Status:
COMPLETED
Prozac Treatment of Major Depression: Discontinuation Study
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Major Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study randomized two stratifications of acute phase MDD SSRI responders, categorized as having either "true drug" response or "placebo response" pattern, to continuation with SSRI vs placebo in a...
Detailed Description
This study enrolled 627 subjects with Major Depressive illness at New York State Psychiatric Institute and Massachusetts General Hospital. Subjects were treated with fluoxetine 10-60mg over a 12 week ...
Eligibility Criteria
Inclusion
- men and women ages 18-65
- meets criteria for DSM IV Major Depression
- signs informed consent and able to comply with study
Exclusion
- pregnant women and women of child-bearing potential who are not using a medically accepted means of contraception.
- women taking oral contraceptives, the initiation of which was temporally associated with the onset of depression; women who are breast-feeding.
- Patients with serious suicidal risk, including any patient who became suicidal with previous discontinuation of an antidepressant.
- Patients with a history of seizure disorder.
- Patients with unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic) or any physical disorder judged to significantly affect CNS function.
- Patients meeting criteria for the following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; antisocial personality disorder; or presence of psychotic features
- Patients with a history of non-response to an adequate trial of a selective serotonin reuptake inhibitor in a past or current depressive episode, defined as a four-week trial of a minimum of 40mg/day of fluoxetine or paroxetine, or 100mg/day of sertraline.
- Concurrent use of exclusionary drugs
- Clinical or laboratory evidence of hypothyroidism without adequate stable replacement (eg, low total T4 or elevated TSH by a high sensitivity method).
Key Trial Info
Start Date :
November 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT00427128
Start Date
November 1 1995
End Date
March 1 2003
Last Update
December 15 2011
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
New York State Psychiatric Institute
New York, New York, United States, 10032