Overview

This trial is active, not recruiting.

Condition obsessive-compulsive disorder
Treatments d-cycloserine, placebo
Phase phase 4
Sponsor Christian Rück
Collaborator The Swedish Research Council
Start date August 2012
End date March 2014
Trial size 128 participants
Trial identifier NCT01649895, 2011‐002819‐28

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
D-Cycloserine, 5 pills (50mg), once per week in 5 weeks.
d-cycloserine DCS
Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
(Placebo Comparator)
Placebo: 5 pills for 5 weeks, once per week.
placebo Sugar pill
Placebo pills as adjunct to internet-based cognitive-behaviour therapy

Primary Outcomes

Measure
Yale Brown Obsessive Compulsive Scale (Y‐BOCS) (clinician rated)
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

Secondary Outcomes

Measure
Obsessive Compulsive Scale - Revised (OCI-R)
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)
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)
time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Euroqol
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)
time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Global assessment of functioning (GAF)
time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Clinical global impression (CGI)
time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Adverse events
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial
Principal investigator Christian Rück, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Karolinska Institutet.