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A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01482221
Recruitment Status : Completed
First Posted : November 30, 2011
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 28, 2011
First Posted Date  ICMJE November 30, 2011
Results First Submitted Date  ICMJE October 13, 2014
Results First Posted Date  ICMJE April 11, 2017
Last Update Posted Date April 11, 2017
Actual Study Start Date  ICMJE December 16, 2011
Actual Primary Completion Date August 26, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Week 6 ]
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
Change from baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5 and 6. ]
Change History Complete list of historical versions of study NCT01482221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Week 12 ]
    A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
  • Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12) [ Time Frame: Week 6 to Week 12 ]
    The percentage of patients with with Sustained Response (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12) was calculated.
  • Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6 [ Time Frame: Baseline to Week 6 ]
    The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
  • Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12 [ Time Frame: Baseline to Week 12 ]
    The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
  • Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6 [ Time Frame: Baseline to Week 6 ]
    The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
  • Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12 [ Time Frame: Baseline to Week 12 ]
    The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
  • Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to Week 12 ]
    A 3-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 intercorrelated domains (school/work, social life, and family life/home responsibilities), ranges from 0 (no impairment) to 30 (most severe impairment).
  • Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Baseline to Week 12 ]
    Clinical Global Impression - Severity (CGI-S) scale rates the severity of the patient's illness at the time of assessment, range from 1 (normal, not ill) to 7 (very severely ill).
  • Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 6 [ Time Frame: Baseline to Week 6 ]
    A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.
  • Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 12 [ Time Frame: Baseline to Week 12 ]
    A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.
  • Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score [ Time Frame: Baseline to Week 12 ]
    A 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
  • Change from baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10 and 12. ]
  • Percentage of patients with sustained response, defined as ≥50% reduction from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6 and which is maintained through Week 12 [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10 and 12. ]
  • Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at each scheduled assessment. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 16, 18 and 20. ]
  • Percentage of responders at each scheduled assessment where responders are defined as patients with a ≥50% reduction from baseline in Montgomery-Asberg Rating Scale (MADRS) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 16, 18 and 20. ]
  • Percentage of patients who are remitted at each scheduled assessment where remission is defined as Montgomery-Asberg Rating Scale (MADRS) total score ≤8. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 16, 18 and 20. ]
  • Change from baseline in functional impairment at each scheduled assessment, as measured by the change from baseline in the Sheehan Disability Scale (SDS) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 6, 12 and 20. ]
  • Change in severity of depressive symptoms at each scheduled assessment as measured by change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 16 and 20. ]
  • Change in severity of depressive symptoms at each scheduled assessment as measured by the Clinical Global Impression-Improvement (CGI-I) response. Respons in CGI-I is based on whether or not the CGI-I score is ≤2 (very much improved or much improved). [ Time Frame: Will be scored at Weeks 2, 3, 4, 5, 6, 8, 10, 12, 13, 16 and 20. ]
  • Change from baseline in self-rated severity of depressive symptoms at each scheduled assessment as measured by Quick Inventory of Depressive Symptomatology Self-Report 16-item scale (QIDS-SR-16) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 3, 6, 12, 16 and 20. ]
  • Adverse events (AEs)/serious adverse events (SAEs), including their severity. [ Time Frame: Will be collected throughout the study period, Weeks 1 through 20. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients With Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants
Brief Summary The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.
Detailed Description A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants
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: AZD6765 iv
    50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.
  • Drug: AZD6765 iv
    100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.
  • Drug: Placebo
    0.9 sodium chloride [normal saline] solution for injection by iv infusion
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: AZD6765 iv
  • Experimental: 2
    Intervention: Drug: AZD6765 iv
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
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: April 10, 2017)
542
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2011)
282
Actual Study Completion Date  ICMJE August 26, 2013
Actual Primary Completion Date August 26, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of signed and dated informed consent before initiation of any study-related procedures.
  • Male or female patients aged 18 to 70 years, inclusive.
  • The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants.
  • Women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start.
  • Outpatient status at screening and randomization visits.

Exclusion Criteria:

  • Patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
  • Patients who have had a suicide attempt within the last 6 months.
  • Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation.
  • Patients with any history of seizure disorder (except for febrile seizures in childhood).
  • Pregnancy or lactation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 Chile,   Slovakia,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01482221
Other Study ID Numbers  ICMJE D6702C00031
EudraCT number 2011-004690-87
Has Data Monitoring Committee Not Provided
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
Study Director: Dhaval A Desai, MD 1800 Concord Pike, Wilmington, DE 19850
PRS Account AstraZeneca
Verification Date April 2017

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