{"status":"OK","data":{"id":656670,"identifier":"VXUQSZ","persistentUrl":"https://doi.org/10.34894/VXUQSZ","protocol":"doi","authority":"10.34894","separator":"/","publisher":"DataverseNL","publicationDate":"2026-09-21","storageIdentifier":"surf://10.34894/VXUQSZ","effectiveDatasetFileCountLimit":10000,"datasetFileUploadsAvailable":10000,"datasetType":"dataset","locks":[],"latestVersion":{"id":35117,"datasetId":656670,"datasetPersistentId":"doi:10.34894/VXUQSZ","datasetType":"dataset","storageIdentifier":"surf://10.34894/VXUQSZ","versionNumber":1,"internalVersionNumber":10,"versionMinorNumber":0,"versionState":"RELEASED","latestVersionPublishingState":"RELEASED","lastUpdateTime":"2026-09-21T12:13:44Z","releaseTime":"2026-09-21T12:13:44Z","createTime":"2026-07-23T19:08:44Z","publicationDate":"2026-09-21","citationDate":"2026-09-21","effectiveDatasetFileCountLimit":10000,"datasetFileUploadsAvailable":10000,"termsOfUse":"The standard Data Sharing Agreement (DSA) of the UMC Utrecht must be signed without adjustments. This DSA is in compliance with Dutch law. No costs are involved.","confidentialityDeclaration":"No confidentiality declaration needed under the condition that Terms of Use are met.","specialPermissions":"To obtain access to the data, a <a href=\"https://www.umcutrecht.nl/en/data-request-form-umc-utrecht\">request form</a> has to be completed. Only if your request is approved, in addition to a completed request form, a Data Sharing Agreement (DSA) in line with GDPR regulations and/or a Research Collaboration Agreement (RCA) should be signed before data is shared. Only data requests in line with the Terms of Use will be taken into consideration.","restrictions":"Read <a href=\"https://www.umcutrecht.nl/en/research-data-umc-utrecht\">here</a>  for more information about the data request proces and the Data Sharing Agreement. The Data Sharing Agreement is signed by both parties.","citationRequirements":"Read <a href=\"https://www.umcutrecht.nl/en/research-data-umc-utrecht\">here</a>  for more information about the data request proces and the Data Sharing Agreement. The Data Sharing Agreement is signed by both parties.","conditions":"To access and use the dataset please read the Terms of Use and the Terms of Access for Restricted Files.","disclaimer":"Read <a href=\"https://www.umcutrecht.nl/en/research-data-umc-utrecht\">here</a>  for more information about the data request proces and the Data Sharing Agreement. The Data Sharing Agreement is signed by both parties.","termsOfAccess":"By downloading or otherwise accessing the materials, the downloader represents his/her acceptance of the Terms of Use. ","fileAccessRequest":false,"metadataBlocks":{"citation":{"displayName":"Citation Metadata","name":"citation","fields":[{"typeName":"title","multiple":false,"typeClass":"primitive","value":"MELIA: Metformin for antipsychotic-induced weight gain in patients with schizophrenia spectrum or bipolar disorder — a double-blind, placebo-controlled randomised trial"},{"typeName":"alternativeTitle","multiple":true,"typeClass":"primitive","value":["MELIA"]},{"typeName":"otherId","multiple":true,"typeClass":"compound","value":[{"otherIdAgency":{"typeName":"otherIdAgency","multiple":false,"typeClass":"primitive","value":"ZonMW"},"otherIdValue":{"typeName":"otherIdValue","multiple":false,"typeClass":"primitive","value":"848083002"}},{"otherIdAgency":{"typeName":"otherIdAgency","multiple":false,"typeClass":"primitive","value":"METC Utrecht / NedMec"},"otherIdValue":{"typeName":"otherIdValue","multiple":false,"typeClass":"primitive","value":"20-278"}},{"otherIdAgency":{"typeName":"otherIdAgency","multiple":false,"typeClass":"primitive","value":"NTR"},"otherIdValue":{"typeName":"otherIdValue","multiple":false,"typeClass":"primitive","value":"NL8840"}}]},{"typeName":"author","multiple":true,"typeClass":"compound","value":[{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Nini de Boer"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Wiepke Cahn"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Jurjen Luykx"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"Amsterdam UMC"}}]},{"typeName":"datasetContact","multiple":true,"typeClass":"compound","value":[{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"Datamanagement Neurosciences"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"Nini de Boer"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"Wiepke Cahn"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}}]},{"typeName":"dsDescription","multiple":true,"typeClass":"compound","value":[{"dsDescriptionValue":{"typeName":"dsDescriptionValue","multiple":false,"typeClass":"primitive","value":"The MELIA trial assessed the efficacy and safety of metformin, as an add-on to lifestyle interventions, for the treatment of antipsychotic-induced weight gain in people with a schizophrenia spectrum or bipolar disorder.