Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-29 @ 8:40 PM
Study NCT ID:
NCT01649895
Status:
COMPLETED
Last Update Posted:
2016-12-12
First Post:
2012-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D-Cycloserine as an Adjunct to Internet-CBT for OCD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-09', 'studyFirstSubmitDate': '2012-07-23', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yale Brown Obsessive Compulsive Scale (Y-BOCS) (clinician rated)', 'timeFrame': 'W0,W6,W13. Mid assessments immediately before and after DCS treatment. Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.'}], 'secondaryOutcomes': [{'measure': 'Obsessive Compulsive Scale - Revised (OCI-R)', 'timeFrame': 'W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.'}, {'measure': 'Yale Brown Obsessive Compulsive Scale (Y-BOCS)(self-rated)', 'timeFrame': 'W0, W1,W2,W3,W4,W5,W6,W7,W8,W9,W10,W11,W12, Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Weekly change from Baseline in OCD severity during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.'}, {'measure': 'Montgomery Asberg Depression Rating Scale Self-rating (MADRS-S)', 'timeFrame': 'W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Change from Baseline in depression after 12 weeks and at 3-, 12- and 24 months after treatment has ended.'}, {'measure': 'Euroqol', 'timeFrame': 'W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Change from Baseline in quality of life after 12 weeks and at 3-, 12- and 24 months after treatment has ended.'}, {'measure': 'Trimbos and institute of medical technology assessment cost questionnaire for psychiatry (TIC-P)', 'timeFrame': 'W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Change from Baseline in societal costs after 12 weeks and at 3-, 12- and 24 months after treatment has ended.'}, {'measure': 'Global assessment of functioning (GAF)', 'timeFrame': 'W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Change from Baseline global functioning after 12 weeks and at 3-, 12- and 24 months after treatment has ended.'}, {'measure': 'Clinical global impression (CGI)', 'timeFrame': 'W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Change from Baseline in Clinical global impression after 12 weeks and at 3-, 12- and 24 months after treatment has ended.'}, {'measure': 'Adverse events', 'timeFrame': 'W0, W1,W2,W3,W4,W5,W6,W7,W8,W9,W10,W11,W12,W13 Long term follow-up at 3-, 12- and 24 months after treatment has ended', 'description': 'Weekly adverse events reporting during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obsessive-compulsive disorder', 'internet', 'cognitive-behaviour therapy', 'D-Cycloserine'], 'conditions': ['Obsessive-compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '25970252', 'type': 'RESULT', 'citation': 'Andersson E, Hedman E, Enander J, Radu Djurfeldt D, Ljotsson B, Cervenka S, Isung J, Svanborg C, Mataix-Cols D, Kaldo V, Andersson G, Lindefors N, Ruck C. D-Cycloserine vs Placebo as Adjunct to Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder and Interaction With Antidepressants: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Jul;72(7):659-67. doi: 10.1001/jamapsychiatry.2015.0546.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine if D-Cycloserine is an effective adjunct to internet-based cognitive behaviour therapy for patients with obsessive-compulsive disorder.', 'detailedDescription': 'Trial Objectives:\n\nPrimary aim is to investigate whether D-Cycloserine gives incremental effects to ICBT in terms of reduced OCD symptoms. Secondary aims are to a) replicate previous findings in that DCS fastens the effects of CBT, b) correlate the fastened effect to overall treatment adherence and c) investigate gene variation and therapeutic factors as predictors of symptom severity, symptom type and treatment response.\n\nTrial Design: Double blinded randomized controlled trial\n\nDose/Duration: 5 capsules of 50 mg D-Cycloserine or placebo. 1 pcs per week for 5 weeks. All participants also receive Internet-based cognitive behavior therapy for 12 weeks.\n\nPrimary Endpoint: Change from W0-W13 and 3-months follow-up.\n\nEfficacy Parameters: Y-BOCS clinician rated.\n\nSafety Parameters: Adverse Events assessed weekly via the internet and also at post-treatment and at 3-months follow-up using face-to-face clinician assessments.\n\nDescription of Trial Subjects: Fulfilling diagnostic criteria of OCD not associated with hoarding.\n\nNumber of Subjects: 128'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients\n* Male or female\n* ≥ 18 years\n* Currently living in Stockholm, Uppland, Örebro, Södermanland, Gästrikland, Västmanland and Östergötland county in Sweden.\n* Primary diagnosis of OCD according to the DSM-IV-TR.\n* Signed informed consent\n* Have regular access to a computer with internet access and skills to use the web\n* Have received information about the need of using contraception\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Patients unlikely to cooperate fully in the study\n* Patients not able to read or understand the basics of the ICBT self-help material\n* Psychotropic medication changes within two months prior to treatment\n* Completed CBT for OCD within last 12 months\n* Y-BOCS \\[21\\] \\< 16 at Psychiatrist visit (6.2.3)pi\n* OCD symptoms primarily associated with hoarding.\n* Other primary axis I diagnosis according to the Mini-International Neuropsychiatric Interview (MINI) \\[34\\]\n* Ongoing substance dependence\n* Lifetime bipolar disorder or psychosis\n* Suicidal ideation\n* Axis II diagnosis that could jeopardize treatment participation\n* Serious physical illness that will be an obstacle in ICBT and DCS\n* Other ongoing psychological treatments that could affect OCD symptoms\n* Epilepsia\n* Renal impairment\n* Hypersensitivity to D-Cycloserine\n* Porphyria\n* Chronic Alcoholism'}, 'identificationModule': {'nctId': 'NCT01649895', 'briefTitle': 'D-Cycloserine as an Adjunct to Internet-CBT for OCD', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2011-002819-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-Cycloserine', 'description': 'D-Cycloserine, 5 pills (50mg), once per week in 5 weeks.', 'interventionNames': ['Drug: D-Cycloserine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: 5 pills for 5 weeks, once per week.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'D-Cycloserine', 'type': 'DRUG', 'otherNames': ['DCS', 'C3H6N2O2', 'Cycloserine'], 'description': 'Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy', 'armGroupLabels': ['D-Cycloserine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'Placebo pills as adjunct to internet-based cognitive-behaviour therapy', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Christian Rück, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christian Rück', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}, {'name': 'Königska', 'class': 'UNKNOWN'}, {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Christian Rück', 'investigatorAffiliation': 'Karolinska Institutet'}}}}