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

Primary Purpose

Obsessive-Compulsive Disorder

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fluoxetine 60 mg

Naltrexone 32 mg and fluoxetine 60 mg

Naltrexone SR 32 mg

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD,, naltrexone,, fluoxetine,, obsessive-compulsive disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

NF (Naltrexone+Fluoxetine)

Fluoxetine

Naltrexone

Arm Description

Naltrexone SR 32 mg and fluoxetine 60 mg

Fluoxetine 60 mg

Naltrexone SR 32 mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00758966

First Posted

September 22, 2008

Last Updated

November 27, 2012

Sponsor

Orexigen Therapeutics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00758966

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor Decision- Financial Considerations

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Orexigen Therapeutics, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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 alone or naltrexone SR alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

Keywords

OCD,, naltrexone,, fluoxetine,, obsessive-compulsive disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NF (Naltrexone+Fluoxetine)

Arm Type

Experimental

Arm Description

Naltrexone SR 32 mg and fluoxetine 60 mg

Arm Title

Fluoxetine

Arm Type

Active Comparator

Arm Description

Fluoxetine 60 mg

Arm Title

Naltrexone

Arm Type

Active Comparator

Arm Description

Naltrexone SR 32 mg

Intervention Type

Drug

Intervention Name(s)

Fluoxetine 60 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Naltrexone 32 mg and fluoxetine 60 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Naltrexone SR 32 mg

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: