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AZD7268 Safety and Tolerability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01020799
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : April 10, 2012
Last Update Posted : April 17, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 25, 2009
First Posted Date  ICMJE November 26, 2009
Results First Submitted Date  ICMJE January 11, 2012
Results First Posted Date  ICMJE April 10, 2012
Last Update Posted Date April 17, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4. [ Time Frame: Baseline, 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)]
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
Change in the MADRS total score from baseline to Week 4 [ Time Frame: 1 per visit (6 visits) ]
Change History Complete list of historical versions of study NCT01020799 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • Montgomery-Åsberg Depression Rating Scale (MADRS) Response [ Time Frame: Week 4 ]
    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)]
  • Montgomery-Åsberg Depression Rating Scale (MADRS) Remission [ Time Frame: Week 4 ]
    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)]
  • Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4. [ Time Frame: Baseline, 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)]
  • Clinical Global Impression - Severity (CGI-S) Score Change From Baseline [ Time Frame: Baseline, Week 4 ]
    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)]
  • Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline [ Time Frame: Baseline, Week 4 ]
    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)]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
  • MADRS response defined as ≥50% reduction in MADRS total score from baseline to Week 4 [ Time Frame: 1 per visit (6 visits) ]
  • Change in the HAM-D total score from baseline to Week 4 [ Time Frame: 1 per visit (6 visits) ]
  • Change in the HAM-A total score from baseline to Week 4 [ Time Frame: 1 per visit (6 visits) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AZD7268 Safety and Tolerability Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: AZD7268
    15 mg, oral, twice daily (BID)
  • Drug: Escitalopram
    20 mg, oral, once daily (QD)
  • Drug: Placebo capsules
    Placebo capsules to match AZD7268
  • Drug: Placebo tablets
    Placebo tablets to match encapsulated escitalopram
Study Arms  ICMJE
  • Experimental: AZD7268
    The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only.
    Interventions:
    • Drug: AZD7268
    • Drug: Placebo tablets
  • Placebo Comparator: Placebo
    The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only.
    Interventions:
    • Drug: Placebo capsules
    • Drug: Placebo tablets
  • Active Comparator: Escitalopram
    The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.
    Interventions:
    • Drug: Escitalopram
    • Drug: Placebo capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2012)
247
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2009)
240
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01020799
Other Study ID Numbers  ICMJE D1151C00005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date April 2012

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