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
| Type | Name | Description |
|---|---|---|
| DRUG | fluoxetine |
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.