Clinical Trials Directory

Trials / Completed

CompletedNCT00004446

Study of Fluoxetine in Patients With Depersonalization Disorder

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (planned)
Sponsor
National Institute of Mental Health (NIMH) · NIH
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to: 1\) 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.

Conditions

Interventions

TypeNameDescription
DRUGfluoxetine

Timeline

Start date
1998-04-01
First posted
1999-10-19
Last updated
2005-06-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00004446. Inclusion in this directory is not an endorsement.

Study of Fluoxetine in Patients With Depersonalization Disorder (NCT00004446) · Clinical Trials Directory