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Study of Fluoxetine in Patients With Depersonalization Disorder

Primary Purpose

Depersonalization Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluoxetine
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depersonalization Disorder focused on measuring depersonalization disorder, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Medical Center, NY

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Mental Health (NIMH)
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT00004446
Brief Title
Study of Fluoxetine in Patients With Depersonalization Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Mental Health (NIMH)
Collaborators
Icahn School of Medicine at Mount Sinai

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depersonalization Disorder
Keywords
depersonalization disorder, neurologic and psychiatric disorders, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluoxetine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne Simeon
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15231553
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.
Results Reference
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Study of Fluoxetine in Patients With Depersonalization Disorder

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