Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02926859
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2016-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Recovery in Early Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side effects: weight gain', 'timeFrame': '6, 9 and 12 month', 'description': 'Body Mass Index, abdominal girth'}, {'measure': 'Side effects: Vital Signs', 'timeFrame': '6, 9 and 12 month', 'description': 'heart rate, blood pressure, electrocardiography'}, {'measure': 'Side effects: UKU Side Effect rating scale', 'timeFrame': '6, 9 and 12 month'}, {'measure': 'Side effects: Abnormal Involuntary Movement Scale (AIMS)', 'timeFrame': '6, 9 and 12 month'}, {'measure': 'Side effects: Evaluation of extrapyramidal symptoms (EPS)', 'timeFrame': '6, 9 and 12 month'}, {'measure': 'Side effects: physical and neurological examination', 'timeFrame': '6, 9 and 12 month'}, {'measure': 'Standard blood tests', 'timeFrame': '6, 9 and 12 month'}, {'measure': 'Columbia Suicidality Sverity Rating Scale (C-SSRS)', 'timeFrame': '6, 9 and 12 month'}], 'primaryOutcomes': [{'measure': 'All-cause discontinuation', 'timeFrame': 'within 12 month'}], 'secondaryOutcomes': [{'measure': 'Improvement in Psychopathology assessed by PANSS', 'timeFrame': '6, 9 and 12 month', 'description': 'Positive and Negative Syndrome Scale (PANSS)'}, {'measure': 'Improvement in Psychopathology assessed by CGI', 'timeFrame': '6, 9 and 12 month', 'description': 'Clinical Global Impression (CGI)'}, {'measure': 'Improvement in Psychopathology assessed by BSI-53', 'timeFrame': '6, 9 and 12 month', 'description': 'Brief Symptom Inventory (BSI-53)'}, {'measure': 'Improvement in Psychopathology assessed by FROGS', 'timeFrame': '6, 9 and 12 month', 'description': 'Functional Remission of General Schizophrenia (FROGS)'}, {'measure': 'Changes from baseline in Depression Scale', 'timeFrame': '6, 9 and 12 month', 'description': 'Calgary Depression Scale for Schizophrenia (CDSS)'}, {'measure': 'Improvement in social and occupational functioning assessed by GAF', 'timeFrame': '6, 9 and 12 month', 'description': 'Global Assessment of Functioning (GAF)'}, {'measure': 'Improvement in social and occupational functioning assessed by PSP', 'timeFrame': '6, 9 and 12 month', 'description': 'Personal and Social Performance Scale (PSP)'}, {'measure': 'Improvement in social and occupational functioning assessed by EMA', 'timeFrame': '6, 9 and 12 month', 'description': 'Ecological Momentary Assessment (EMA)'}, {'measure': 'Improvement in Quality of life assessed by WHOQUOL-Bref', 'timeFrame': '6, 9 and 12 month', 'description': 'WHO Quality of Life-Bref (WHOQUOL-Bref)'}, {'measure': 'Improvement in Quality of life assessed by LQLP', 'timeFrame': '6, 9 and 12 month', 'description': 'Lancashire Quality of Life Profile (LQLP)'}, {'measure': 'Changes from baseline in Neurocognition assessed by B-CATS', 'timeFrame': '6, 9 and 12 month', 'description': 'Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)'}, {'measure': 'Changes from baseline in Neurocognition assessed by BACS', 'timeFrame': '6, 9 and 12 month', 'description': 'Brief Assessment of Cognition in Schizophrenia (BACS)'}, {'measure': 'Changes from baseline in Neurocognition assessed by UPSA-B', 'timeFrame': '6, 9 and 12 month', 'description': 'University of California San Diego Performance based Skills Assessment (UPSA-B)'}, {'measure': 'Changes from baseline in Neurocognition assessed by MASC', 'timeFrame': '6, 9 and 12 month', 'description': 'Movie for the Assessment of Social Cognition (MASC)'}, {'measure': 'Changes from baseline in Neurocognition assessed by PFA', 'timeFrame': '6, 9 and 12 month', 'description': 'Pictures of Facial Affect (PFA)'}, {'measure': 'Treatment adherence', 'timeFrame': '6, 9 and 12 month'}, {'measure': 'Changes in Cumulative dose of concomitant or rescue medication', 'timeFrame': '6, 9 and 12 month'}, {'measure': 'Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling', 'timeFrame': '6, 9 and 12 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': "Current antipsychotic treatments of schizophrenia are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent given by the subject\n* DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90)\n* First documented diagnosis of schizophrenia must not be no older than seven years.\n* Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.\n* Initial PANSS total score of ≤ 75 at baseline.\n* proper contraception in female patients of childbearing potential\n* body mass index between 18 and 40.\n\nExclusion Criteria:\n\n* Lack of accountability\n* positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)\n* serious suicidal risk at screening visit\n* other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.\n* other relevant neurological or other medical disorders\n* pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT02926859', 'briefTitle': 'Enhancing Recovery in Early Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Central Institute of Mental Health, Mannheim'}, 'officialTitle': 'Enhancing Recovery in Early Schizophrenia - a Multi-center, Two-arm, Double-blind, Randomized Phase II Trial Investigating Cannabidiol Vs. Placebo As an Add-on to an Individualized Antipsychotic Treatment', 'orgStudyIdInfo': {'id': 'CBD-ESPRIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cannabidiol', 'description': 'Cannabidiol as add-on to individualized pharmacological treatment', 'interventionNames': ['Drug: Cannabidiol as add-on']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo as add-on to individualized pharmacological treatment', 'interventionNames': ['Drug: Placebo as add-on']}], 'interventions': [{'name': 'Cannabidiol as add-on', 'type': 'DRUG', 'description': 'Cannabidiol capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks', 'armGroupLabels': ['Cannabidiol']}, {'name': 'Placebo as add-on', 'type': 'DRUG', 'description': 'Placebo capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68159', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'F. Markus Leweke, MD', 'role': 'CONTACT', 'email': 'leweke@cimh.de', 'phone': '+49 621 1703', 'phoneExt': '2761'}, {'name': 'F. Markus Leweke, MD', 'role': 'CONTACT'}], 'facility': 'Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '80336', 'city': 'Munich', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Falkai, MD', 'role': 'CONTACT', 'email': 'Peter.Falkai@med.uni-muenchen.de'}, {'name': 'Peter Falkai, MD', 'role': 'CONTACT'}], 'facility': 'Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '10117', 'city': 'Berlin', 'state': 'B', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Henrik Walter, MD, PhD', 'role': 'CONTACT', 'email': 'henrik.walter@charite.de'}, {'name': 'Henrik Walter, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tanja Veselinovic, MD', 'role': 'CONTACT', 'email': 'tveselinovic@ukaachen.de'}, {'name': 'Tanja Veselinovic, MD', 'role': 'CONTACT'}], 'facility': 'Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '50924', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joseph Kambeitz, MD', 'role': 'CONTACT', 'email': 'Joseph.Kambeitz@uk-koeln.de'}, {'name': 'Joseph Kambeitz, MD', 'role': 'CONTACT'}], 'facility': 'Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniel Schöttle, MD', 'role': 'CONTACT'}], 'facility': 'Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'F. Markus Leweke, MD', 'role': 'CONTACT', 'email': 'leweke@cimh.de', 'phone': '+49 621 1703 2321'}, {'name': 'Cathrin Rohleder, PhD', 'role': 'CONTACT', 'email': 'rohleder@cimh.de', 'phone': '+49 621 1703 2333'}], 'overallOfficials': [{'name': 'F. Markus Leweke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Institute of Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Institute of Mental Health, Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}