Obsessive Compulsive DisorderPhase 2NCT00257361
D-Cycloserine Augmentation of Exposure and Response Prevention Treatment for Obsessive-Compulsive Disorder
A Phase 2 study testing D-Cycloserine in people with Obsessive Compulsive Disorder, run by University of Florida.
Trial summary
We propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- D-Cycloserine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to not given
- Phase
- Phase 2
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- a principal diagnosis of OCD assigned at pre-treatment, derived from the ADIS-IV, with a clinical severity rating of 4 or above;
- 18-65 years of age; and,
- an IQ of ³ 80.
Who cannot join
- positive diagnosis of schizophrenia, other psychotic disorder, pervasive developmental disorder, organic brain syndrome, or mental retardation;
- do not speak English;
- are unwilling to attend twice weekly sessions; or,
- is pregnant, breast feeding a child, or attempting to become pregnant (see below rationale)
About this study
We propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD.
Read the detailed description
Exposure and response prevention (ERP) has proven efficacy for OCD treatment in adults. Yet, ERP does not help all individuals, and those who benefit often remain somewhat symptomatic. Behavioral models for OCD treatment are based on two components. First, fears are acquired by the development of an association between a neutral stimulus and an aversive stimulus such the former acquires the aversive properties of the latter. The neutral stimulus is then designated as a conditioned stimulus (CS), and the original aversive stimulus is called an unconditioned stimulus (UCS). Second, the acquired fears can be unlearned through presentation of the CS in the absence of the UCS, a process known as extinction. On a neural level, ERP incorporates similar mechanisms to those involved in fear conditioning. Antagonists at the glutamatergic NMDA receptor, which is involved in learning and memory, block both fear learning and extinction. D-Cycloserine (DCS), a partial agonist at the N-methyl-D-aspartate (NMDA) glutamate receptor subtype, augments learning in animals and humans. Clinical application in animals and humans suggest that DCS facilitates the fear extinction process when taken prior to exposure to feared stimuli. An initial trial in acrophobic adults provided support for acute DCS dosing as facilitating extinction to fear. Given that ERP is based on extinction, it follows that DCS may augment ERP therapy providing enhanced treatment effects. With this in mind, we propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
YBOCS
Secondary outcomes (1)
Response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startJul 2005
Why it stopped: PI left the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Obsessive Compulsive Foundation
- Responsible party
- Sponsor
- Investigators
- Eric Storch, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257361
- Sponsor's protocol ID
- IRB Protocol #639-2004
- Other IDs
- 00053428
- Status last verified
- Aug 2011
- First submitted
- 18 Nov 2005
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-Cycloserine Augmentation of Exposure and Response Prevention Treatment for Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00257361
- Acronym / sponsor ID
- IRB Protocol #639-2004
- Conditions
- Obsessive Compulsive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Obsessive Compulsive Foundation
- Study start
- Jul 2005
- First posted
- 22 Nov 2005 (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.
We propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD.
Detailed description
Exposure and response prevention (ERP) has proven efficacy for OCD treatment in adults. Yet, ERP does not help all individuals, and those who benefit often remain somewhat symptomatic. Behavioral models for OCD treatment are based on two components. First, fears are acquired by the development of an association between a neutral stimulus and an aversive stimulus such the former acquires the aversive properties of the latter. The neutral stimulus is then designated as a conditioned stimulus (CS), and the original aversive stimulus is called an unconditioned stimulus (UCS). Second, the acquired fears can be unlearned through presentation of the CS in the absence of the UCS, a process known as extinction. On a neural level, ERP incorporates similar mechanisms to those involved in fear conditioning. Antagonists at the glutamatergic NMDA receptor, which is involved in learning and memory, block both fear learning and extinction. D-Cycloserine (DCS), a partial agonist at the N-methyl-D-aspartate (NMDA) glutamate receptor subtype, augments learning in animals and humans. Clinical application in animals and humans suggest that DCS facilitates the fear extinction process when taken prior to exposure to feared stimuli. An initial trial in acrophobic adults provided support for acute DCS dosing as facilitating extinction to fear. Given that ERP is based on extinction, it follows that DCS may augment ERP therapy providing enhanced treatment effects. With this in mind, we propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a principal diagnosis of OCD assigned at pre-treatment, derived from the ADIS-IV, with a clinical severity rating of 4 or above;
- 18-65 years of age; and,
- an IQ of ³ 80.
Key exclusion criteria (4 listed)
- positive diagnosis of schizophrenia, other psychotic disorder, pervasive developmental disorder, organic brain syndrome, or mental retardation;
- do not speak English;
- are unwilling to attend twice weekly sessions; or,
- is pregnant, breast feeding a child, or attempting to become pregnant (see below rationale)
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-Cycloserine | Drug | – |
Primary outcome
YBOCS
1 secondary outcome
Response rate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
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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.
Eric Storch, Ph.D. principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-Cycloserine in people with Obsessive Compulsive Disorder, run by University of Florida.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
YBOCS. 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 30 Sep 2013.