Clinical trial NCT01649895: D-Cycloserine as an Adjunct to Internet-CBT for OCD
Official title: Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive-compulsive Disorder
Keywords: Obsessive-compulsive disorder
internet
cognitive-behaviour therapy
D-Cycloserine
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Königska
name: Region Stockholm
First posted: 2012-07-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Trial Objectives:

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

Eligibility criteria: Inclusion Criteria:

* Outpatients
* 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:

* Pregnancy or breast feeding
* 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

Primary outcomes:
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
Secondary outcomes:
measure: Obsessive Compulsive Scale - Revised (OCI-R)
timeFrame: W0, W13, Long term follow-up 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
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
measure: Euroqol
timeFrame: W0, W13, Long term follow-up 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
measure: Global assessment of functioning (GAF)
timeFrame: W0, W13, Long term follow-up 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
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
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom
Study officials:
affiliation: Karolinska Institutet
name: Christian Rück, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.