Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-02-22 @ 7:26 PM
Study NCT ID:
NCT01750359
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Curcumin in Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale', 'timeFrame': 'Change in the scores from baseline at six weeks'}, {'measure': 'Montgomery-Asberg Depression Rating Scale', 'timeFrame': 'Change in the scores from baseline at six weeks'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression', 'timeFrame': 'Change in the scores from baseline at six weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['antioxidants', 'curcumin', 'depression'], 'conditions': ['Major Depression']}, 'descriptionModule': {'briefSummary': 'Antidepressants generally do not lead to an immediate relief of symptoms. Most people will not see a significant improvement for at least 4 weeks. Studies have generally shown that the full benefits of antidepressant therapy may take as long as 8 to 12 weeks. However, this timeline is variable among individuals.Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects. Curcumin has been found to possess antidepressant action in various animal models of depression. Chronic administration of curcumin has been reported to exert antidepressant-like action in olfactory bulbectomy model of depression in rats. Although the mechanism of the antidepressant effect of curcumin is not fully understood, it is hypothesized that it acts through inhibiting the monoamine oxidase enzyme and modulating the release of serotonin and dopamine.In randomized, double-blind, placebo-controlled study 40 patients will be randomized to receive either 500 mg/day of curcumin or placebo together with antidepressants for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nMales and females in age 20-60 years\n\nMajor depressive episode according to DSM-IV\n\nClinical Global Impression Severity Scale scores more than 4\n\nHamilton Depression Rating Scale scores more than 21\n\nMontgomery and Asberg Depression Rating Scale scores more than 22\n\nAbility and willingness to sign informed consent\n\nExclusion Criteria:\n\nEvidence of organic brain damage\n\nMental retardation\n\nAlcohol or drug abuse\n\nAn unstable medical condition\n\nAny significant medical or neurological illness\n\nPatients with a known hypersensitivity to curcumin or other components of the product\n\nPregnant women or women who intend to become pregnant\n\nReceiving any antidepressant and mood-stabilizers'}, 'identificationModule': {'nctId': 'NCT01750359', 'briefTitle': 'Efficacy and Safety Curcumin in Depression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Beersheva Mental Health Center'}, 'officialTitle': 'The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'LBM-2010'}, 'secondaryIdInfos': [{'id': 'IsraelMHC', 'type': 'OTHER', 'domain': "Tirat Carmel &Be'er Sheva MHC"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'curcumin', 'interventionNames': ['Drug: curcumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: curcumin']}], 'interventions': [{'name': 'curcumin', 'type': 'DRUG', 'description': '500 mg/day for 6 week', 'armGroupLabels': ['curcumin', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84170', 'city': 'Tirat Carmel', 'country': 'Israel', 'facility': 'Tirat Carmel Mental Health Center', 'geoPoint': {'lat': 32.76021, 'lon': 34.97183}}], 'overallOfficials': [{'name': 'Joseph Bergman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tirat Carmel'}, {'name': 'Vladimir Lerner, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beersheva Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vladimir Lerner', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tirat Carmel Mental Health Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'A/Professor, Head of department', 'investigatorFullName': 'Vladimir Lerner', 'investigatorAffiliation': 'Beersheva Mental Health Center'}}}}