Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT01649895
Status:
COMPLETED
Last Update Posted:
2016-12-12
First Post:
2012-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D-Cycloserine as an Adjunct to Internet-CBT for OCD
Sponsor:
Christian Rück
Organization:
Study Overview
Official Title:
Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: