Trial | NCT00758966  Report issue

Title

Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    naltrexone fluoxetine ...

  • Study Participants

    8
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 Started
Sep 30
2008
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
Nov 29
2012
Estimate

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.

Drug 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.

Drug 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.

NF (Naltrexone+Fluoxetine) Experimental

Naltrexone SR 32 mg and fluoxetine 60 mg

Fluoxetine Active Comparator

Fluoxetine 60 mg

Naltrexone Active Comparator

Naltrexone SR 32 mg

Criteria 

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
No Results Posted