Obsessive-Compulsive DisorderPhase 4NCT02656342
Translational Approach to the Understanding and Treatment of Obsessive-Compulsive Disorder (OCD). Can D-Cycloserine Enhance and Stabilize the Treatment-response in Relapsed and Non-responding OCD-patients?
A Phase 4 study testing D-Cycloserine in people with Obsessive-Compulsive Disorder, run by Haukeland University Hospital at 14 sites in Norway.
Trial summary
In this randomized controlled trial (RCT) the investigators experimentally test if patients with Obsessive-Compulsive Disorder (OCD) who have received treatment with exposure and response prevention (ERP), but either relapsed or not responded, profit from the combination of concentrated exposure based treatment (cET)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- D-Cycloserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 14 sitesNorway
- Study dates
- Nov 2015to Feb 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients
- ≥ 18 years
- Fulfilling diagnostic criteria of OCD according to the DSM-5
- Previously have received ERP-treatment delivered by trained therapist and either have responded and relapsed, or not responded to the treatment.
- Response is defined by ≥35% reduction with a post-treatment Y-BOCS score of ≤15, followed by a relapse as defined by > 35% increase in Y-BOCS score from post-treatment, a Y-BOCS score of 16 or more, and a Clinical Global Impression-Improvement Scale (CGI-I) score of 6 ("much worse") or higher.
- Non-responders are defined as those with a reduction in Y-BOCS scores from pre- to post-of less than 35%, and with a Y-BOCS score of ≥16 after treatment. In order to be classified as non-responder as opposed to "drop-out" the patient has to previously have received a minimum of 6 sessions.
Show all 9Show fewer
- There must be a minimum of 4 weeks since treatment ended.
- Fluent in Norwegian
- Signed informed consent
Who cannot join
- OCD symptoms primarily associated with hoarding
- Ongoing substance abuse/dependence
- Bipolar disorder or psychosis
- Ongoing suicidal ideation
- Mental Retardation, based on previous medical history
- If using antidepressants:
Show all 15Show fewer
- Not on stable dosage 12 weeks before the intervention
- Unwilling to remain on stable dosage during the four intervention days
- Unwilling to refrain from anxiolytics (e.g. benzodiazepines) and alcohol during the two days of exposure.
- Living > 1 hour drive by car/ train from the treatment location.
- Pregnancy or breast feeding (the participants are informed that they will have to use contraception the two days when the DCS/placebo is administered. Females will be asked if they are pregnant, and in case of doubt a pregnancy test is provided)
- Renal impairment
- Hypersensitivity to D-Cycloserine
- Porphyria
- Epilepsy
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Norway14 sites
Haukeland University Hospital
Bergen, 5021
Innlandet Hospital
Brumunddal, 2380
Forde Hospital
Førde, 6812
Sørlandet Hospital
Kristiansand, 4604
Nord Trøndelag Hospital
Levanger, 7601
Akershus University Hospital
Lorenskog, 1478
More and Romsdal Hospital
Molde
Østfold Hospital
Moss, 1635
Oslo University Hospital
Oslo, 0424
Vestre Viken
Sandvika, 1300
Stavanger University Hospital
Stavanger
Sykehuset i Vestfold
Tønsberg, 3103
Tromso University Hospital
Tromsø
St. Olavs Hospital
Trondheim, 7006
About this study
Official title: Translational Approach to the Understanding and Treatment of Obsessive-Compulsive Disorder (OCD). Can D-Cycloserine Enhance and Stabilize the Treatment-response in Relapsed and Non-responding OCD-patients? A Randomized, Double-blind, Placebo-controlled National Study
In this randomized controlled trial (RCT) the investigators experimentally test if patients with Obsessive-Compulsive Disorder (OCD) who have received treatment with exposure and response prevention (ERP), but either relapsed or not responded, profit from the combination of concentrated exposure based treatment (cET) and the NMDA-agonist (N-methyl-d-aspartate) d-cycloserine (DCS), targeting fear relevant areas in amygdala and pre-frontal cortex.
The project expects to demonstrate a significant improvement in all groups, and anticipate that a higher proportion of the patients who receive DCS will show a better long-term gain from the treatment, as compared to the placebo group at follow-up (3 mon, 12 mon, and 5 years after treatment). In addition, the project will highlight changes in depression, sleep, global functioning, quality of life, work and social status. Changes in medication and use of health care will be included and related to the main objective of the study.
