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Completed

NCT Number: NCT01649895

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

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom

Stockholm, 141 86, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-cycloserine

Drug

Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy

Other names: DCS, C3H6N2O2, Cycloserine

Placebo

Drug

Placebo pills as adjunct to internet-based cognitive-behaviour therapy

Other names: Sugar pill

Primary outcomes

  1. 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

    Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.

Secondary outcomes

  1. Obsessive Compulsive Scale - Revised (OCI-R)

    Time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended

    Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.

  2. 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

    Weekly change from Baseline in OCD severity during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.

  3. 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

    Change from Baseline in depression after 12 weeks and at 3-, 12- and 24 months after treatment has ended.

  4. Euroqol

    Time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended

    Change from Baseline in quality of life after 12 weeks and at 3-, 12- and 24 months after treatment has ended.

  5. 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

    Change from Baseline in societal costs after 12 weeks and at 3-, 12- and 24 months after treatment has ended.

  6. Global assessment of functioning (GAF)

    Time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended

    Change from Baseline global functioning after 12 weeks and at 3-, 12- and 24 months after treatment has ended.

  7. Clinical global impression (CGI)

    Time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended

    Change from Baseline in Clinical global impression after 12 weeks and at 3-, 12- and 24 months after treatment has ended.

  8. 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

    Weekly adverse events reporting during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.

Sponsors and collaborators

Lead sponsor

Christian Rück

Other

Collaborators

  • Königska
  • Region Stockholm
  • The Swedish Research Council

Registry information

Official study title

Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2012
Registry last updated
Dec 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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