Study of Fluoxetine in Patients With Depersonalization Disorder

National Institute of Mental Health (NIMH)1 site in 1 country80 target enrollmentApril 1998

ConditionsDepersonalization Disorder

Drugsfluoxetine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depersonalization Disorder
Sponsor: National Institute of Mental Health (NIMH)
Enrollment: 80
Locations: 1
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to:

Determine the effects of fluoxetine in the treatment of depersonalization disorder, 2) Assess the durability of treatment response in these patients, 3) Assess the improvement in psychiatric disability in these patients, and 4) Assess the effects of comorbid Axis I disorders (depression, social phobia, panic/anxiety, obsessive-compulsive disorder) and Axis II personality disorders on treatment outcome in these patients.

Detailed Description

In this trial, participants will be randomly assigned to receive either fluoxetine or placebo. Treatment will consists of two phases (acute treatment and maintenance). In the acute treatment phase, participants will receive fluoxetine or placebo daily for 12 weeks. Participants will be followed every 2 weeks. In the Maintenance phase, participants showing significant improvement after 12 weeks may continue treatment for an additional 6 months. In this phase, participants are followed every 4 weeks. Participants who do not improve during the acute treatment phase may receive open fluoxetine, or another appropriate medication, for 3 months.

Registry

clinicaltrials.gov

Start Date

April 1998

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

National Institute of Mental Health (NIMH)

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Prior or concurrent bio- or chemotherapy or
•Use of any of the following within 2 weeks prior to study entry: antipsychotics, anticonvulsants, stimulants, barbiturates, lithium, benzodiazepines, or antidepressants
•Use of MAO inhibitors or investigational drugs within 4 weeks prior to study entry
•History of fluoxetine use at a dose of 10 mg or more for at least 6 weeks duration
•Hematologic, hepatic, renal, cardiovascular, pulmonary, metabolic, endocrine, systemic, or gastrointestinal disease
•History of mental disorders
•Current substance abuse
•Current eating disorder
•Current clinically unstable suicidal ideation
•Unstable medical illness