Read the detailed description
A total of 160 relapsed and non-responding OCD-patients, treated with exposure and response prevention (ERP) in the specialist Health care in Norway, are planned to participate in the study: "Translation approach to the understanding and treatment of Obsessive-Compulsive Disorder (OCD). Can D-cycloserine (DCS) enhance and stabilize the treatment-response in relapsed and non-responding OCD-patients? A randomized, double-blind, placebo-controlled national study." Estimated start of inclusion is November 2015 and the inclusion period lasts for maximum 2 years. All participants are referred to the specialist health care and are pre-screen by the local OCD-team. Before inclusion, the patients will fill in a number of questionnaires on-line and all patients who meet the inclusion criteria will be invited to participate. Before the patient signs the informed consent form the patients will receive written and oral information about the study as well as watch a video describing the trial and what participation will imply. Before the 4-day concentrated exposure based treatment (cET) starts, the patients will undergo a clinical assessment interview by the local OCD-team, and will watch another video describing the trial in detail. They will also be assessed by SCID-I (Structured Clinical Interview) for DSM 5 as well as Y-BOCS (Yale-Brown Obsessive Compulsive Scale) interview by independent and specially trained psychologists. The cET is delivered in an "individual group format" which implies that the patient: therapist-ratio is 1:1, and that the treatment is delivered in groups of minimum 3 and maximum 6 patients. All groups are led by a specially trained cET therapist, and the local therapists are experienced OCD-therapists who are familiar with the cET format. Day 1 of the treatment (3 h) consists of psychoeducation and planning of exposure tasks. Day 2 and day 3 (both 8 h + contact in the evening) consist of individually tailored and therapist assisted exposure with a number of relevant triggers in a diversity of settings. All exposures are based on the LEaning in Technique (LET), where the patients are trained to recognize when the urge to ritualize starts, and to actively approach the trigger by "leaning into the anxiety". The exposures are also designed to optimize learned inhibition. In addition to individual exposure training, the group meets three times throughout the day. Day 2 and Day 3 the patient will take study medication before the exposures start. The study medication is D-Cycloserine (DCS) 250 mg, DCS 100 mg or placebo. In the afternoon Day 3, the patients' relatives/ friends are invited to a 2 h lecture/ psychoeducation on OCD and the current treatment. Day 4 the focus is on "lessons learnt" as well as on planning / specifying exposure tasks for the coming three weeks. Before and during the cET the patient will record data electronically via CheckWare (an electronic case report form database). The patient will continue registration of obsessions and compulsions through 3 weeks post cET. One week after cET a post-assessment with Y-BOCS will be performed by the independent assessor. After 3 months, the patient is invited to an individual visit at the clinic. 1 year and 5 years post treatment, the assessment team will perform follow-up telephone interviews.
Measures of anxiety, depression, global functioning, severity of the disorder, self-reported OCD-symptoms, sleep, quality of life, changes in work and social status as well as changes in medication and use of health care will be included and employed as secondary outcomes.
A total of 14 expert therapists have been trained to deliver cET to OCD-patients all over Norway. Patients, therapists and assessors are all blinded to the randomization. Interventions are recorded and rated for compliance and competence . All SCID-I and Y-BOCS assessments are recorded and standard procedures for rescoring are followed. All assessors are independent and specially trained.
A Scientific Advisory Board is established, also including representatives from the Norwegian OCD-association. The formal project partners are Haukeland University Hospital; Oslo University Hospital; St Olavs Hospital; Soerlandet Hospital and Moere and Romsdal Hospital.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- D-Cycloserine, Placebo
- Keywords
- OCD
- 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, Cycloserine
Predicted to enhance stabilization of the effects of concentrated exposure treatment
PlaceboDrug
Also called Sugar Pill
Predicted to have no enhancing effect
| Study group | Role | What they receive |
|---|---|---|
| 250 mg DCS | Experimental | 64 patients receive 250 mg D-Cycloserine two consecutive days in combination with therapist assisted concentrated exposure therapy (cET) Receives: Drug: D-Cycloserine |
| 100 mg D-Cycloserine | Experimental | 64 patients receive 100 mg D-Cycloserine two consecutive days in combination with therapist assisted concentrated exposure therapy (cET) Receives: Drug: D-Cycloserine |
| Placebo | Active comparator | 32 patients receive placebo two consecutive days in combination with therapist assisted concentrated exposure therapy (cET) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Y-BOCS
Response is a ≥35% reduction of the individual patient's pre-treatment YBOCS score. A patient is remitted if the response criterion is fulfilled and the post-treatment Y-BOCS score is ≤12
Measured: 3 and 12 months, 5 years
Changes in diagnostic status
Changes in Diagnostic status (DSM-5) assessed by SCID-I for DSM-5 at above specified points.
