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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01482221
First received: November 28, 2011
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder
Drug: AZD6765 iv
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 542
Actual Study Start Date: December 16, 2011
Study Completion Date: August 26, 2013
Primary Completion Date: August 26, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD6765 iv
50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.
Experimental: 2 Drug: AZD6765 iv
100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.
Placebo Comparator: 3 Drug: Placebo
0.9 sodium chloride [normal saline] solution for injection by iv infusion

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482221

  Show 44 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dhaval A Desai, MD 1800 Concord Pike, Wilmington, DE 19850
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01482221     History of Changes
Other Study ID Numbers: D6702C00031
EudraCT number 2011-004690-87
Study First Received: November 28, 2011
Results First Received: October 13, 2014
Last Updated: April 10, 2017

Keywords provided by AstraZeneca:
Major Depressive Disorder
MDD
Inadequate Response to Antidepressant Therapy
Channel blocker of the NMDA class of glutamate receptors

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 26, 2017