EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

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.

Research Site

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

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.

Age Continuous

Gender, Male/Female

MADRS total score change from baseline to Week 6

A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.

MADRS response

A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6

MADRS remission

Overall Study

Patients with major depressive disorder were included.

Arms	Assigned Interventions
Experimental: AZD2066	Drug: AZD2066 18 mg once daily
Placebo Comparator: Placebo	-
Active Comparator: Duloxetine Duloxetine	Drug: Duloxetine 60 mg once daily

6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=230&filename=CSR-D0475C00020.pdf

CSR-D0475C00020.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator