Study of Fluoxetine in Patients With Depersonalization Disorder

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Institute of Mental Health (NIMH) Mount Sinai School of Medicine
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00004446

Purpose

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.

Condition	Intervention
Depersonalization Disorder	Drug: fluoxetine

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	80
Study Start Date:	April 1998

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004446

Locations

United States, New York
Mount Sinai Medical Center, NY
New York, New York, United States, 10029

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Mount Sinai School of Medicine

Investigators

Study Chair:

Daphne Simeon

Mount Sinai School of Medicine

More Information

Publications:

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

Study ID Numbers:	199/13456, MTS-GCO-95-323
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004446 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

depersonalization disorder
neurologic and psychiatric disorders
rare disease

Study placed in the following topic categories:

Fluoxetine
Depersonalization Disorder
Neurotransmitter Agents
Depersonalization
Mental Disorders
Psychotropic Drugs

Rare Diseases
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Antidepressive Agents
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Depersonalization
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions

Behavioral Symptoms
Fluoxetine
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009