The MEtformin-LIfestyle in Antipsychotic users trial

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20221

Enrollment

256

Registered

2020-03-08

Start date

2021-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Schizofrenia, Psychosis, Antipsychotic Use

Interventions

Metformin or placebo started at 2dd500mg and then increased to 2dd1000mg after two weeks.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Difference in weight gain	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactNini de Boer

UMC Utrecht

n.m.deboer-6@umcutrecht.nl088-7567412

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)