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Study of Fluoxetine in Patients With Depersonalization Disorder

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ClinicalTrials.gov Identifier: NCT00004446
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by:
National Institute of Mental Health (NIMH)

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.


Condition or disease Intervention/treatment
Depersonalization Disorder Drug: fluoxetine

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : April 1998

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine
U.S. FDA Resources





Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00004446     History of Changes
Other Study ID Numbers: 199/13456
MTS-GCO-95-323
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2005

Keywords provided by National Institute of Mental Health (NIMH):
depersonalization disorder
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Disease
Depersonalization
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