Trial record 4 of 5 for: "Depersonalization"

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Study of Fluoxetine in Patients With Depersonalization Disorder

This study has been completed.

Sponsor:

Collaborator:

Icahn School of Medicine at Mount Sinai

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00004446

First received: October 18, 1999

Last updated: June 23, 2005

Last verified: March 2005

History of Changes

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

Genetic and Rare Diseases Information Center resources: Depersonalization Disorder

U.S. FDA Resources

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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)

Icahn School of Medicine at Mount Sinai

Investigators


Study Chair:	Daphne Simeon	Icahn School of Medicine at Mount Sinai

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.


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

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


depersonalization disorder neurologic and psychiatric disorders rare disease

Additional relevant MeSH terms:


Depersonalization Disease Pathologic Processes Behavioral Symptoms Fluoxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action	Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 13, 2017

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