Obsessive-Compulsive DisorderPhase 2NCT00758966
Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
A Phase 2 study testing Fluoxetine 60 mg, Naltrexone 32 mg and fluoxetine 60 mg and Naltrexone SR 32 mg in people with Obsessive-Compulsive Disorder, run by Orexigen Therapeutics, Inc at 11 sites in United States.
Trial summary
The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Fluoxetine 60 mg, Naltrexone 32 mg and fluoxetine 60 mg and Naltrexone SR 32 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2008to Dec 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects, 18 to 60 years of age (inclusive)
- Outpatients with a current diagnosis of OCD that have received previous therapy
- Negative serum pregnancy test as screening in women of child-bearing potential
- If a woman of child-bearing potential, must agreed to use an acceptable and effective form of contraception
- No clinically significant abnormality on electrocardiogram (ECG)
- No clinically significant laboratory abnormality at screening
- Negative urine drug screen
- Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule
Who cannot join
- Diagnosis of substance dependence
- Diagnosis of substance abuse (except for nicotine and caffeine)
- Serious or unstable medical illnesses
- Lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, anorexia nervosa, Pervasive Developmental Disorder (PDD), Asperger's Syndrome or the presence of antisocial or borderline personality disorder
- Diagnosis of tic disorder or Tourette's Syndrome
- Subjects diagnosed with impulse control disorder
Show all 9Show fewer
- Known sensitivity or allergic reaction to either naltrexone or fluoxetine
- Any condition which in the opinion of the investigator or Sponsor makes the subject unsuitable for inclusion in the study
- Immediate family of investigators, study personnel or Sponsor representatives
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Brooklyn Medical Institute
Brooklyn, New York, 11223
Northbrooke Research Center
Brown Deer, Wisconsin, 53223
Community Research
Cincinnati, Ohio, 45227
Carolina Clinical Research Services
Columbia, South Carolina, 29201
University of Florida, Department of Psychiatry
Gainesville, Florida, 32606
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Synergy Clinical Research
National City, California, 91950
Summit Research Network, Inc.
Portland, Oregon, 97210
Global Medical Institute, LLC
Princeton, New Jersey, 08540
California Clinical Trials
San Diego, California, 92123
About this study
Official title: A Proof-of-Concept, Multicenter, Randomized, Double-Blind, Parallel Study of Naltrexone Sustained-Release (SR) and/or Fluoxetine Therapy in the Treatment of Subjects With Obsessive-Compulsive Disorder (OCD)
The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Fluoxetine 60 mg, Naltrexone 32 mg and fluoxetine 60 mg, Naltrexone SR 32 mg
- Keywords
- OCD,, naltrexone,, fluoxetine,, obsessive-compulsive disorder
- 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.
Fluoxetine 60 mgDrug
Two week titration followed by daily dosing of fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on fluoxetine 60 mg for an additional 6 weeks. Non-responders will have naltrexone SR 32 mg added to their therapy.
Naltrexone 32 mg and fluoxetine 60 mgDrug
Two week titration followed by daily dosing of naltrexone SR 32 mg and fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on a daily dose of naltrexone SR 32 mg and fluoxetine 60 mg for an additional 6 weeks. Non-responders will have their daily dose adjusted to naltrexone SR 48 mg and fluoxetine 80 mg.
Naltrexone SR 32 mgDrug
Two week titration followed by daily dosing of naltrexone SR 32 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on naltrexone SR 32 mg for an additional 6 weeks. Non-responders will have fluoxetine 60 mg added to their therapy.
| Study group | Role | What they receive |
|---|---|---|
| NF (Naltrexone+Fluoxetine) | Experimental | Naltrexone SR 32 mg and fluoxetine 60 mg Receives: Drug: Naltrexone 32 mg and fluoxetine 60 mg |
| Fluoxetine | Active comparator | Fluoxetine 60 mg Receives: Drug: Fluoxetine 60 mg |
| Naltrexone | Active comparator | Naltrexone SR 32 mg Receives: Drug: Naltrexone SR 32 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the mean change from baseline to Week 10 in total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score between the combination treatment group versus fluoxetine alone and naltrexone SR alone
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Sponsor Decision- Financial Considerations
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey T Apter, MD, PA, Principal investigator, Global Medical Institutes, LLCWard Smith, MD, Principal investigator, Summit Research Network, Inc.Vishaal Mehra, MD, Principal investigator, California Clinical TrialsNaresh P Emmanuel, MD, Principal investigator, Carolina Clinical Research ServicesMohammad Bari, MD, Principal investigator, Synergy Clinical ResearchRobert Riesenberg, MD, Principal investigator, Atlanta Center for Medical ResearchTeresa Pigott, MD, Principal investigator, University of Florida, Dept Of PsychiatryAndrew W Goddard, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758966
- Sponsor's protocol ID
- NF-101
- Status last verified
- Nov 2012
- First submitted
- 22 Sep 2008
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept, Multicenter, Randomized, Double-Blind, Parallel Study of Naltrexone Sustained-Release (SR) and/or Fluoxetine Therapy in the Treatment of Subjects With Obsessive-Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT00758966
- Acronym / sponsor ID
- NF-101
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD,, naltrexone,, fluoxetine,, obsessive-compulsive disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision- Financial Considerations
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Sep 2008 (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 determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NF (Naltrexone+Fluoxetine) | Experimental | Drug: Naltrexone 32 mg and fluoxetine 60 mgNaltrexone SR 32 mg and fluoxetine 60 mg |
| Fluoxetine | Active comparator | Drug: Fluoxetine 60 mgFluoxetine 60 mg |
| Naltrexone | Active comparator | Drug: Naltrexone SR 32 mgNaltrexone SR 32 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female subjects, 18 to 60 years of age (inclusive)
- Outpatients with a current diagnosis of OCD that have received previous therapy
- Negative serum pregnancy test as screening in women of child-bearing potential
- If a woman of child-bearing potential, must agreed to use an acceptable and effective form of contraception
- No clinically significant abnormality on electrocardiogram (ECG)
Key exclusion criteria (9 listed)
- Diagnosis of substance dependence
- Diagnosis of substance abuse (except for nicotine and caffeine)
- Serious or unstable medical illnesses
- Lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, anorexia nervosa, Pervasive Developmental Disorder (PDD), Asperger's Syndrome or the presence of antisocial or borderline personality disorder
- Diagnosis of tic disorder or Tourette's Syndrome
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 |
|---|---|---|
| Fluoxetine 60 mgTwo week titration followed by daily dosing of fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on fluoxetine 60 mg for an additional 6 weeks. Non-responders will have naltrexone SR 32 mg added to their therapy. | Drug | Fluoxetine |
| Naltrexone 32 mg and fluoxetine 60 mgTwo week titration followed by daily dosing of naltrexone SR 32 mg and fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on a daily dose of naltrexone SR 32 mg and fluoxetine 60 mg for an additional 6 weeks. Non-responders will have their daily dose adjusted to naltrexone SR 48 mg and fluoxetine 80 mg. | Drug | NF (Naltrexone+Fluoxetine) |
| Naltrexone SR 32 mgTwo week titration followed by daily dosing of naltrexone SR 32 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on naltrexone SR 32 mg for an additional 6 weeks. Non-responders will have fluoxetine 60 mg added to their therapy. | Drug | Naltrexone |
Primary outcome
Evaluate the mean change from baseline to Week 10 in total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score between the combination treatment group versus fluoxetine alone and naltrexone SR alone
Time frame: Baseline to Week 10
Results and safety
The study was stopped early (reason given: Sponsor Decision- Financial Considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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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.
Jeffrey T Apter, MD, PA principal investigator
Global Medical Institutes, LLC
Ward Smith, MD principal investigator
Summit Research Network, Inc.
Vishaal Mehra, MD principal investigator
California Clinical Trials
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxetine 60 mg, Naltrexone 32 mg and fluoxetine 60 mg and Naltrexone SR 32 mg in people with Obsessive-Compulsive Disorder, run by Orexigen Therapeutics, Inc at 11 sites 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 8 inclusion and 9 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 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
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: Sponsor Decision- Financial Considerations). 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?
Evaluate the mean change from baseline to Week 10 in total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score between the combination treatment group versus fluoxetine alone and naltrexone SR alone (time frame: Baseline to Week 10). 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 29 Nov 2012.