Study of Fluoxetine in Patients With Depersonalization Disorder
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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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | April 1998 |
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 |
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| United States, New York | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| 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 May 19, 2013