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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-compulsive Disorder
• Intervention / Treatment: Drug: D-Cycloserine; Drug: Placebo

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: D-Cycloserine; D-Cycloserine, 5 pills (50mg), once per week in 5 weeks.	Drug: D-Cycloserine; Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy; Other Names: Cycloserine; DCS; C3H6N2O2
PLACEBO_COMPARATOR: Placebo; Placebo: 5 pills for 5 weeks, once per week.	Drug: Placebo; Placebo pills as adjunct to internet-based cognitive-behaviour therapy; Other Names: Sugar pill

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Christian Rück
• Collaborators: The Swedish Research Council; Region Stockholm; Königska

Publications and helpful links

General Publications

• Andersson E, Hedman E, Enander J, Radu Djurfeldt D, Ljotsson B, Cervenka S, Isung J, Svanborg C, Mataix-Cols D, Kaldo V, Andersson G, Lindefors N, Ruck C. D-Cycloserine vs Placebo as Adjunct to Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder and Interaction With Antidepressants: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Jul;72(7):659-67. doi: 10.1001/jamapsychiatry.2015.0546.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (ESTIMATE): July 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2016
• Last Update Submitted That Met QC Criteria: December 9, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: internet; D-Cycloserine; Obsessive-compulsive disorder; cognitive-behaviour therapy
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Anti-Bacterial Agents; Antitubercular Agents; Antibiotics, Antitubercular; Anti-Infective Agents, Urinary; Renal Agents; Cycloserine
• Other Study ID Numbers: 2011-002819-28