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

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 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 Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Antidepressants Depression

U.S. FDA Resources

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: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5 and 6. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	282
Study Start Date:	December 2011
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	October 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
Genders Eligible for Study:	Both
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

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

Contacts

Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com
Contact: Quintiles		clinical.studies.ns@quintiles.com

Show 54 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Dhaval A Desai, MD

1800 Concord Pike, Wilmington, DE 19850

More Information

No publications provided

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
Last Updated:	April 18, 2013
Health Authority:	United States: Food and Drug Administration Czech Republic: State Institute for Drug Control Slovakia: State Institute for Drug Control South Africa: Medicines Control Council Chile: Instituto de Salud Publica de Chile

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:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013