnant and lactating patient.

4)Actively suicidal patients or those having high suicide risk currently.

5)Patients with eating disorders

6)Bedridden patients

7)Current or previous treatment with metformin, or history of hypersensitivity to metformin.

8)Current or previous treatment with insulin or any other hypoglycaemic agent

9)Use of any prescription for weight loss prior to study

10)Patients with history of weight loss in last 6 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of metformin on weight and body mass index of obese patients with schizophrenia spectrum and other psychotic disorders on second generation antipsychotics.Timepoint: 0,2,4,8,12 weeks

Secondary Outcome Measures

Name	Time	Method
To assess the effect of metformin on other metabolic parameters – changes in waist and hip circumference, effect on fasting blood sugar levels and lipid profile. <br/ ><br>To assess the tolerability of metformin. <br/ ><br>Timepoint: 0,2,4,8,12 weeks