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NCT00388973 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
338
Enrollment target

NCT00388973: Completed Phase 3 study, sponsored by AstraZeneca.

NCT00388973 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 338 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00388973, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
338 participants
Enrollment target

Study Summary

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with major depressive disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Primary Outcome

MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.

Interventions

  • DRUG Quetiapine

Trial Details

FieldValue
Enrollment Target 338 participants
Start Date 2006-09
Est. Completion 2007-12
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00388973 record still lists

NCT00388973 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 1 intervention - of which Quetiapine is the first listed.

NCT00388973 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00388973 about?

NCT00388973 is a clinical study titled "Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder". The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with major depressive disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the...

What is the current status of trial NCT00388973?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 338 participants. The study started on 2006-09. Estimated completion is 2007-12.

What interventions are being tested in trial NCT00388973?

The interventions under investigation include: Quetiapine (DRUG).

Who is sponsoring clinical trial NCT00388973?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00388973's enrollment target sits among peer trials

338 1057th of 2000 higher than 942 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00388973, the US trial registry maintained by the National Library of Medicine. NCT00388973 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.