Study of Fluoxetine in Patients With Depersonalization Disorder

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai School of Medicine
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
  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:


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
Mount Sinai School of Medicine
Investigators
Study Chair: Daphne Simeon Mount Sinai School of Medicine
  More Information

Publications:
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
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Depersonalization
Behavioral Symptoms
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014