Status:
TERMINATED
Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
Lead Sponsor:
Orexigen Therapeutics, Inc
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 alo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00758966
Start Date
September 1 2008
End Date
December 1 2008
Last Update
November 29 2012
Active Locations (11)
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1
Synergy Clinical Research
National City, California, United States, 91950
2
California Clinical Trials
San Diego, California, United States, 92123
3
University of Florida, Department of Psychiatry
Gainesville, Florida, United States, 32606
4
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308