AZD7268 Safety and Tolerability Study

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020799
• Other study ID #: D1151C00005
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2009
• Last updated: April 11, 2012
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• AZD7268
15 mg, oral, twice daily (BID)
• Escitalopram
20 mg, oral, once daily (QD)
• Placebo capsules
Placebo capsules to match AZD7268
• Placebo tablets
Placebo tablets to match encapsulated escitalopram

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bellevue	Washington
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bradenton	Florida
United States	Research Site	Cedarhurst	New York
United States	Research Site	Dayton	Ohio
United States	Research Site	Friendswood	Texas
United States	Research Site	Garden Grove	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Portland	Oregon
United States	Research Site	Rochester	New York
United States	Research Site	Rockville	Maryland
United States	Research Site	San Diego	California
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.	MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]	Baseline, Week 4	No
Secondary	Montgomery-Åsberg Depression Rating Scale (MADRS) Response	Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]	Week 4	No
Secondary	Montgomery-Åsberg Depression Rating Scale (MADRS) Remission	Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]	Week 4	No
Secondary	Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.	HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]	Baseline, Week 4	No
Secondary	Clinical Global Impression - Severity (CGI-S) Score Change From Baseline	CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 ("Normal, not ill") to 7 ("Among the most extremely ill patients"). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]	Baseline, Week 4	No
Secondary	Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline	HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]	Baseline, Week 4	No