Study protocol of a randomized, double-blind, placebo-controlled, multi-center trial to treat antipsychotic-induced weight gain: the Metformin-Lifestyle in antipsychotic users (MELIA) trial
de Boer N, Guloksuz S, van Baal C, Willebrands L, Deenik J, Vinkers C, Rossum I, Zinkstok J, Wilting I, Zantvoord J, Backx F, Swildens W, Schouw M, Bogers J, Hulshof F, de Knijff R, Duindam P, Veereschild M, Bak M, Frederix G, de Haan L, van Os J, Cahn W, Luykx J. Study protocol of a randomized, double-blind, placebo-controlled, multi-center trial to treat antipsychotic-induced weight gain: the Metformin-Lifestyle in antipsychotic users (MELIA) trial. BMC Psychiatry 2021, 21: 4. PMID: 33402159, PMCID: PMC7783702, DOI: 10.1186/s12888-020-02992-4.Peer-Reviewed Original ResearchMeSH KeywordsAntipsychotic AgentsDouble-Blind MethodHumansLife StyleMeliaMetforminMulticenter Studies as TopicNetherlandsQuality of LifeRandomized Controlled Trials as TopicWeight GainConceptsNetherlands Trial RegisterLifestyle interventionQuality of lifeTreatment inceptionOutcome measuresWeight gainAntipsychotic-induced weight gainSafety of metforminUse of metforminCommon adverse effectsSecondary outcome measuresPrimary outcome measureWeeks of treatmentBody weight lossMulti-center trialType 2 diabetesMajor health problemYears of ageSchizophrenia spectrum disordersTrials RegisterMetabolic syndromeOptimal management strategyExercise programMetformin treatmentDietary consultation