Prozac Treatment of Major Depression: Discontinuation Study
Completed · Phase 4 · Has a placebo group
Conditions studied: Major Depression
In brief
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 double-blind trial to determine if stratification category predicted continuation outcome.
Key facts
- Study ID
- NCT00427128
- Run by
- New York State Psychiatric Institute
- People needed
- 627
- Starts
- 1995-11-01
- Expected to finish
- 2003-03-01
- Last updated by the study team
- 2011-12-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- men and women ages 18-65
- meets criteria for DSM IV Major Depression
- signs informed consent and able to comply with study
You may not qualify if…
- 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).
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- New York State Psychiatric Institute — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.