Internet-based cognitive behavior therapy in combination with D-Cycloserine for Obsessive Compulsive Disorder: A double blinded randomized controlled trial

Phase 1

• Conditions: Obsessive Compulsive disorder; MedDRA version: 14.1Level: PTClassification code 10029898Term: Obsessive-compulsive disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-002819-28-SE
• Lead Sponsor: Stockholms Läns Landsting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-03
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 128

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary aim with the study is to investigate whether D-Cycloserine (DCS) gives incremental effects to Internet-based cognitive behavior therapy (ICBT) in terms of reduced Obsessive Compulsive Disorder (OCD) symptoms at post-treatment and follow-up.;Secondary Objective: Secondary aims are to a) replicate previous findings in that DCS fastens the effects of ICBT, 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. ;Primary end point(s): The clinician rated Yale Brown Obsessive-Compulsive Scale total score expressed as the change from baseline to last post-baseline value. ;Timepoint(s) of evaluation of this end point: Baseline (W0)<br>Post-treatment (W13)<br>Short-term follow-up (3 months after completion of treatment) Long-term follow-up (12 months after completion of treatment) <br>Long-term follow-up (24 months after completion of treatment)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Yale Brown Obsessive-Compulsive Scale (Y-BOCS) self-rating. <br>•Obsessive Compulsive Inventory – Revised (OCI-R).<br>•Montgomery Åsberg Depression Rating Scale – Self report (MADRS-S). <br>•Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P). <br>•Euroqol (EQ-5D).<br>•Global Assessment of Functioning (GAF). <br>•Clinical Global Impression (CGI). <br>•Remission status according to the Structured Clinical Interview for DSM-IV (SCID-I) criteria for OCD. <br>;Timepoint(s) of evaluation of this end point: Baseline (W0)<br>Post-treatment (W13)<br>Short-term follow-up (3 months after completion of treatment) Long-term follow-up (12 months after completion of treatment) <br>Long-term follow-up (24 months after completion of treatment)