D-Cycloserine as an Adjunct to Internet-CBT for OCD - Full Text View

Purpose

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.

Condition	Intervention	Phase
Obsessive-compulsive Disorder	Drug: D-Cycloserine Drug: Placebo	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Cycloserine

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.

Secondary Outcome Measures:

Obsessive Compulsive Scale - Revised (OCI-R) [ Time Frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended ] [ Designated as safety issue: No ]
Change from Baseline in OCD severity after 12 weeks and 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 ] [ Designated as safety issue: No ]
Weekly change from Baseline in OCD severity during 12 weeks of treatment and 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 ] [ Designated as safety issue: No ]
Change from Baseline in depression after 12 weeks and 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 ] [ Designated as safety issue: No ]
Change from Baseline in quality of life after 12 weeks and 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 ] [ Designated as safety issue: No ]
Change from Baseline in societal costs after 12 weeks and 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 ] [ Designated as safety issue: No ]
Change from Baseline global functioning after 12 weeks and 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 ] [ Designated as safety issue: No ]
Change from Baseline in Clinical global impression after 12 weeks and 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 ] [ Designated as safety issue: Yes ]
Weekly adverse events reporting during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.

Estimated Enrollment:	128
Study Start Date:	August 2012
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: DCS C3H6N2O2 Cycloserine
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 Name: Sugar pill

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649895

Contacts

Contact: Christian Rück, MD, PhD	+46(0)704843392	christian.ruck@ki.se
Contact: Erik Andersson, MSc	+46(0)736716335	erik.m.andersson@ki.se

Locations

Sweden
M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom	Recruiting
Stockholm, Sweden, 141 86
Contact: Christian Ruck, MD, PHD +46(0)70484 33 92 Christian.ruck@ki.se
Contact: Nils Lindefors, MD,prof. +46(0)708326208 nils.lindefors@ki.se
Principal Investigator: Christian Ruck, MD, PhD

Sponsors and Collaborators

Christian Rück

The Swedish Research Council

Königska

Stockholm County Council, Sweden

Investigators

Principal Investigator:

Christian Rück, MD, PhD

Karolinska Institutet

More Information

Additional Information:

overall information in swedish This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Christian Rück, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT01649895 History of Changes
Other Study ID Numbers:	2011‐002819‐28
Study First Received:	July 23, 2012
Last Updated:	September 29, 2012
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:

Obsessive-compulsive disorder
internet
cognitive-behaviour therapy
D-Cycloserine

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013