Measured: 3 and 12 months, 5 years
Changes in Y-BOCS evaluated by Jacobson and Truax, Reliable Change Index (RCI)
The criteria of Jacobson and Truax: A.Change from pre- to post-assessment is statistically reliable at the 5%-level. (RCI). B. The patient's post-treatment score is within the distribution of the normal population defined as M+2Standard Deviation (SD), or outside the distribution of the patient population defined as M-2SD. Non-responder is not fulfilling the RCI. Partial responder fulfills the RCI but not the cut-off score Full responder fulfils the RCI and the cut-off score.
Measured: 3 and 12 months, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionSep 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Helse Vest
- Responsible party
- Sponsor
- Investigators
- Gerd Kvale, Principal investigator, Haukeland University HospitalBjarne Hansen, Principal investigator, Haukeland University HospitalMichelle Craske, PhD, Study chair, Haukeland University HospitalJonathan Abramowitz, PhD, Study chair, Haukeland University HospitalHime A Joeseph, PhD, Study chair, Haukeland University HospitalMartin D Franklin, PhD, Study chair, Haukeland University HospitalMichael Davis, PhD, Study chair, Haukeland University HospitalLars-Göran Öst, PhD, Study chair, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656342
- Sponsor's protocol ID
- 2013-002574-49
- Status last verified
- Feb 2021
- First submitted
- 30 Nov 2015
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Tjelle K, Hansen B, Solem S, Wheaton MG, Kvale G, Hagen K. Concentrated ERP for Patients With Difficult-to-Treat OCD: Insight as a Predictor of Acute and Long-Term Outcomes. Depress Anxiety. 2025 Dec 11;2025:8960147. doi: 10.1155/da/8960147. eCollection 2025.
PubMed 41425659Berg H, Tjelle K, Solem S, Hansen B, Kvale G, Bjorgvinsson T, Hagen K. Motivation in the Bergen 4-day treatment for obsessive-compulsive disorder. BMC Psychiatry. 2025 Oct 9;25(1):958. doi: 10.1186/s12888-025-07218-z.
PubMed 41068703Berg H, Tjelle K, Hansen B, Solem S, Bjorgvinsson T, Kvale G, Hagen K. Treatment expectancy and credibility as predictors of concentrated exposure treatment outcomes in patients with difficult-to-treat obsessive-compulsive disorder. BMC Psychiatry. 2025 Mar 25;25(1):275. doi: 10.1186/s12888-025-06737-z.
PubMed 40133857Tjelle K, Opstad HB, Solem S, Kvale G, Wheaton MG, Bjorgvinsson T, Hansen B, Hagen K. Patient adherence as a predictor of acute and long-term outcomes in concentrated exposure treatment for difficult-to-treat obsessive-compulsive disorder. BMC Psychiatry. 2024 Apr 30;24(1):327. doi: 10.1186/s12888-024-05780-6.
PubMed 38689256Kvale G, Hansen B, Hagen K, Abramowitz JS, Bortveit T, Craske MG, Franklin ME, Haseth S, Himle JA, Hystad S, Kristensen UB, Launes G, Lund A, Solem S, Ost LG. Effect of D-Cycloserine on the Effect of Concentrated Exposure and Response Prevention in Difficult-to-Treat Obsessive-Compulsive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2013249. doi: 10.1001/jamanetworkopen.2020.13249.
PubMed 32789516
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Approach to the Understanding and Treatment of Obsessive-Compulsive Disorder (OCD). Can D-Cycloserine Enhance and Stabilize the Treatment-response in Relapsed and Non-responding OCD-patients? A Randomized, Double-blind, Placebo-controlled National Study
- ClinicalTrials.gov ID
- NCT02656342
- Acronym / sponsor ID
- 2013-002574-49
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Helse Vest
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 14 Jan 2016 (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.
In this randomized controlled trial (RCT) the investigators experimentally test if patients with Obsessive-Compulsive Disorder (OCD) who have received treatment with exposure and response prevention (ERP), but either relapsed or not responded, profit from the combination of concentrated exposure based treatment (cET) and the NMDA-agonist (N-methyl-d-aspartate) d-cycloserine (DCS), targeting fear relevant areas in amygdala and pre-frontal cortex.
The project expects to demonstrate a significant improvement in all groups, and anticipate that a higher proportion of the patients who receive DCS will show a better long-term gain from the treatment, as compared to the placebo group at follow-up (3 mon, 12 mon, and 5 years after treatment). In addition, the project will highlight changes in depression, sleep, global functioning, quality of life, work and social status. Changes in medication and use of health care will be included and related to the main objective of the study.
Detailed description
A total of 160 relapsed and non-responding OCD-patients, treated with exposure and response prevention (ERP) in the specialist Health care in Norway, are planned to participate in the study: "Translation approach to the understanding and treatment of Obsessive-Compulsive Disorder (OCD). Can D-cycloserine (DCS) enhance and stabilize the treatment-response in relapsed and non-responding OCD-patients? A randomized, double-blind, placebo-controlled national study." Estimated start of inclusion is November 2015 and the inclusion period lasts for maximum 2 years. All participants are referred to the specialist health care and are pre-screen by the local OCD-team. Before inclusion, the patients will fill in a number of questionnaires on-line and all patients who meet the inclusion criteria will be invited to participate. Before the patient signs the informed consent form the patients will receive written and oral information about the study as well as watch a video describing the trial and what participation will imply. Before the 4-day concentrated exposure based treatment (cET) starts, the patients will undergo a clinical assessment interview by the local OCD-team, and will watch another video describing the trial in detail. They will also be assessed by SCID-I (Structured Clinical Interview) for DSM 5 as well as Y-BOCS (Yale-Brown Obsessive Compulsive Scale) interview by independent and specially trained psychologists. The cET is delivered in an "individual group format" which implies that the patient: therapist-ratio is 1:1, and that the treatment is delivered in groups of minimum 3 and maximum 6 patients. All groups are led by a specially trained cET therapist, and the local therapists are experienced OCD-therapists who are familiar with the cET format. Day 1 of the treatment (3 h) consists of psychoeducation and planning of exposure tasks. Day 2 and day 3 (both 8 h + contact in the evening) consist of individually tailored and therapist assisted exposure with a number of relevant triggers in a diversity of settings. All exposures are based on the LEaning in Technique (LET), where the patients are trained to recognize when the urge to ritualize starts, and to actively approach the trigger by "leaning into the anxiety". The exposures are also designed to optimize learned inhibition. In addition to individual exposure training, the group meets three times throughout the day. Day 2 and Day 3 the patient will take study medication before the exposures start. The study medication is D-Cycloserine (DCS) 250 mg, DCS 100 mg or placebo. In the afternoon Day 3, the patients' relatives/ friends are invited to a 2 h lecture/ psychoeducation on OCD and the current treatment. Day 4 the focus is on "lessons learnt" as well as on planning / specifying exposure tasks for the coming three weeks. Before and during the cET the patient will record data electronically via CheckWare (an electronic case report form database). The patient will continue registration of obsessions and compulsions through 3 weeks post cET. One week after cET a post-assessment with Y-BOCS will be performed by the independent assessor. After 3 months, the patient is invited to an individual visit at the clinic. 1 year and 5 years post treatment, the assessment team will perform follow-up telephone interviews.
Measures of anxiety, depression, global functioning, severity of the disorder, self-reported OCD-symptoms, sleep, quality of life, changes in work and social status as well as changes in medication and use of health care will be included and employed as secondary outcomes.
A total of 14 expert therapists have been trained to deliver cET to OCD-patients all over Norway. Patients, therapists and assessors are all blinded to the randomization. Interventions are recorded and rated for compliance and competence . All SCID-I and Y-BOCS assessments are recorded and standard procedures for rescoring are followed. All assessors are independent and specially trained.
A Scientific Advisory Board is established, also including representatives from the Norwegian OCD-association. The formal project partners are Haukeland University Hospital; Oslo University Hospital; St Olavs Hospital; Soerlandet Hospital and Moere and Romsdal Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 250 mg DCS | Experimental | Drug: D-Cycloserine64 patients receive 250 mg D-Cycloserine two consecutive days in combination with therapist assisted concentrated exposure therapy (cET) |
| 100 mg D-Cycloserine | Experimental | Drug: D-Cycloserine64 patients receive 100 mg D-Cycloserine two consecutive days in combination with therapist assisted concentrated exposure therapy (cET) |
| Placebo | Active comparator | Drug: Placebo32 patients receive placebo two consecutive days in combination with therapist assisted concentrated exposure therapy (cET) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Outpatients
- ≥ 18 years
- Fulfilling diagnostic criteria of OCD according to the DSM-5
- Previously have received ERP-treatment delivered by trained therapist and either have responded and relapsed, or not responded to the treatment.
- Response is defined by ≥35% reduction with a post-treatment Y-BOCS score of ≤15, followed by a relapse as defined by > 35% increase in Y-BOCS score from post-treatment, a Y-BOCS score of 16 or more, and a Clinical Global Impression-Improvement Scale (CGI-I) score of 6 ("much worse") or higher.
Key exclusion criteria (15 listed)
- OCD symptoms primarily associated with hoarding
- Ongoing substance abuse/dependence
- Bipolar disorder or psychosis
- Ongoing suicidal ideation
- Mental Retardation, based on previous medical history
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, CycloserinePredicted to enhance stabilization of the effects of concentrated exposure treatment | Drug | 100 mg D-Cycloserine, 250 mg DCS |
| PlaceboAlso: Sugar PillPredicted to have no enhancing effect | Drug | Placebo |
Primary outcome
Changes in Y-BOCS
Time frame: 3 and 12 months, 5 years
Response is a ≥35% reduction of the individual patient's pre-treatment YBOCS score. A patient is remitted if the response criterion is fulfilled and the post-treatment Y-BOCS score is ≤12
Changes in diagnostic status
Time frame: 3 and 12 months, 5 years
Changes in Diagnostic status (DSM-5) assessed by SCID-I for DSM-5 at above specified points.
Changes in Y-BOCS evaluated by Jacobson and Truax, Reliable Change Index (RCI)
Time frame: 3 and 12 months, 5 years
The criteria of Jacobson and Truax: A.Change from pre- to post-assessment is statistically reliable at the 5%-level. (RCI). B. The patient's post-treatment score is within the distribution of the normal population defined as M+2Standard Deviation (SD), or outside the distribution of the patient population defined as M-2SD. Non-responder is not fulfilling the RCI. Partial responder fulfills the RCI but not the cut-off score Full responder fulfils the RCI and the cut-off score.
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 11 Feb 2021.
- Derived from this study: PubMed 41425659Tjelle K, Hansen B, Solem S, Wheaton MG, Kvale G, Hagen K. Concentrated ERP for Patients With Difficult-to-Treat OCD: Insight as a Predictor of Acute and Long-Term Outcomes. Depress Anxiety. 2025 Dec 11;2025:8960147. doi: 10.1155/da/8960147. eCollection 2025.
- Derived from this study: PubMed 41068703Berg H, Tjelle K, Solem S, Hansen B, Kvale G, Bjorgvinsson T, Hagen K. Motivation in the Bergen 4-day treatment for obsessive-compulsive disorder. BMC Psychiatry. 2025 Oct 9;25(1):958. doi: 10.1186/s12888-025-07218-z.
- Derived from this study: PubMed 40133857Berg H, Tjelle K, Hansen B, Solem S, Bjorgvinsson T, Kvale G, Hagen K. Treatment expectancy and credibility as predictors of concentrated exposure treatment outcomes in patients with difficult-to-treat obsessive-compulsive disorder. BMC Psychiatry. 2025 Mar 25;25(1):275. doi: 10.1186/s12888-025-06737-z.
- Derived from this study: PubMed 38689256Tjelle K, Opstad HB, Solem S, Kvale G, Wheaton MG, Bjorgvinsson T, Hansen B, Hagen K. Patient adherence as a predictor of acute and long-term outcomes in concentrated exposure treatment for difficult-to-treat obsessive-compulsive disorder. BMC Psychiatry. 2024 Apr 30;24(1):327. doi: 10.1186/s12888-024-05780-6.
- Derived from this study: PubMed 32789516Kvale G, Hansen B, Hagen K, Abramowitz JS, Bortveit T, Craske MG, Franklin ME, Haseth S, Himle JA, Hystad S, Kristensen UB, Launes G, Lund A, Solem S, Ost LG. Effect of D-Cycloserine on the Effect of Concentrated Exposure and Response Prevention in Difficult-to-Treat Obsessive-Compulsive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2013249. doi: 10.1001/jamanetworkopen.2020.13249.
- Homepage for the OCD-team i nBergen and the national OCD-studyLink provided by the sponsor.
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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.
Gerd Kvale principal investigator
Haukeland University Hospital
Bjarne Hansen principal investigator
Haukeland University Hospital
Michelle Craske, PhD study chair
Haukeland University Hospital
14 sites 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 Haukeland University Hospital at 14 sites in Norway.
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 9 inclusion and 15 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Norway. 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. 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?
Changes in Y-BOCS (time frame: 3 and 12 months, 5 years). The study lists 3 primary outcomes in all. 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 NCT02656342, which also lists 5 linked publications.
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 11 Feb 2021.