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COMPLETED Phase 4

Prozac Treatment of Major Depression: Discontinuation Study

NCT00427128 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00427128

The ClinicalTrials.gov registry entry for NCT00427128 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 627 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00427128 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00427128?

The interventions under investigation include: placebo (DRUG), fluoxetine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00427128?

This trial is sponsored by New York State Psychiatric Institute, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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