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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00758966
Other study ID # NF-101
Secondary ID
Status Terminated
Phase Phase 2
First received September 22, 2008
Last updated November 27, 2012
Start date September 2008
Est. completion date December 2008

Study information

Verified date November 2012
Source Orexigen Therapeutics, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Fluoxetine 60 mg
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 mg
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 mg
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.

Locations

Country Name City State
United States Atlanta Center for Medical Research Atlanta Georgia
United States Brooklyn Medical Institute Brooklyn New York
United States Northbrooke Research Center Brown Deer Wisconsin
United States Community Research Cincinnati Ohio
United States Carolina Clinical Research Services Columbia South Carolina
United States University of Florida, Department of Psychiatry Gainesville Florida
United States Indiana University School of Medicine Indianapolis Indiana
United States Synergy Clinical Research National City California
United States Summit Research Network, Inc. Portland Oregon
United States Global Medical Institute, LLC Princeton New Jersey
United States California Clinical Trials San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Orexigen Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline to Week 10 No
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