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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
Placebo pills as adjunct to internet-based cognitive-behaviour therapy
M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom
Stockholm, Sweden
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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