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: September 30, 2013
Last verified: September 2013

November 28, 2011
September 30, 2013
December 2011
August 2013   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01482221 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Change in severity of depressive symptoms at each scheduled assessment as measured by the Clinical Global Impression-Improvement (CGI-I) response. Response 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Adverse events (AEs)/serious adverse events (SAEs), including their severity. [ Time Frame: Will be collected throughout the study period, Weeks 1 through 20. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • Percentage of patients with sustained response, defined as ≥50% reduction from baseline in the Montgomery-Åsberg 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Percentage of patients who are remitted at each scheduled assessment where remission is defined as Montgomery-Åsberg 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Adverse events (AEs)/serious adverse events (SAEs), including their severity. [ Time Frame: Will be collected throughout the study period, Weeks 1 through 20. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
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

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 NMDA class of glutamate receptors.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • 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
  • Experimental: 1
    Intervention: Drug: AZD6765 iv
  • Experimental: 2
    Intervention: Drug: AZD6765 iv
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Chile,   Slovakia,   South Africa
 
NCT01482221
D6702C00031, EudraCT number 2011-004690-87
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Dhaval A Desai, MD 1800 Concord Pike, Wilmington, DE 19850
AstraZeneca
September 2013

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