Title
6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020
Phase
Phase 2Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Major Depressive DisorderIntervention/Treatment
azd-2066 duloxetine ...Study Participants
131This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.
18 mg once daily
60 mg once daily
Inclusion Criteria: Provision of signed, written, and dated Informed Consent Documented primary clinical diagnosis of Major Depressive Disorder Exclusion Criteria: Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder Patients whose current episode of depression started less than 4 weeks before enrollment History of inadequate response of antidepressants during current depressive episode
| Event Type | Organ System | Event Term | AZD2066 | Duloxetine | Placebo |
|---|
Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.
A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.
A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6
