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Study of Fluoxetine in Patients With Depersonalization Disorder
This study has been completed.
Study NCT00004446   Information provided by National Institute of Mental Health (NIMH)
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes

October 18, 1999
June 23, 2005
April 1998
 
 
 
Complete list of historical versions of study NCT00004446 on ClinicalTrials.gov Archive Site
 
 
 
Study of Fluoxetine in Patients With Depersonalization Disorder
 

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.

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.

 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control
Depersonalization Disorder
Drug: fluoxetine
 
Simeon D, Guralnik O, Schmeidler J, Knutelska M. Fluoxetine therapy in depersonalisation disorder: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:31-6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
80
 
 

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004446
 
199/13456, MTS-GCO-95-323
National Institute of Mental Health (NIMH)
Mount Sinai School of Medicine
Study Chair: Daphne Simeon Mount Sinai School of Medicine
National Institute of Mental Health (NIMH)
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP