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Home > "S" Clinical Trials Conditions > Study of Fluoxetine in Patients with Depersonalization Disorder  Study of Fluoxetine in Patients with Depersonalization Disorder
Study of Fluoxetine in Patients with Depersonalization Disorder
For Condition: Depersonalization Disorder
Status: No longer recruiting
Sponsor(s): National Institute of Mental Health (NIMH) , Mount Sinai Medical Center
Synopsis: OBJECTIVES: I. Determine the effects of fluoxetine in the treatment of depersonalization disorder. II. Assess the durability of treatment response in these patients. III. Assess the improvement in psychiatric disability in these patients. IV. 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.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to receive either fluoxetine or placebo. Treatment consists of two phases (acute treatment and maintenance). Acute treatment phase: Patients receive fluoxetine or placebo daily for 12 weeks. Patients are followed every 2 weeks. Maintenance phase: Patients showing significant improvement after 12 weeks may continue treatment for an additional 6 months. Patients are followed every 4 weeks. Patients who do not improve during the acute treatment phase may receive open fluoxetine, or another appropriate medication, for 3 months.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Meets DSM-IV criteria for depersonalization disorder in the last month --Prior/Concurrent Therapy-- Biologic therapy: No concurrent biologic therapy Chemotherapy: No concurrent chemotherapy Other: At least 2 weeks since antipsychotics, anticonvulsants, stimulants, barbiturates, lithium, or benzodiazepines; At least 2 weeks since antidepressants; At least 4 weeks since MAO inhibitors; At least 4 weeks since investigational drugs; No history of prior fluoxetine at a dose of 10 mg or more for at least 6 weeks duration; No concurrent psychotropic medications --Patient Characteristics-- Hematopoietic: No hematologic disease Hepatic: No hepatic disease Renal: No renal disease Cardiovascular: No cardiovascular disease Pulmonary: No pulmonary disease Other: No gastrointestinal disease; No prior or concurrent mental disorders such as the following: Schizophrenia, Schizoaffective disorder, Organic mental disorder, Bipolar disorder; No current substance abuse; No current eating disorder; No current clinically unstable suicidal ideation; No unstable medical illness; Must be clinically stable; No metabolic disease; No endocrine disease; No other systemic disease; No clinically important abnormalities in lab tests or physical exams; No history of seizure disorders or abnormal electroencephalogram; No hypersensitivity or severe side effects to fluoxetine; Not pregnant or lactating; Fertile women must use effective contraception
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
DaphneSimeon, Study Chair, Mount Sinai Medical Center
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Additional Information:
Study ID Numbers: 199/13456; MTS-GCO-95-323
Study Start Date: April 1998
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004446
Other Depersonalization Disorder Studies:
1. Study of Fluoxetine in Patients with Depersonalization Disorder
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Study of Fluoxetine in Patients with Depersonalization Disorder
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