Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-05 @ 8:01 PM
Study NCT ID:
NCT01541605
Status:
COMPLETED
Last Update Posted:
2016-06-10
First Post:
2012-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylphenidate for the Treatment of Acute Mania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Portugal']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-09', 'studyFirstSubmitDate': '2012-02-16', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'manic symptoms as assessed by the Young Mania Rating Scale (YMRS)', 'timeFrame': 'after 2.5 days of treatment'}], 'secondaryOutcomes': [{'measure': 'EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)', 'timeFrame': 'after 2.5 days of treatment'}, {'measure': 'movements as assessed by actimetry', 'timeFrame': 'after 2.5 days of treatment'}, {'measure': 'cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)', 'timeFrame': 'after 2.5 days of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mania']}, 'referencesModule': {'references': [{'pmid': '23446109', 'type': 'BACKGROUND', 'citation': 'Kluge M, Hegerl U, Sander C, Dietzel J, Mergl R, Bitter I, Demyttenaere K, Gusmao R, Gonzalez-Pinto A, Perez-Sola V, Vieta E, Juckel G, Zimmermann US, Bauer M, Sienaert P, Quintao S, Edel MA, Bolyos C, Ayuso-Mateos JL, Lopez-Garcia P. Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate. BMC Psychiatry. 2013 Feb 27;13:71. doi: 10.1186/1471-244X-13-71.'}, {'pmid': '29174864', 'type': 'DERIVED', 'citation': 'Hegerl U, Mergl R, Sander C, Dietzel J, Bitter I, Demyttenaere K, Gusmao R, Gonzalez-Pinto A, Zorrilla I, Alocen AG, Sola VP, Vieta E, Juckel G, Zimmermann US, Bauer M, Sienaert P, Quintao S, Edel MA, Bolyos C, Ayuso-Mateos JL, Lopez-Garcia P, Kluge M. A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study). Eur Neuropsychopharmacol. 2018 Jan;28(1):185-194. doi: 10.1016/j.euroneuro.2017.11.003. Epub 2017 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'This study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.', 'detailedDescription': 'Mania can be regarded as an autoregulatory mechanism to enhance unstable vigilance. There is increasing evidence that psychostimulants that increase vigilance may be effective in treating mania. However, controlled studies are lacking.\n\nThis is a two-arm, randomised, placebo-controlled, double-blind, parallel, multi-centre phase IIIb exploratory study to evaluate the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Inpatients\n2. Written informed consent by patients who are competent to consent to study participation.\n3. Diagnosis: manic episode according to the International Classification of Diseases 10th Revision (ICD-10): F30.0, F30.1, F31.0 or F31.1\n4. Male or female of at least 18 years of age\n5. YMRS total score ≥ 20 and ≤ 45 points\n6. Body mass index (BMI) \\> 17\n7. Patients must be able to swallow tablets (study drug).\n\nExclusion Criteria:\n\n1. Any other current major psychiatric ICD-10 disorder is an exclusion criterion except for the following F90, F17.1, F17.2, F40-F59, F60-F69\n2. Contraindications for treatment with methylphenidate except as noted otherwise\n3. Serious non-psychiatric disease, that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator\n4. Oral administration of monoaminooxidase (MAO)-inhibitors within two weeks, fluoxetine within 6 weeks and of any other antidepressant or primarily psychotropic substance except for those specified below within one week before study entry.\n5. Stable treatment with mood stabilisers including lithium, anticonvulsants (e.g. valproate, carbamazepine) or antipsychotics (e.g. risperidone, olanzapine) or benzodiazepines is NOT an exclusion criterion and will be continued; however, patients receiving more than 2 of these substances are NOT eligible for inclusion\n6. Medical history of other disorders of CNS including tics or dyskinesia\n7. Medical history of cardiovascular diseases, severe hypertension, glaucoma, hyperfunction of the thyroid\n8. Patients with congenital or acquired long QT syndrome, or with a familiy history of QT prolongation, sudden cardiac death or other significant inherited cardiac disorders (e.g. family history of hypertrophic cardiomyopathy).\n9. History of Electroconvulsive therapy within the last 3 month\n10. Known alcohol and drug addiction or abuse, except for patients with abstinence \\> 3 month. Patients with sporadic abuse of cannabis (products) will not be excluded from the study. That is even true with a positive Tetrahydrocannabinol (THC) screen in urine.\n11. Pregnant or nursing woman\n12. Concomitant participation in other clinical trials or participation during the 30 days prior to screening\n13. Prior participation in this study\n14. Suicidality'}, 'identificationModule': {'nctId': 'NCT01541605', 'briefTitle': 'Methylphenidate for the Treatment of Acute Mania', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate', 'orgStudyIdInfo': {'id': 'MEMAP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'methylphenidate', 'interventionNames': ['Drug: methylphenidate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'methylphenidate', 'type': 'DRUG', 'description': 'tablets for oral use', 'armGroupLabels': ['methylphenidate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'tablets for oral use', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3070', 'city': 'Kortenberg', 'country': 'Belgium', 'facility': 'Katholieke Universiteit Leuven, campus Kortenberg', 'geoPoint': {'lat': 50.88982, 'lon': 4.54353}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Universität Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Universität Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universität Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '8025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario la Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '01004', 'city': 'Vitoria-Gasteiz', 'country': 'Spain', 'facility': 'Hospital Santiago Apóstol', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'overallOfficials': [{'name': 'Ulrich Hegerl, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Kluge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Clinical Research Network - SCReN', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Psychiatrist', 'investigatorFullName': 'Michael Kluge', 'investigatorAffiliation': 'University of Leipzig'}}}}