\nThis randomised, double-blind, placebo-controlled trial was conducted in the Netherlands. Eligible participants were aged 18 years or older, had a schizophrenia spectrum or bipolar disorder, a body mass index above 25 kg/m², and had been on antipsychotic treatment for at least three months. Broad inclusion criteria were applied to reflect routine clinical practice. Participants were randomly assigned to metformin, titrated up to 2000 mg per day, or to placebo, for 26 weeks. All participants were offered lifestyle interventions. Recruitment took place between July 2020 and February 2024.\nThe primary outcome was change in body weight from baseline to 26 weeks. Secondary outcomes included cardiometabolic measures (body mass index, waist circumference, blood pressure, heart rate, lipid profile, glucose parameters), psychiatric symptom measures, and safety outcomes including adverse drug reactions. People with lived experience of schizophrenia spectrum disorder or bipolar disorder were involved in the design and conduct of the study.\nThis record describes the MELIA trial dataset. Individual participant data are not included in this version. Pseudonymised participant-level data will be added as a restricted file set in a subsequent version; access conditions are described under Dataset Terms."},"dsDescriptionDate":{"typeName":"dsDescriptionDate","multiple":false,"typeClass":"primitive","value":"2026-07-23"}}]},{"typeName":"subject","multiple":true,"typeClass":"controlledVocabulary","value":["Medicine, Health and Life Sciences"]},{"typeName":"publication","multiple":true,"typeClass":"compound","value":[{"publicationRelationType":{"typeName":"publicationRelationType","multiple":false,"typeClass":"controlledVocabulary","value":"References"},"publicationCitation":{"typeName":"publicationCitation","multiple":false,"typeClass":"primitive","value":"de Boer N, Guloksuz S, van Baal C, Willebrands L, Deenik J, Vinkers CH, Rossum IW, Zinkstok J, Wilting I, Zantvoord JB, Backx F, Swildens WE, 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 JJ. 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 Jan 5;21(1):4. doi: 10.1186/s12888-020-02992-4. PMID: 33402159; PMCID: PMC7783702."}}]},{"typeName":"language","multiple":true,"typeClass":"controlledVocabulary","value":["Dutch","English"]},{"typeName":"producer","multiple":true,"typeClass":"compound","value":[{"producerName":{"typeName":"producerName","multiple":false,"typeClass":"primitive","value":"University Medical Center Utrecht"},"producerAbbreviation":{"typeName":"producerAbbreviation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"},"producerURL":{"typeName":"producerURL","multiple":false,"typeClass":"primitive","value":"https://www.umcutrecht.nl"}}]},{"typeName":"grantNumber","multiple":true,"typeClass":"compound","value":[{"grantNumberAgency":{"typeName":"grantNumberAgency","multiple":false,"typeClass":"primitive","value":"ZonMW"},"grantNumberValue":{"typeName":"grantNumberValue","multiple":false,"typeClass":"primitive","value":"848083002"}}]},{"typeName":"depositor","multiple":false,"typeClass":"primitive","value":"de Boer, Nini"},{"typeName":"dateOfDeposit","multiple":false,"typeClass":"primitive","value":"2026-07-23"},{"typeName":"timePeriodCovered","multiple":true,"typeClass":"compound","value":[{"timePeriodCoveredStart":{"typeName":"timePeriodCoveredStart","multiple":false,"typeClass":"primitive","value":"2020-07-09"},"timePeriodCoveredEnd":{"typeName":"timePeriodCoveredEnd","multiple":false,"typeClass":"primitive","value":"2024-12-02"}}]},{"typeName":"dateOfCollection","multiple":true,"typeClass":"compound","value":[{"dateOfCollectionStart":{"typeName":"dateOfCollectionStart","multiple":false,"typeClass":"primitive","value":"2020-07-09"},"dateOfCollectionEnd":{"typeName":"dateOfCollectionEnd","multiple":false,"typeClass":"primitive","value":"2024-12-02"}}]},{"typeName":"kindOfData","multiple":true,"typeClass":"primitive","value":["Clinical Trial Data","Questionnaire Data","Anthropometric Measurements","Laboratory Measurements"]}]},"dansDataVaultMetadata":{"displayName":"Data Vault Metadata","name":"dansDataVaultMetadata","fields":[{"typeName":"dansDataversePid","multiple":false,"typeClass":"primitive","value":"doi:10.34894/VXUQSZ"},{"typeName":"dansDataversePidVersion","multiple":false,"typeClass":"primitive","value":"1.0"},{"typeName":"dansBagId","multiple":false,"typeClass":"primitive","value":"urn:uuid:38122514-04f4-42fb-b6bd-ff6001e2258b"},{"typeName":"dansNbn","multiple":false,"typeClass":"primitive","value":"urn:nbn:nl:ui:13-66be8aee-d841-4156-83f1-7fc1b1b406c3"}]}},"files":[]}}}