Obsessive-compulsive Disorder Clinical Trial
Official title:
Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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