2021
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 ResearchConceptsNetherlands 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
2013
Investigating the safety and efficacy of naltrexone for anti-psychotic induced weight gain in severe mental illness: study protocol of a double-blind, randomized, placebo-controlled trial
Tek C, Guloksuz S, Srihari VH, Reutenauer EL. Investigating the safety and efficacy of naltrexone for anti-psychotic induced weight gain in severe mental illness: study protocol of a double-blind, randomized, placebo-controlled trial. BMC Psychiatry 2013, 13: 176. PMID: 23805859, PMCID: PMC3702521, DOI: 10.1186/1471-244x-13-176.Peer-Reviewed Original ResearchConceptsSevere mental illnessEfficacy of naltrexoneWeight gainOutcome measurementsHealth problemsMental illnessGreater New Haven areaTumor necrosis factor alphaWeight lossCurrent available medicationsPlacebo-controlled trialHigh-sensitivity CRPOpioid receptor antagonistSecondary outcome measuresSerum lipid profilePrimary outcome measurementBody mass indexD2 receptor blockadeEffects of naltrexoneNovel pharmacological optionsNecrosis factor alphaDoses of naltrexoneMajor health problemRates of obesitySignificant weight loss