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

NCT00789854 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2012-05-23

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Michael Bauer, professor · Germany

  • Birgit Ekholm, PhD · AstraZeneca MC Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Denmark
  • Germany
  • Hungary
  • Italy
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00789854 on ClinicalTrials.gov