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.

Condition	Treatment or Intervention
Depersonalization Disorder	Drug: fluoxetine

Further Study Details: 

Expected Total Enrollment:  80

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusioin Criteria:

• Meets DSM-IV criteria for depersonalization disorder in the last month

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
• Clinically unstable
• Clinically important abnormalities in lab tests or physical exams
• History of seizure disorders or abnormal electroencephalogram
• Hypersensitivity or severe side effects to fluoxetine
• Pregnancy or breast-feeding. Women of child-bearing potential must use effective contraception

New York
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States

Study chairs or principal investigators

Daphne Simeon,  Study Chair,  Mount Sinai Medical Center   

Study ID Numbers:  199/13456; MTS-GCO-95-323
Record last reviewed:  March 2005
Last Updated:  March 18, 2005
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004446
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08