drugset / Trial / NCT01363310

The Quietude Study: Quetiapine Use for Agitated Depression

NCT01363310

Phase 3 Terminated 250 enrolled Physicians Research And Education Network
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Most individuals with major depressive disorder manifest clinically significant agitation. Concurrent agitation in a depressed individual is associated with an intensification of mood symptoms, decreased probability of recovery, increased recurrence risk, suicidality, and increased medical-service utilization. The occurrence of anxiety/agitation phenomenology in the depressed patient often invites the need for augmentation strategies (e.g. atypical antipsychotics, benzodiazepines, etc.) and complicated polypharmacy regimens. Moreover, individuals with major depressive disorder often report worsening of symptom severity, irritability, hostility, dysphoria, and significant subjective distress (This response pattern is similar to individuals with bipolar disorder). Results from large research studies provide evidence indicating that quetiapine is capable of offering clinically significant multidimensional symptom relief in bipolar depression. Moreover, results from several trials in major depressive disorder and generalized anxiety disorder have established the efficacy of quetiapine therapy for unipolar depression and anxiety syndromes. So far, no atypical antipsychotic agent has been evaluated specifically for the treatment of agitated depression. In this study, it is hypothesized that persons with major depressive disorder and prominent agitation (i.e. agitated depression) will exhibit a more favourable response and tolerability profile to quetiapine XR when compared to escitalopram.

Timeline

Start
2010-10
Primary completion
2013-01
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Escitalopram Small molecule 10 mg
Comparator Escitalopram Small molecule 20 mg
Comparator Quetiapine Small molecule 150 mg
Comparator Quetiapine Small molecule 300 mg