Obsessive Compulsive DisorderPhase 2OCDNCT00997087
A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder
A Phase 2 study testing Flumazenil in people with Obsessive Compulsive Disorder, run by Parkway Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD). Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Flumazenil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2012
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to understand and provide written informed consent.
- Age 19-60, inclusive.
- Diagnosis documented according to DSM-IV of OCD.
- Exhibits moderate to severe OCD symptoms and a minimum score of 16 or greater -YBOCS at screening.
- Willing and able to discontinue current medications taken for the treatment of OCD.
- Able to attend and participate in all study visits.
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- Agree to continue if in current psychosocial therapy throughout the remainder of the study.
- If female and of child-bearing potential, willing to use an acceptable method of birth control for the duration of the study.
- If male, willing to use barrier method of birth control or had previous vasectomy.
Who cannot join
- Have other DSM-IV Axis I diagnoses.
- Pregnant as confirmed by urine analysis, or lactating, or unwilling to comply with use of contraception.
- Unwilling or unable to washout (discontinue) from prohibited medications such as antidepressants (See Appendix 2).
- Depression symptoms with a score of 15 or greater on the MADRS at screening.
- Current suicidal ideation or plan within the last 30 days.
- Have a medical condition which, in the opinion of the investigator, makes study participation unsafe or noncompliant.
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- Abnormal physical exam or laboratory values which, in the opinion of the investigator, makes study participation unsafe or may require introduction of concomitant medications during the course of the study.
- Benzodiazepine and/or similar sedative-hypnotic or anxiolytic use or abuse within 15 days of potential flumazenil treatment: patients must not be habituated to benzodiazepines and must provide a urine sample that is negative for benzodiazepines, must not be taking supra-therapeutic doses of zolpidem (AmbienTM) or zaleplon (SonataTM ). (See Appendix 2).
- Patients who are taking Phenobarbital for a documented seizure disorder can be admitted. Patients with a seizure disorder being managed with clonazepam (KlonopinTM ) or other benzodiazepine cannot participate, patients must not be taking TCA, lithium, methylxanthines, isoniazid, propoxyphene, monoamine oxidase inhibitors, bupropion HCL, and cyclosporine. (See Appendix 2).
- Previously treated with flumazenil for OCD.
- AIDS as determined by self-report.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIa A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder.
The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD).
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Flumazenil
- 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.
FlumazenilDrug
Sublingual daily
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill, Placebo | Placebo comparator | Not described Receives: Drug: Flumazenil |
| Flumazenil | Active comparator | Not described Receives: Drug: Flumazenil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Score
Measured: 12 weeks
Secondary outcomes (1)
Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Study completed and data was inconclusive.
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkway Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James G.Sullivan, MD, Parkway Medical Center
- Investigators
- James G Sullivan, MD, Principal investigator, Parkway Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997087
- Sponsor's protocol ID
- JGS-001
- Acronym
- OCD
- Status last verified
- Apr 2014
- First submitted
- 14 Oct 2009
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder.
- ClinicalTrials.gov ID
- NCT00997087
- Acronym / sponsor ID
- OCD / JGS-001
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- OCD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study completed and data was inconclusive.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Parkway Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Oct 2009 (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 evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill, Placebo | Placebo comparator | Drug: Flumazenil |
| Flumazenil | Active comparator | Drug: Flumazenil |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able to understand and provide written informed consent.
- Age 19-60, inclusive.
- Diagnosis documented according to DSM-IV of OCD.
- Exhibits moderate to severe OCD symptoms and a minimum score of 16 or greater -YBOCS at screening.
- Willing and able to discontinue current medications taken for the treatment of OCD.
Key exclusion criteria (11 listed)
- Have other DSM-IV Axis I diagnoses.
- Pregnant as confirmed by urine analysis, or lactating, or unwilling to comply with use of contraception.
- Unwilling or unable to washout (discontinue) from prohibited medications such as antidepressants (See Appendix 2).
- Depression symptoms with a score of 15 or greater on the MADRS at screening.
- Current suicidal ideation or plan within the last 30 days.
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 |
|---|---|---|
| FlumazenilSublingual daily | Drug | Flumazenil, Sugar Pill, Placebo |
Primary outcome
Yale Brown Obsessive Compulsive Score
Time frame: 12 weeks
1 secondary outcome
Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Study completed and data was inconclusive.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
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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.
James G Sullivan, MD principal investigator
Parkway Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flumazenil in people with Obsessive Compulsive Disorder, run by Parkway Medical Center 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 Apr 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. 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 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 stopped early (reason given: Study completed and data was inconclusive.). Results are not available in the source record.
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 Score (time frame: 12 weeks). 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 22 Apr 2014.