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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Swedish Research Council
Königska
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Christian Rück, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01649895
First received: July 23, 2012
Last updated: September 27, 2013
Last verified: September 2013
  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:


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: March 2014
Estimated Primary Completion Date: March 2014 (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

Locations
Sweden
M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom
Stockholm, Sweden, 141 86
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:
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 27, 2013
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
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality 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 April 15, 2014