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

NCT01649895 | Completed Phase 4 DMC

• 1 other identifier: 2011-002819-28
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-compulsive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Obsessive Compulsive Scale - Revised (OCI-R)

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

• Yale Brown Obsessive Compulsive Scale (Y-BOCS)(self-rated)

  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

• Montgomery Asberg Depression Rating Scale Self-rating (MADRS-S)

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

• Euroqol

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

• Trimbos and institute of medical technology assessment cost questionnaire for psychiatry (TIC-P)

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

Study Arms (2)

D-Cycloserine

EXPERIMENTAL

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

Drug: D-Cycloserine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

D-Cycloserine DRUG

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

Also known as: DCS, C3H6N2O2, Cycloserine

D-Cycloserine

Placebo DRUG

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

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Rück: lead
• The Swedish Research Council: collaborator
• Königska: collaborator
• Region Stockholm: collaborator

Study Sites (1)

M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25970252 RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cycloserine; Sugars

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Study Officials

• Christian Rück, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 12, 2016

Record last verified: 2016-12

Locations

SE (1)