Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-01 @ 2:45 AM
Study NCT ID:
NCT02088060
Status:
TERMINATED
Last Update Posted:
2024-12-27
First Post:
2014-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients
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'}, {'id': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 150}}, 'statusModule': {'whyStopped': 'Following the expiry of the original research grant, no follow-up financing could be provided to complete the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2014-03-13', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Positive and Negative Syndrome Scale (PANSS) total score', 'timeFrame': 'within 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in the PANSS subscores and clusters', 'timeFrame': 'within 4 weeks'}, {'measure': 'Changes in the Clinical Global Impression score', 'timeFrame': 'within 4 weeks'}, {'measure': 'Changes in the Global Assessment of Functioning Scale', 'timeFrame': 'within 4 weeks'}, {'measure': 'Changes in the Personal and Social Performance Scale', 'timeFrame': 'within 4 weeks'}, {'measure': 'Changes in the Calgary Depression Scale for Schizophrenia', 'timeFrame': 'within 4 weeks'}, {'measure': 'Changes in the Hamilton Anxiety Scale', 'timeFrame': 'within 4 weeks'}, {'measure': 'Changes in cognitive skills', 'timeFrame': 'within 4 weeks'}, {'measure': 'Response to antipsychotic medication', 'timeFrame': 'within 4 weeks'}, {'measure': 'Plasma levels of endogenous cannabinoids', 'timeFrame': 'within 4 weeks'}, {'measure': 'Changes in physiological parameter', 'timeFrame': 'within 4 weeks'}, {'measure': 'Changes in the UKU Side Effect Rating Scale', 'timeFrame': 'within 4 weeks'}, {'measure': 'Columbia Suicidality Severity Rating Scale', 'timeFrame': 'within 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': "Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's population. Current antipsychotics 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. While cannabidiol has no psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute paranoid schizophrenics the investigators showed a significant clinical improvement in all symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol displayed a significantly superior side-effect profile. This study is to evaluate the efficacy and safety of this novel treatment option in comparison to placebo and olanzapine, an established second generation antipsychotic in the treatment of acute schizophrenia and schizophrenia maintenance therapy, in a four-week clinical trial."}, '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, 295.20, 295.30, 295.90 (American Psychiatric Association)\n* Patients must be within the first three years of illness, i.e. first diagnosis of schizophrenia is no older than three years.\n* Age 18 to 65 years, male or female\n* Minimal initial PANSS score of 75 at baseline\n* Female patients of childbearing potential need to utilize a proper method of contraception.\n* Body Mass Index between 18 and 40\n\nExclusion Criteria:\n\n* Lack of accountability (assessed by an independent psychiatrist)\n* History of treatment-resistant schizophrenia, defined as no response to at least two antipsychotics given for a minimum of 6 weeks each in an adequate dosage\n* Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)\n* Serious suicidal risk at screening visit (Subject to investigator's and independent psychiatrist's judgement: Poses a serious suicidal or homicidal risk at screening visit or has made a serious suicide attempt within the last 12 months prior to screening visit, or has exhibited homicidal behaviour at anytime during her/his lifetime)\n* Known intolerance or allergy to olanzapine or cannabidiol\n* Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia\n* Pregnancy, as determined through a β-HCG pregnancy test, or lactation"}, 'identificationModule': {'nctId': 'NCT02088060', 'briefTitle': 'A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central Institute of Mental Health, Mannheim'}, 'officialTitle': 'A Four-week, Multicentre, Double-blinded, Randomised, Active- and Placebo- Controlled, Parallel-group Trial Investigating Efficacy and Safety of Cannabidiol in Acute, Early-stage Schizophrenic Patients', 'orgStudyIdInfo': {'id': 'CBD-FEP'}, 'secondaryIdInfos': [{'id': '2012-004335-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cannabidiol', 'description': 'Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks', 'interventionNames': ['Drug: Cannabidiol', 'Drug: Placebo Olanzapine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olanzapine', 'description': 'Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks', 'interventionNames': ['Drug: Olanzapine', 'Drug: Placebo Cannabidiol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks', 'interventionNames': ['Drug: Placebo Cannabidiol', 'Drug: Placebo Olanzapine']}], 'interventions': [{'name': 'Cannabidiol', 'type': 'DRUG', 'description': 'Cannabidiol capsules', 'armGroupLabels': ['Cannabidiol']}, {'name': 'Olanzapine', 'type': 'DRUG', 'otherNames': ['Olanzapine 1A pharma'], 'description': 'Olanzapine capsules', 'armGroupLabels': ['Olanzapine']}, {'name': 'Placebo Cannabidiol', 'type': 'DRUG', 'description': 'Placebo cannabidiol capsules', 'armGroupLabels': ['Olanzapine', 'Placebo']}, {'name': 'Placebo Olanzapine', 'type': 'DRUG', 'description': 'Placebo olanzapine capsules', 'armGroupLabels': ['Cannabidiol', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Psychiatric Centre Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'zip': '68115', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Department of General Psychiatry, Heidelberg University', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '68159', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '80336', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Dept. of Psychiatry and Psychotherapy, Technical University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '06112', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'overallOfficials': [{'name': 'F. Markus Leweke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Institute of Mental Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Institute of Mental Health, Mannheim', 'class': 'OTHER'}, 'collaborators': [{'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, {'name': 'Heidelberg University', 'class': 'OTHER'}, {'name': 'Technical University of Munich', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}