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NCT00427128 · ClinicalTrials.gov registry record · Phase 4

Prozac Treatment of Major Depression: Discontinuation Study

A Phase 4 study of Major Depression, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 4
Development phase
627
Enrollment target
2
Study locations

NCT00427128 is a Phase 4 study of Major Depression that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 627 participants, above the 305-participant average among 28 other Major Depression trials with a reported enrollment target (106% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT00427128, a Phase 4 study of Major Depression, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 4
Development phase
627 participants
Enrollment target
2
Study locations

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 Studied

Interventions

  • DRUG placebo
  • DRUG fluoxetine

Study Locations (2)

Massachusetts

  • Massachusetts General Hospital - Boston

New York

  • New York State Psychiatric Institute - New York

Trial Details

FieldValue
Enrollment Target 627 participants
Start Date 1995-11
Est. Completion 2003-03
Phase Phase 4

What the Registry Record Tells You About NCT00427128

The ClinicalTrials.gov registry entry for NCT00427128 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 627 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 305-participant average among 28 other Major Depression trials with a reported enrollment target (106% higher). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depression appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00427128 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT00427128 about?

NCT00427128 is a clinical study titled "Prozac Treatment of Major Depression: Discontinuation Study". 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.

What is the current status of trial NCT00427128?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 627 participants. The study started on 1995-11. Estimated completion is 2003-03.

What conditions does trial NCT00427128 study?

This clinical trial studies the following conditions: Major Depression.

What interventions are being tested in trial NCT00427128?

The interventions under investigation include: placebo (DRUG), fluoxetine (DRUG).

Who is sponsoring clinical trial NCT00427128?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00427128 being conducted?

This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.