The MEtformin-LIfestyle in Antipsychotic users trial

• Conditions: Schizofrenia, Psychosis, Antipsychotic Use

• Registration Number: NL-OMON20221
• Lead Sponsor: J. Luykx, W. Cahn, UMC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 256

Inclusion Criteria

Diagnosis of schizophrenia spectrum disorders according to DSM-IV-TR or DSM-5 criteria;
- Antipsychotic use for at least 3 months;
- Willingness to undergo lifestyle interventions;
- Dutch speaking and reading;
- Mentally competent;
- At least 16 years of age;
- Overweight (BMI >25).

Exclusion Criteria

- Suffer from neurodegenerative extrapyramidal disease;
- Carry metformin-related contra-indications, i.e.: conditions predisposing to tissue hypoxia (such as congestive heart failure, recent myocardial infarction and respiratory failure), metabolic acidosis, precoma diabeticum, kidney failure (GFR<30ml/min) and conditions predisposing to kidney failure, disorders in the use of alcohol and liver failure;
- Use of one or more of the following medication(s):
NSAIDs
ACE-inhibitors
ARBs (angiotensin receptor blockers)
diuretics
OCT (organic cation transporters) -1 and 2 inhibitors (e.g. cimetidine, dolutegravir, isavuconazol, trimethoprim, vandetanib, crizotinibib, vandetanib, and verapamil) and inductors (e.g. rifampicin);
- Suffer from vitamin B12 deficiency;
- Suffer from diabetes mellitus;
- Pregnant or breast feeding women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in weight gain

Secondary Outcome Measures

Name	Time	Method
Subgroup analysis clozapine versus other antipsychotic use and differences between treatment inception and 26 weeks of treatment in: 1) All other elements of metabolic syndrome; 2) A measure of response, defined as =5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General psychological and physical health; and 5) Cost-effectiveness. Safety outcomes include adverse drug reactions. At last, we aim to assess whether genetic liability to BMI and metabolic syndrome may help estimate weight reduction following initiation of metformin treatment as tertiary outcome.