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

Primary Purpose

Obsessive-compulsive Disorder

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
D-Cycloserine
Placebo
Sponsored by
Christian Rück
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-compulsive Disorder focused on measuring Obsessive-compulsive disorder, internet, cognitive-behaviour therapy, D-Cycloserine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D-Cycloserine

Placebo

Arm Description

D-Cycloserine, 5 pills (50mg), once per week in 5 weeks.

Placebo: 5 pills for 5 weeks, once per week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Euroqol
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)
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)
Change from Baseline global functioning after 12 weeks and 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.
Adverse events
Weekly adverse events reporting during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.

Full Information

First Posted
July 23, 2012
Last Updated
December 9, 2016
Sponsor
Christian Rück
Collaborators
The Swedish Research Council, Königska, Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01649895
Brief Title
D-Cycloserine as an Adjunct to Internet-CBT for OCD
Official Title
Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian Rück
Collaborators
The Swedish Research Council, Königska, Region Stockholm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
Keywords
Obsessive-compulsive disorder, internet, cognitive-behaviour therapy, D-Cycloserine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D-Cycloserine
Arm Type
Experimental
Arm Description
D-Cycloserine, 5 pills (50mg), once per week in 5 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: 5 pills for 5 weeks, once per week.
Intervention Type
Drug
Intervention Name(s)
D-Cycloserine
Other Intervention Name(s)
DCS, C3H6N2O2, Cycloserine
Intervention Description
Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Placebo pills as adjunct to internet-based cognitive-behaviour therapy
Primary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale (Y-BOCS) (clinician rated)
Description
Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
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
Secondary Outcome Measure Information:
Title
Obsessive Compulsive Scale - Revised (OCI-R)
Description
Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
Time Frame
W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Title
Yale Brown Obsessive Compulsive Scale (Y-BOCS)(self-rated)
Description
Weekly change from Baseline in OCD severity during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.
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
Title
Montgomery Asberg Depression Rating Scale Self-rating (MADRS-S)
Description
Change from Baseline in depression after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
Time Frame
W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Title
Euroqol
Description
Change from Baseline in quality of life after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
Time Frame
W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Title
Trimbos and institute of medical technology assessment cost questionnaire for psychiatry (TIC-P)
Description
Change from Baseline in societal costs after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
Time Frame
W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Title
Global assessment of functioning (GAF)
Description
Change from Baseline global functioning after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
Time Frame
W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Title
Clinical global impression (CGI)
Description
Change from Baseline in Clinical global impression after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
Time Frame
W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Title
Adverse events
Description
Weekly adverse events reporting during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Rück, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25970252
Citation
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.
Results Reference
result

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

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