Clinical trial NCT00004446: Study of Fluoxetine in Patients With Depersonalization Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depersonalization Disorder
Keywords: depersonalization disorder
neurologic and psychiatric disorders
rare disease
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 1999-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center, NY
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Daphne Simeon
role: STUDY_CHAIR
References:
citation: Simeon D, Guralnik O, Schmeidler J, Knutelska M. Fluoxetine therapy in depersonalisation disorder: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:31-6. doi: 10.1192/bjp.185.1.31.