Clinical trial NCT01020799: AZD7268 Safety and Tolerability Study
Official title: A Phase II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Depression
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-26
Enrollment: 247
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: The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written, and dated Informed Consent prior to any study specific procedures
* Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
* 296.2x Major Depressive Disorder, Single Episode, or
* 296.3x Major Depressive Disorder, Recurrent

Exclusion Criteria:

* Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
* Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
* Patients whose current episode of depression started less than 4 weeks before enrollment

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) Response
timeFrame: Week 4
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) Remission
timeFrame: Week 4
measure: Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.
timeFrame: Baseline, Week 4
measure: Clinical Global Impression - Severity (CGI-S) Score Change From Baseline
timeFrame: Baseline, Week 4
measure: Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Garden Grove
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Bradenton
country: United States
facility: Research Site
state: Florida
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: Cedarhurst
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Dayton
country: United States
facility: Research Site
state: Ohio
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:
References: