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

Orexigen

Status and phase: Terminated; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Naltrexone SR 32 mg; Drug: Fluoxetine 60 mg; Drug: Naltrexone 32 mg and fluoxetine 60 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758966

NF-101

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 3 patient groups

NF (Naltrexone+Fluoxetine)

Experimental group

Description:

Naltrexone SR 32 mg and fluoxetine 60 mg

Treatment:

Drug: Naltrexone 32 mg and fluoxetine 60 mg

Fluoxetine

Active Comparator group

Description:

Fluoxetine 60 mg

Treatment:

Drug: Fluoxetine 60 mg

Naltrexone

Active Comparator group

Description:

Naltrexone SR 32 mg

Treatment:

Drug: Naltrexone SR 32 mg