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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00789854

NCT00789854
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been officially diagnosed with Major Depressive Disorder (MDD) — either a single episode or a recurring episode — confirmed using a standard diagnostic interview tool
  • Your current episode of depression started at least 42 days before joining the trial, but no more than 18 months ago
  • Your depression symptoms score at least 25 points on a standard rating scale called the MADRS, both when you first enrol and when you are officially assigned to a treatment group

Who may not be able to join:

  • You have been diagnosed with another major mental health condition (other than MDD) within the 6 months before joining the trial (confirm with trial site)
  • You have a diagnosed personality disorder or similar condition that is significantly affecting your current mental health status (confirm with trial site)
  • In the doctor's judgement, you are currently at serious risk of harming yourself or others, or you have attempted suicide in the past 6 months

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
AstraZeneca
Registry
clinicaltrials_gov
Start date
1 November 2008
Est. completion
1 August 2009

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇩🇰 Denmark 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇵🇹 Portugal 🇷🇴 Romania 🇸🇰 Slovakia 🇪🇸 Spain 🇬🇧 United Kingdom

11 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set); Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov