NCT00004446

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2005

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Depersonalization Disorder

Keywords

depersonalization disorderneurologic and psychiatric disordersrare disease

Interventions

fluoxetineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

Related 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. doi: 10.1192/bjp.185.1.31.

    PMID: 15231553BACKGROUND

MeSH Terms

Conditions

DepersonalizationNeurologic ManifestationsMental DisordersRare Diseases

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Daphne Simeon

    Icahn School of Medicine at Mount Sinai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

April 1, 1998

Last Updated

June 24, 2005

Record last verified: 2005-03

Locations

US(1)