Study of Fluoxetine in Patients With Depersonalization Disorder
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depersonalization Disorder
Intervention: fluoxetine (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Daphne Simeon, Study Chair, Affiliation: Mount Sinai School of Medicine
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): 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
Locations and Contacts
Mount Sinai Medical Center, NY, New York, New York 10029, United States
Additional Information
Related publications: Simeon D, Guralnik O, Schmeidler J, Knutelska M. Fluoxetine therapy in depersonalisation disorder: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:31-6.
Starting date: April 1998
Last updated: June 23, 2005
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