Study of Fluoxetine in Patients With Depersonalization Disorder

Depersonalization Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004446
• Other study ID #: 199/13456
• Secondary ID: MTS-GCO-95-323
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: April 1998

Study information

• Verified date: March 2005
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depersonalization
• Depersonalization Disorder

Intervention

Drug:
• fluoxetine

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center, NY	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (1)

Simeon D, Guralnik O, Schmeidler J, Knutelska M. Fluoxetine therapy in depersonalisation disorder: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:31-6. — View Citation