Evidence mapPaperPMID 33402159Full record

ArticleBMC psychiatry2021

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.

Nini de Boer, Sinan Guloksuz, Caroline van Baal, Leonie Willebrands, Jeroen Deenik, Christiaan H Vinkers, Inge Winter-van Rossum, Janneke Zinkstok, Ingeborg Wilting, Jasper B Zantvoord and 14 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 7 institutions in 3 countries.

Nini de BoerDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, HP A01.126, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands. N.M.deBoer-6@umcutrecht.nl.ORCID 0000-0002-4956-3555
Sinan GuloksuzDepartment of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre, Maastricht, The Netherlands.
Caroline van BaalDepartment of Biostatistics and Research Support, Julius Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Leonie WillebrandsDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, HP A01.126, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands.
Jeroen DeenikDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, HP A01.126, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands.
Christiaan H VinkersDepartment of Psychiatry and Department of Anatomy and Neuroscience, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Inge Winter-van RossumDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, HP A01.126, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands.
Janneke ZinkstokDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, HP A01.126, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands.
Ingeborg WiltingDepartment of Clinical Pharmacy, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Jasper B ZantvoordDepartment of Psychiatry and Department of Anatomy and Neuroscience, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Frank BackxDepartment of Rehabilitation, Physiotherapy Science & Sport, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Wilma E SwildensAltrecht Mental Health Care Institute, Utrecht, The Netherlands.
Marieke SchouwAltrecht Mental Health Care Institute, Utrecht, The Netherlands.
Jan BogersGGZ Rivierduinen, Oegstgeest, The Netherlands.
Folkwin HulshofGGNet Mental Health, Warnsveld, The Netherlands.
Rudolf de KnijffGGNet Mental Health, Warnsveld, The Netherlands.
Peter DuindamGGNet Mental Health, Warnsveld, The Netherlands.
Mike VeereschildGGNet Mental Health, Warnsveld, The Netherlands.
Maarten BakDepartment of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre, Maastricht, The Netherlands.
Geert FrederixDepartment of Public Health, Julius Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Lieuwe de HaanDepartment of Psychiatry and Department of Anatomy and Neuroscience, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Jim van OsDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, HP A01.126, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands.
Wiepke CahnDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, HP A01.126, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands.
Jurjen J LuykxDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, HP A01.126, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands.
Utrecht University · NLGGNet · NLAmsterdam Neuroscience · NLAltrecht GGZ · NLMaastricht University Medical Centre · NLGGZ Rivierduinen · NLKing's College London · GB

Funding

ZonMw 848083002
6 · The paper itself

Abstract

backgroundAntipsychotic-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.

methodsIn 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/m 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 registrationThis trial was registered in the Netherlands Trial Register (NTR) at  https://www.trialregister.nl/trial/8440 as NTR NL8840 on March 8, 2020.

Indexed as

Antipsychotic AgentsMeliaMetforminDouble-Blind MethodHumansLife StyleMulticenter Studies as TopicNetherlandsPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicWeight GainAntipsychotic AgentsMetforminAntipsychotic-induced weight gain (AiWG)LifestyleMetforminSchizophrenia

Identifiers

PMID33402159
PMCPMC7783702
OpenAlexW3118815940

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.