Clinical trial NCT01145755: 6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Depression
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-17
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: MADRS Total Score Change From Baseline to Week 6
timeFrame: 6 weeks
Secondary outcomes:
measure: MADRS Response
timeFrame: 6 weeks
measure: MADRS Remission
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Cedarhurst
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Friendswood
country: United States
facility: Research Site
state: Texas
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: AstraZeneca
name: Richard Malamut
role: STUDY_CHAIR
affiliation: CNS Healthcare
name: Lora McGill
role: PRINCIPAL_INVESTIGATOR
References: