6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01145755
First received: May 27, 2010
Last updated: September 27, 2012
Last verified: September 2012

May 27, 2010
September 27, 2012
May 2010
November 2010   (final data collection date for primary outcome measure)
MADRS Total Score Change From Baseline to Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Change from baseline in MADRS total score to week 6 [ Time Frame: assessed on a once weekly basis for 6 weeks. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01145755 on ClinicalTrials.gov Archive Site
  • MADRS Response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.
  • MADRS Remission [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6
  • MADRS response defined as =50% reduction in MADRS total score from baseline to Week 6 [ Time Frame: assessed on a once weekly basis for 6 weeks. ] [ Designated as safety issue: No ]
  • MADRS remission defined by MADRS total score of =10 at Week 6 [ Time Frame: assessed on a once weekly basis for 6 weeks. ] [ Designated as safety issue: No ]
  • Change in the HAM-D total score from baseline to Week 6 [ Time Frame: assessed on a once weekly basis for 6 weeks. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

This 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: AZD2066
    18 mg once daily
  • Drug: Placebo
  • Drug: Duloxetine
    60 mg once daily
  • Experimental: AZD2066
    Intervention: Drug: AZD2066
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Duloxetine
    Duloxetine
    Intervention: Drug: Duloxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
131
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01145755
D0475C00020
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Richard Malamut AstraZeneca
Principal Investigator: Lora McGill CNS Healthcare
AstraZeneca
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP