Obsessive Compulsive DisorderNCT01172873
D-Cycloserine Augmentation to CBT With Exposure and Response Prevention in Adults and Adolescents With OCD
A study testing D-cycloserine and Exposure and Response Prevention (EX/RP) in people with Obsessive Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This is a single site, open-label, feasibility study of cognitive behavioral therapy with exposure and response prevention (CBT/ERP) adding the augmentation of D-cycloserine (DCS) for adolescents ages 12-17 with Obsessive Compulsive Disorder (OCD) who are partial or non-responders to first line treatments of CBT or… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- D-cycloserine and Exposure and Response Prevention (EX/RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must be ages of 12-17 at the time of consent.
- Both patients and parents must be able to speak and understand English.
- Written informed assent by the patient and consent by the parent.
- Ability and willingness to comply with study treatment and to attend study assessments.
- Patients must be physically healthy males or non-pregnant females. Females of childbearing potential must comply with contraceptive restrictions noted in the protocol.
- Patients must fulfill Diagnostic and Statistical Manual (DSM-IV) criteria for OCD, and OCD must be the primary disorder with a CY-BOCS score > 16
Show all 10Show fewer
- For patients with attention-deficit hyperactivity disorder (ADHD), the condition must be stable for 4 weeks on present treatment prior to screening.
- For patients receiving treatment with an FDA approved Serotonin Reuptake Inhibitor (SRI), the medication dose must be stable for at least 12 weeks prior to enrollment.
- Patients who failed to respond to either CBT/ERP treatment or a SRI medication (as evidenced by a CY-BOCS score > 16).
- Based on history, the patient is unlikely to require a change in medication during the course of CBT/ERP + DCS treatment.
Who cannot join
- Patients with any clinically significant abnormalities in laboratory parameters at screening.
- Clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (for example, severe asthma, uncontrolled diabetes mellitus).
- History of schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to DSM-IV criteria (using the Anxiety Disorders Interview Schedule (ADIS-R) assessment interview), except for patients with a diagnosis of ADHD and/or other anxiety disorders as secondary diagnoses.
- Patients who have a history suggestive of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infection (PANDAS). - i.e., a sudden onset or exacerbation of symptoms temporally associated with a preceding streptococcal infection with first onset prior to puberty.
- Patients who are receiving formal psychotherapy, other than the one delivered in the study, whether or not the focus of the therapy is on their OCD.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute/Columbia University
New York, New York, 10032
About this study
Official title: Open-Label Exploratory Investigation of D-Cycloserine Augmentation to Cognitive Behavioral Therapy With Exposure and Response Prevention for Adults and Adolescents Diagnosed With Obsessive Compulsive Disorder - A Feasibility Study
This is a single site, open-label, feasibility study of cognitive behavioral therapy with exposure and response prevention (CBT/ERP) adding the augmentation of D-cycloserine (DCS) for adolescents ages 12-17 with Obsessive Compulsive Disorder (OCD) who are partial or non-responders to first line treatments of CBT or pharmacotherapy.
Read the detailed description
The primary goal of this study is to examine the feasibility and efficacy of DCS augmentation to CBT/ERP at the end of the session. The main treatment outcome will be measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The secondary goal of the study is to investigate the safety of DCS in adolescents with OCD. 18 adolescents will be recruited in this study. Patients who are currently on medication therapies for OCD must be stable for at least 12 weeks prior to and during the study.
This study consists of a screening period that contains a 90-minute psycho-educational session and treatment period of up to 5 weeks. During the treatment period, patients will receive ten 60-minute CBT/ERP sessions held twice weekly. At the end of each session, patients will receive a 50 mg dose of DCS. Following the administration of the DCS, patients will be asked to do their best not to ritualize and remain on the Children's Day Unit, where they will be observed and report to the research team if any ritualization has occurred. At the end of study participation, all participants will be offered 10 additional sessions of twice-weekly ERP without DCS administration. All participants will then complete a follow-up visit at 10 weeks after baseline.
The main treatment outcome will be measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The secondary goal of the study is to investigate the safety of DCS in adolescents with OCD. Additionally, we will explore the impact of patient's motivation to change, parental pathology, and family accommodation on the treatment progress and outcome in adolescents.
Present data collected from this protocol show that adolescents who completed and engaged in treatment experienced benefit to the combination of CBT/ERP and DCS. However, this is an unblinded study and the adolescents are receiving an intensive form of CBT/ERP with close monitoring following 2 hours after the administration of the DCS. The positive results may be due to this specific way in which the CBT/ERP was delivered or to the attention paid to participants during treatment sessions and monitoring periods. We recruited 5 additional adolescents diagnosed with OCD to serve as control group participants. These individuals all had a history of failed or partial response to at least one trial of Selective Serotonin Reuptake Inhibitor (SSRI) medication or CBT/ERP. These participants also received ten sessions of twice weekly CBT/ERP delivered exactly as it was previously in this protocol, but without DCS administration. All control participants completed a follow-up visit at 10 weeks after baseline. Due to the small number of control participants, statistical analyses comparing the treatment groups were not completed.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- D-cycloserine, Exposure and Response Prevention (EX/RP)
- Keywords
- OCD, DCS, D-cycloserine, CBT, E/RP, exposure response prevention
- 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
50 mg dose of D-cycloserine administered at the end of each session of Cognitive Behavioral Therapy With Exposure and Response Prevention: twice weekly CBT/ERP of 60 minutes
Exposure and Response Prevention (EX/RP)Behavioural
Exposure and response prevention treatment. Participants complete graded exposure during twice weekly treatment sessions with therapist
| Study group | Role | What they receive |
|---|---|---|
| DCS + Exposure and Response Prevention | Active comparator | Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held. Receives: Drug: D-cycloserine; Behavioral: Exposure and Response Prevention (EX/RP) |
| E/RP alone (no DCS administration) | Active comparator | Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions. Receives: Drug: D-cycloserine; Behavioral: Exposure and Response Prevention (EX/RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents
The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.
Measured: baseline, visit 5, visit 10, follow-up visit
Secondary outcomes (2)
Multidimensional Anxiety Scale for Children (MASC)
Multidimensional Anxiety Scale for Children (MASC): This is a 39-item self-report that measures anxiety symptoms. It provides a total score, as well as 10 subscales, although only total scores will be analyzed. MASC scores range from 0-117, with higher scores representing greater severity of anxiety symptoms. The MASC and will be administered at baseline, session 5, session 10 and the follow-up visit for adolescents.
Measured: baseline, visit 5, visit 10, follow-up visit
Beck Depression Inventory (BDI)
Beck's Depression Inventory (BDI): This is a 21-item self report that measures depression symptoms and will be used for both adults and adolescents at baseline, session 5, session 10 and the follow-up visit. BDI-II scores range from 0-63, with higher scores representing greater severity of depression symptoms.
Measured: baseline, visit 5, visit 10, follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Moira A Rynn, M.D., Principal investigator, NYSPI / CU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172873
- Sponsor's protocol ID
- #5828
- Status last verified
- Jan 2014
- First submitted
- 20 Apr 2009
- Last updated
- 19 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Exploratory Investigation of D-Cycloserine Augmentation to Cognitive Behavioral Therapy With Exposure and Response Prevention for Adults and Adolescents Diagnosed With Obsessive Compulsive Disorder - A Feasibility Study
- ClinicalTrials.gov ID
- NCT01172873
- Acronym / sponsor ID
- #5828
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- OCD, DCS, D-cycloserine, CBT, E/RP, exposure response prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Posted 23 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single site, open-label, feasibility study of cognitive behavioral therapy with exposure and response prevention (CBT/ERP) adding the augmentation of D-cycloserine (DCS) for adolescents ages 12-17 with Obsessive Compulsive Disorder (OCD) who are partial or non-responders to first line treatments of CBT or pharmacotherapy.
Detailed description
The primary goal of this study is to examine the feasibility and efficacy of DCS augmentation to CBT/ERP at the end of the session. The main treatment outcome will be measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The secondary goal of the study is to investigate the safety of DCS in adolescents with OCD. 18 adolescents will be recruited in this study. Patients who are currently on medication therapies for OCD must be stable for at least 12 weeks prior to and during the study.
This study consists of a screening period that contains a 90-minute psycho-educational session and treatment period of up to 5 weeks. During the treatment period, patients will receive ten 60-minute CBT/ERP sessions held twice weekly. At the end of each session, patients will receive a 50 mg dose of DCS. Following the administration of the DCS, patients will be asked to do their best not to ritualize and remain on the Children's Day Unit, where they will be observed and report to the research team if any ritualization has occurred. At the end of study participation, all participants will be offered 10 additional sessions of twice-weekly ERP without DCS administration. All participants will then complete a follow-up visit at 10 weeks after baseline.
The main treatment outcome will be measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The secondary goal of the study is to investigate the safety of DCS in adolescents with OCD. Additionally, we will explore the impact of patient's motivation to change, parental pathology, and family accommodation on the treatment progress and outcome in adolescents.
Present data collected from this protocol show that adolescents who completed and engaged in treatment experienced benefit to the combination of CBT/ERP and DCS. However, this is an unblinded study and the adolescents are receiving an intensive form of CBT/ERP with close monitoring following 2 hours after the administration of the DCS. The positive results may be due to this specific way in which the CBT/ERP was delivered or to the attention paid to participants during treatment sessions and monitoring periods. We recruited 5 additional adolescents diagnosed with OCD to serve as control group participants. These individuals all had a history of failed or partial response to at least one trial of Selective Serotonin Reuptake Inhibitor (SSRI) medication or CBT/ERP. These participants also received ten sessions of twice weekly CBT/ERP delivered exactly as it was previously in this protocol, but without DCS administration. All control participants completed a follow-up visit at 10 weeks after baseline. Due to the small number of control participants, statistical analyses comparing the treatment groups were not completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCS + Exposure and Response Prevention | Active comparator | Drug: D-cycloserine, Behavioral: Exposure and Response Prevention (EX/RP)Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held. |
| E/RP alone (no DCS administration) | Active comparator | Drug: D-cycloserine, Behavioral: Exposure and Response Prevention (EX/RP)Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Patients must be ages of 12-17 at the time of consent.
- Both patients and parents must be able to speak and understand English.
- Written informed assent by the patient and consent by the parent.
- Ability and willingness to comply with study treatment and to attend study assessments.
- Patients must be physically healthy males or non-pregnant females. Females of childbearing potential must comply with contraceptive restrictions noted in the protocol.
Key exclusion criteria (5 listed)
- Patients with any clinically significant abnormalities in laboratory parameters at screening.
- Clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (for example, severe asthma, uncontrolled diabetes mellitus).
- History of schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to DSM-IV criteria (using the Anxiety Disorders Interview Schedule (ADIS-R) assessment interview), except for patients with a diagnosis of ADHD and/or other anxiety disorders as secondary diagnoses.
- Patients who have a history suggestive of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infection (PANDAS). - i.e., a sudden onset or exacerbation of symptoms temporally associated with a preceding streptococcal infection with first onset prior to puberty.
- Patients who are receiving formal psychotherapy, other than the one delivered in the study, whether or not the focus of the therapy is on their OCD.
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-cycloserine50 mg dose of D-cycloserine administered at the end of each session of Cognitive Behavioral Therapy With Exposure and Response Prevention: twice weekly CBT/ERP of 60 minutes | Drug | DCS + Exposure and Response Prevention, E/RP alone (no DCS administration) |
| Exposure and Response Prevention (EX/RP)Exposure and response prevention treatment. Participants complete graded exposure during twice weekly treatment sessions with therapist | Behavioural | DCS + Exposure and Response Prevention, E/RP alone (no DCS administration) |
Primary outcome
Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents
Time frame: baseline, visit 5, visit 10, follow-up visit
The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.
2 secondary outcomes
Multidimensional Anxiety Scale for Children (MASC)
Time frame: baseline, visit 5, visit 10, follow-up visit
Beck Depression Inventory (BDI)
Time frame: baseline, visit 5, visit 10, follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obsessive Compulsive Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
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.
Moira A Rynn, M.D. principal investigator
NYSPI / CU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-cycloserine and Exposure and Response Prevention (EX/RP) in people with Obsessive Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
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 10 inclusion and 5 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 19 Aug 2014. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents (time frame: baseline, visit 5, visit 10, follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2014.