NCT00789854

Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients

A Randomised, 6-week, Multicentre, Open-label, Rater-blinded Parallel Group Study Comparing Quetiapine Extended Release Monotherapy and Augmentation With Lithium Augmentation in Patients With Treatment Resistant Depression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 688 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.

Detailed description

The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.

Conditions

• Major Depressive Disorder
• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	Quetiapine XR	300 mg once daily (od)
DRUG	Lithium carbonate	900 mg once daily (od)
DRUG	SSRI/Venlafaxine	SSRI - doses within label, Venlafaxine dose up to 225 mg/day

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-11-13
• Last updated: 2012-05-23
• Results posted: 2012-05-23

Locations

106 sites across 13 countries: Australia, Austria, Belgium, Bulgaria, Denmark, Germany, Hungary, Italy, Portugal, Romania, Slovakia, Spain, United Kingdom