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
Autor: | Jeroen Deenik, Maarten Bak, Nini de Boer, Frank J G Backx, Jasper B. Zantvoord, Ingeborg Wilting, Mike Veereschild, Leonie Willebrands, Peter Duindam, W. Swildens, Caroline van Baal, Geert W.J. Frederix, Rudolf de Knijff, Jurjen J. Luykx, Jim van Os, M.L.J. Schouw, Janneke Zinkstok, Wiepke Cahn, Jan P.A.M. Bogers, Sinan Guloksuz, Folkwin Hulshof, Inge Winter van Rossum, Christiaan H. Vinkers, Lieuwe de Haan |
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Přispěvatelé: | Psychiatrie & Neuropsychologie, RS: MHeNs - R2 - Mental Health, MUMC+: MA Psychiatrie (3), MUMC+: Hersen en Zenuw Centrum (3), Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep, Psychiatry, APH - Mental Health, Graduate School, Adult Psychiatry, Child Psychiatry, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Amsterdam Neuroscience - Compulsivity, Impulsivity & Attention, Amsterdam Neuroscience, Amsterdam Neuroscience - Complex Trait Genetics |
Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
medicine.medical_specialty
lifestyle lcsh:RC435-571 medicine.medical_treatment Psychological intervention QUESTIONNAIRE ORGANIZATION Overweight Placebo Weight Gain Study Protocol Quality of life Double-Blind Method Weight loss Internal medicine lcsh:Psychiatry medicine Humans Multicenter Studies as Topic Antipsychotic Life Style Netherlands Randomized Controlled Trials as Topic METABOLIC SYNDROME RISK antipsychotic-induced weight gain (aiwg) INSTRUMENT business.industry SEVERE MENTAL-ILLNESS Metformin schizophrenia Psychiatry and Mental health INDIVIDUALS PHYSICAL-ACTIVITY Quality of Life Melia medicine.symptom CLOZAPINE business Body mass index INTERVENTION medicine.drug chizophrenia Antipsychotic Agents |
Zdroj: | BMC Psychiatry, 21(1):4. BioMed Central Ltd BMC Psychiatry, 21(1):4. BioMed Central BMC Psychiatry de Boer, N, Guloksuz, S, van Baal, C, Willebrands, L, Deenik, J, Vinkers, C H, Rossum, I W V, Zinkstok, J, Wilting, I, Zantvoord, J B, Backx, F, Swildens, W E, 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 J 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 ', BMC Psychiatry, vol. 21, no. 1, 4 . https://doi.org/10.1186/s12888-020-02992-4 BMC psychiatry, 21(1):4. BioMed Central BMC Psychiatry, Vol 21, Iss 1, Pp 1-11 (2021) |
ISSN: | 1471-244X |
Popis: | Background Antipsychotic-induced Weight Gain (AiWG) is a debilitating and common adverse effect of antipsychotics. AiWG negatively impacts life expectancy, quality of life, treatment adherence, likelihood of developing type-2 diabetes and readmission. Treatment of AiWG is currently challenging, and there is no consensus on the optimal management strategy. In this study, we aim to evaluate the use of metformin for the treatment of AiWG by comparing metformin with placebo in those receiving treatment as usual, which includes a lifestyle intervention. Methods In this randomized, double-blind, multicenter, placebo-controlled, pragmatic trial with a follow-up of 52 weeks, we aim to include 256 overweight participants (Body Mass Index (BMI) > 25 kg/m2) of at least 16 years of age. Patients are eligible if they have been diagnosed with schizophrenia spectrum disorder and if they have been using an antipsychotic for at least three months. Participants will be randomized with a 1:1 allocation to placebo or metformin, and will be treated for a total of 26 weeks. Metformin will be started at 500 mg b.i.d. and escalated to 1000 mg b.i.d. 2 weeks thereafter (up to a maximum of 2000 mg daily). In addition, all participants will undergo a lifestyle intervention as part of the usual treatment consisting of a combination of an exercise program and dietary consultations. The primary outcome measure is difference in body weight as a continuous trait between the two arms from treatment inception until 26 weeks of treatment, compared to baseline. Secondary outcome measures include: 1) Any element of metabolic syndrome (MetS); 2) Response, defined as ≥5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General mental and physical health; and 5) Cost-effectiveness. Finally, we aim to assess whether genetic liability to BMI and MetS may help estimate the amount of weight reduction following initiation of metformin treatment. Discussion The pragmatic design of the current trial allows for a comparison of the efficacy and safety of metformin in combination with a lifestyle intervention in the treatment of AiWG, facilitating the development of guidelines on the interventions for this major health problem. Trial registration This trial was registered in the Netherlands Trial Register (NTR) at https://www.trialregister.nl/trial/8440 as NTR NL8840 on March 8, 2020. |
Databáze: | OpenAIRE |
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