Completed

Fluoxetine or Placebo Treatment for Depersonalization Disorder

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

fluoxetine

Drug
Who is being recruted

Behavior+8

+ Behavioral Symptoms

+ Nervous System Diseases

From 18 to 65 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 1998
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00004446
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsNervous System DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesMental DisordersDepersonalizationNeurologic ManifestationsRare Diseases

Criteria

15 exclusion criteria prevent from participating
Clinically important abnormalities in lab tests or physical exams

Clinically unstable

Current clinically unstable suicidal ideation

Current eating disorder

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mount Sinai Medical Center, NY

New York, United StatesOpen Mount Sinai Medical Center, NY in Google Maps
CompletedOne Study Center