*The MEtformin-LIfestyle in Antipsychotic users trial (MELIA): optimizing the use of metformin in the management of antipsychotic-induced weight gain.*

Phase 3

Recruiting

• Conditions: gewicht; Antipsychotic induced Weight Gain; 10039628

• Registration Number: NL-OMON52718
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

- Diagnosis of schizophrenia spectrum disorders according to DSM-IV-TR or DSM-5
criteria;
- Diagnosis of bipolar disorder according to DSM-IV-TR or DSM-5 criteria;
- Antipsychotic use for at least 3 months (participants may have switched
antipsychotic use in the past 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, liver
failure and disorders in the use of alcohol defined as > 2 reported
consumptions daily and a gGT of over 60U/L or a CDT >2.2% (measured in blood
using the N-Latex CDT method).
- 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 or fertile women refusing contraceptive use.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: We aim to optimize the application of an existing drug,<br /><br>metformin, for a new indication, AiWG, by showing that metformin in<br /><br>combination with lifestyle interventions reduces the AiWG compared to placebo<br /><br>in combination with lifestyle interventions. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective: We aim to investigate the difference in reduction of AiWG<br /><br>between clozapine use versus other antipsychotic use, betweeen patients with<br /><br>schizophrenia and bipolar disorder and the difference between high-risk agents<br /><br>-risperidone, olanzapine, clozapine and quetiapine- vs. all other<br /><br>antipsychotics.<br /><br>In post hoc sensitivity analysis, the quantitative measure of the amount of<br /><br>self-reported AiWG will be used to examine differences between AiWG and weight<br /><br>gain due to other reasons.<br /><br><br /><br><br /><br>Tertiary objective: At last, we aim to assess whether metformin compared to<br /><br>placebo improves metabolic traits, quality of life, general physical and<br /><br>psychological health, cost effectiveness and whether genetic liability to BMI<br /><br>and metabolic syndrome may help estimate weight reduction following initiation<br /><br>of metformin treatment.</p><br>