D-Cycloserine as an Adjunct to Internet-CBT for OCD

Study Overview
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Brief Summary
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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
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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

Official Title
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Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial

Conditions
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Obsessive-compulsive Disorder

Intervention / Treatment
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* Drug: D-Cycloserine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-Cycloserine<br>D-Cycloserine, 5 pills (50mg), once per week in 5 weeks. | Drug: D-Cycloserine<br>* Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy<br>* Other names: Cycloserine;|
| Placebo Comparator: Placebo<br>Placebo: 5 pills for 5 weeks, once per week. | Drug: Placebo<br>* Placebo pills as adjunct to internet-based cognitive-behaviour therapy<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale (Y-BOCS) (clinician rated) | Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obsessive Compulsive Scale - Revised (OCI-R) | Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended | 
| Yale Brown Obsessive Compulsive Scale (Y-BOCS)(self-rated) | Weekly change from Baseline in OCD severity during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended. | 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 | 
| Montgomery Asberg Depression Rating Scale Self-rating (MADRS-S) | Change from Baseline in depression after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended | 
| Euroqol | Change from Baseline in quality of life after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended | 
| Trimbos and institute of medical technology assessment cost questionnaire for psychiatry (TIC-P) | Change from Baseline in societal costs after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended | 
| Global assessment of functioning (GAF) | Change from Baseline global functioning after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended | 
| Clinical global impression (CGI) | Change from Baseline in Clinical global impression after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended | 
| Adverse events | Weekly adverse events reporting during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-compulsive disorder, internet, cognitive-behaviour therapy, D-Cycloserine