Obsessive-compulsive DisorderPhase 4NCT01649895
D-Cycloserine as an Adjunct to Internet-CBT for OCD
A Phase 4 study testing D-Cycloserine in people with Obsessive-compulsive Disorder, run by Christian Rück at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- D-Cycloserine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2012to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom
Stockholm, 141 86
About this study
Official title: Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial
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.
Read the 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
- Conditions
- Obsessive-compulsive Disorder
- Being tested
- D-Cycloserine, Placebo
- Keywords
- Obsessive-compulsive disorder, internet, cognitive-behaviour therapy, D-Cycloserine
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-CycloserineDrug
Also called DCS, C3H6N2O2, Cycloserine
Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
PlaceboDrug
Also called Sugar pill
Placebo pills as adjunct to internet-based cognitive-behaviour therapy
| Study group | Role | What they receive |
|---|---|---|
| D-Cycloserine | Experimental | D-Cycloserine, 5 pills (50mg), once per week in 5 weeks. Receives: Drug: D-Cycloserine |
| Placebo | Placebo comparator | Placebo: 5 pills for 5 weeks, once per week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
Measured: 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)
Weekly change from Baseline in OCD severity during 12 weeks of treatment and at 3-, 12- and 24 months after treatment has ended.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Rück
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Königska, Region Stockholm
- Responsible party
- Sponsor-investigator, Christian Rück, Karolinska Institutet
- Investigators
- Christian Rück, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649895
- Sponsor's protocol ID
- 2011-002819-28
- Status last verified
- Dec 2016
- First submitted
- 23 Jul 2012
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25970252
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01649895
- Acronym / sponsor ID
- 2011-002819-28
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- Obsessive-compulsive disorder, internet, cognitive-behaviour therapy, D-Cycloserine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Christian RückUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Königska, Region Stockholm
- Study start
- Aug 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Cycloserine | Experimental | Drug: D-CycloserineD-Cycloserine, 5 pills (50mg), once per week in 5 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: 5 pills for 5 weeks, once per week. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-CycloserineAlso: DCS, C3H6N2O2, CycloserinePredicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy | Drug | D-Cycloserine |
| PlaceboAlso: Sugar pillPlacebo pills as adjunct to internet-based cognitive-behaviour therapy | Drug | Placebo |
Primary outcome
Yale Brown Obsessive Compulsive Scale (Y-BOCS) (clinician rated)
Time frame: 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.
8 secondary outcomes
Obsessive Compulsive Scale - Revised (OCI-R)
Time frame: 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)
Time frame: 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)
Time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Euroqol
Time frame: 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)
Time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Global assessment of functioning (GAF)
Time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Clinical global impression (CGI)
Time frame: W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended
Adverse events
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Results publication: PubMed 25970252Andersson 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Rück, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing D-Cycloserine in people with Obsessive-compulsive Disorder, run by Christian Rück at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale (Y-BOCS) (clinician rated) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01649895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.