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Prozac Treatment of Major Depression: Discontinuation Study

NCT00427128 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 627

Last updated 2011-12-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

fluoxetine

10mg/day increased over 12 weeks to 20-80 mg/day; 20-80 mg/day maintained from week 13-36.

DRUG

placebo

Week 13-36.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Patrick J McGrath, MD · New York State Psychiatric Institute

  • Maurizio Fava, MD · Massachussets General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-11-30
Completion
2003-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00427128 on ClinicalTrials.gov