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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649895
• Other study ID #: 2011-002819-28
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2012
• Last updated: December 9, 2016
• Start date: August 2012
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Drug:
• D-Cycloserine
Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
• Placebo
Placebo pills as adjunct to internet-based cognitive-behaviour therapy

Locations

Country	Name	City	State
Sweden	M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Christian Rück	Königska, Stockholm County Council, Sweden, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Andersson E, Hedman E, Enander J, Radu Djurfeldt D, Ljótsson B, Cervenka S, Isung J, Svanborg C, Mataix-Cols D, Kaldo V, Andersson G, Lindefors N, Rück C. D-Cycloserine vs Placebo as Adjunct to Cognitive Behavioral Therapy for Obsessive-Compulsive Disorde — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes