Depression With Prominent Agitation Clinical Trial
Official title:
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Escitalopram Controlled Phase III-B Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR TM) as Monotherapy in the Treatment of Adult Patients With Agitated Major Depressive Disorder
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment