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NCT00057577 · ClinicalTrials.gov registry record · Phase 4

Prevention of Recurrence in Depression With Drugs and CT

A Phase 4 study, sponsored by Vanderbilt University.

Completed
Registry status
Phase 4
Development phase
452
Enrollment target

NCT00057577: Completed Phase 4 study, sponsored by Vanderbilt University.

NCT00057577 is a Phase 4 study that has completed, run by Vanderbilt University. The registered enrollment target is 452 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00057577, a Phase 4 study, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
Phase 4
Development phase
452 participants
Enrollment target

Study Summary

This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

Primary Outcome

Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)

Interventions

  • BEHAVIORAL Cognitive Therapy
  • DRUG Medications

Trial Details

FieldValue
Enrollment Target 452 participants
Start Date 2002-10
Est. Completion 2014-03
Phase Phase 4
Vanderbilt University

430 total trials

What the finished NCT00057577 record still lists

NCT00057577 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower).

The record links to 0 conditions, and to 2 interventions - of which Cognitive Therapy is the first listed.

NCT00057577 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00057577 about?

NCT00057577 is a clinical study titled "Prevention of Recurrence in Depression With Drugs and CT". This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

What is the current status of trial NCT00057577?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 452 participants. The study started on 2002-10. Estimated completion is 2014-03.

What interventions are being tested in trial NCT00057577?

The interventions under investigation include: Cognitive Therapy (BEHAVIORAL), Medications (DRUG).

Who is sponsoring clinical trial NCT00057577?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00057577's enrollment target sits among peer trials

452 187th of 2000 higher than 1,814 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00057577, the US trial registry maintained by the National Library of Medicine. NCT00057577 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.