Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
128 participants
INTERVENTIONAL
2012-08-31
2016-06-30
Brief Summary
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Detailed Description
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Primary 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.
Trial Design: Double blinded randomized controlled trial
Dose/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.
Primary Endpoint: Change from W0-W13 and 3-months follow-up.
Efficacy Parameters: Y-BOCS clinician rated.
Safety 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.
Description of Trial Subjects: Fulfilling diagnostic criteria of OCD not associated with hoarding.
Number of Subjects: 128
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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D-Cycloserine
D-Cycloserine, 5 pills (50mg), once per week in 5 weeks.
D-Cycloserine
Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
Placebo
Placebo: 5 pills for 5 weeks, once per week.
Placebo
Placebo pills as adjunct to internet-based cognitive-behaviour therapy
Interventions
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D-Cycloserine
Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
Placebo
Placebo pills as adjunct to internet-based cognitive-behaviour therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female
* ≥ 18 years
* Currently living in Stockholm, Uppland, Örebro, Södermanland, Gästrikland, Västmanland and Östergötland county in Sweden.
* Primary diagnosis of OCD according to the DSM-IV-TR.
* Signed informed consent
* Have regular access to a computer with internet access and skills to use the web
* Have received information about the need of using contraception
Exclusion Criteria
* Patients unlikely to cooperate fully in the study
* Patients not able to read or understand the basics of the ICBT self-help material
* Psychotropic medication changes within two months prior to treatment
* Completed CBT for OCD within last 12 months
* Y-BOCS \[21\] \< 16 at Psychiatrist visit (6.2.3)pi
* OCD symptoms primarily associated with hoarding.
* Other primary axis I diagnosis according to the Mini-International Neuropsychiatric Interview (MINI) \[34\]
* Ongoing substance dependence
* Lifetime bipolar disorder or psychosis
* Suicidal ideation
* Axis II diagnosis that could jeopardize treatment participation
* Serious physical illness that will be an obstacle in ICBT and DCS
* Other ongoing psychological treatments that could affect OCD symptoms
* Epilepsia
* Renal impairment
* Hypersensitivity to D-Cycloserine
* Porphyria
* Chronic Alcoholism
18 Years
100 Years
ALL
No
Sponsors
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The Swedish Research Council
OTHER_GOV
Königska
UNKNOWN
Region Stockholm
OTHER_GOV
Christian Rück
OTHER
Responsible Party
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Christian Rück
MD, PhD
Principal Investigators
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Christian Rück, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom
Stockholm, , Sweden
Countries
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References
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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.
Other Identifiers
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2011-002819-28
Identifier Type: -
Identifier Source: org_study_id