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

NCT01482221 | Completed Phase 2 Results

• 2 other identifiers: D6702C00031EudraCT number 2011-004690-87
• Study Type: interventional
• Target: 542
• Locations: 4 countries
• Sites: 44

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; Inadequate Response to Antidepressant Therapy; Channel blocker of the NMDA class of glutamate receptors

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  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.

  Baseline to Week 6

Secondary Outcomes (11)

• Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  Baseline to Week 12

• 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)

  Week 6 to Week 12

• Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6

  Baseline to Week 6

• Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12

  Baseline to Week 12

• Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6

  Baseline to Week 6

Study Arms (3)

1

EXPERIMENTAL

Drug: AZD6765 iv

2

EXPERIMENTAL

Drug: AZD6765 iv

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD6765 iv DRUG

50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.

1

Placebo DRUG

0.9 sodium chloride \[normal saline\] solution for injection by iv infusion

3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (44)

Research Site

Chino, California, United States

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Lond Beach, California, United States

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San Diego, California, United States

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Stanford, California, United States

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New Heaven, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Gainsville, Florida, United States

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Lake City, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Hoffman Estates, Illinois, United States

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Joliet, Illinois, United States

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Skokie, Illinois, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Willingboro, New Jersey, United States

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Mount Kisco, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Bellevue, Washington, United States

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Antofagasta, Chile

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Santiago, Chile

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Bratislava, Slovakia

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Liptovský Mikuláš, Slovakia

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Michalovce Stranany, Slovakia

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Rimavská Sobota, Slovakia

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Svidník, Slovakia

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Trnava, Slovakia

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Cape Town, South Africa

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Johannesburg, South Africa

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Tygervalley, South Africa

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Related Links

• D6702C00031\_Clinical Study Report\_Synopsis

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Sanjeev Pathak
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Dhaval A Desai, MD

  1800 Concord Pike, Wilmington, DE 19850

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: November 30, 2011
• Study Start: December 16, 2011
• Primary Completion: August 26, 2013
• Study Completion: August 26, 2013
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-04

Locations

CL (2); ZA (3); US (33); SL (6)