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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
| Königska | UNKNOWN |
| Region Stockholm | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-Cycloserine | Experimental | D-Cycloserine, 5 pills (50mg), once per week in 5 weeks. |
|
| Placebo | Placebo Comparator | Placebo: 5 pills for 5 weeks, once per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Cycloserine | Drug | Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Rück, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom | Stockholm | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25970252 | Result | 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. |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo pills as adjunct to internet-based cognitive-behaviour therapy |
|
|
Weekly change from Baseline in OCD severity during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended. |
| 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) | Change from Baseline in depression after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | W0, W13, Long term follow-up 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. | 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) | Change from Baseline in societal costs after 12 weeks and at 3-, 12- and 24 months after treatment has ended. | W0, W13, Long term follow-up 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. | W0, W13, Long term follow-up 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. | W0, W13, Long term follow-up 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. | 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 |
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |