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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Lithium Carbonate; Quetiapine Fumarate; Serotonin Uptake Inhibitors; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode

• Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months

• MADRS-Score ≥ 25 at enrolment and randomisation

Exclusion Criteria:

• Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation

• Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status

• Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months