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

Christian Rück

Status and phase: Completed; Phase 4

Conditions: Obsessive-compulsive Disorder

Treatments: Drug: D-Cycloserine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01649895

2011-002819-28

Details and patient eligibility

About

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.

Full 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

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

D-Cycloserine

Experimental group

Description:

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

Treatment:

Drug: D-Cycloserine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo