Prozac Treatment of Major Depression: Discontinuation Study

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

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 double-blind trial to determine if stratification category predicted continuation outcome.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Massachusetts General Hospital
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

1. men and women ages 18-65

2. meets criteria for DSM IV Major Depression

3. signs informed consent and able to comply with study

Exclusion Criteria:

1. pregnant women and women of child-bearing potential who are not using a medically accepted means of contraception.

2. women taking oral contraceptives, the initiation of which was temporally associated with the onset of depression; women who are breast-feeding.

3. Patients with serious suicidal risk, including any patient who became suicidal with previous discontinuation of an antidepressant.

4. Patients with a history of seizure disorder.

5. Patients with unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic) or any physical disorder judged to significantly affect CNS function.

6. 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

7. 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.

8. Concurrent use of exclusionary drugs

9. Clinical or laboratory evidence of hypothyroidism without adequate stable replacement (eg, low total T4 or elevated TSH by a high sensitivity method).