Obsessive-compulsive Disorder
Conditions
Keywords
Obsessive-compulsive disorder, internet, cognitive-behaviour therapy, D-Cycloserine
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
Interventions
DRUGD-Cycloserine
Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
DRUGPlacebo
Placebo pills as adjunct to internet-based cognitive-behaviour therapy
Sponsors
The Swedish Research Council
Königska
Region Stockholm
Christian Rück
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (Y-BOCS) (clinician rated) | 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
| Measure | Time frame | Description |
|---|---|---|
| Obsessive Compulsive Scale - Revised (OCI-R) | 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. |
| 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 | 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) | 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. |
| Euroqol | 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. |
| 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 | 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) | 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. |
| Clinical global impression (CGI) | 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. |
| Adverse events | 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. |
Countries
Sweden
Outcome results
None listed