Study of Fluoxetine in Patients With Depersonalization Disorder

Study Overview
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Brief Summary
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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
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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
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Depersonalization Disorder

Intervention / Treatment
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* Drug: fluoxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluoxetine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depersonalization disorder, neurologic and psychiatric disorders, rare disease