Major Depressive Disorder Clinical Trial
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
Verified date | April 2017 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 542 |
Est. completion date | August 26, 2013 |
Est. primary completion date | August 26, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Chile | Research Site | Antofagasta | |
Chile | Research Site | Santiago | |
Slovakia | Research Site | Bratislava | |
Slovakia | Research Site | Liptovsky Mikulas | |
Slovakia | Research Site | Michalovce Stranany | |
Slovakia | Research Site | Rimavska Sobota | |
Slovakia | Research Site | Svidnik | |
Slovakia | Research Site | Trnava | |
South Africa | Research Site | Cape Town | |
South Africa | Research Site | Johannesburg | |
South Africa | Research Site | Tygervalley | |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Baltimore | Maryland |
United States | Research Site | Bellevue | Washington |
United States | Research Site | Boston | Massachusetts |
United States | Research Site | Chino | California |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Dallas | Texas |
United States | Research Site | Dayton | Ohio |
United States | Research Site | Decatur | Georgia |
United States | Research Site | Ft. Lauderdale | Florida |
United States | Research Site | Gainsville | Florida |
United States | Research Site | Hoffman Estates | Illinois |
United States | Research Site | Houston | Texas |
United States | Research Site | Joliet | Illinois |
United States | Research Site | Lake Charles | Louisiana |
United States | Research Site | Lake City | Florida |
United States | Research Site | Lond Beach | California |
United States | Research Site | Miami | Florida |
United States | Research Site | Minneapolis | Minnesota |
United States | Research Site | Mount Kisco | New York |
United States | Research Site | New Heaven | Connecticut |
United States | Research Site | New York | New York |
United States | Research Site | Orlando | Florida |
United States | Research Site | Philadelphia | Pennsylvania |
United States | Research Site | Rochester | New York |
United States | Research Site | San Diego | California |
United States | Research Site | Shreveport | Louisiana |
United States | Research Site | Skokie | Illinois |
United States | Research Site | St Petersburg | Florida |
United States | Research Site | St. Louis | Missouri |
United States | Research Site | Stanford | California |
United States | Research Site | Willingboro | New Jersey |
United States | Research Site | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Chile, Slovakia, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change From Baseline to Week 12 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 12 | |
Secondary | 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) | 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. | Week 6 to Week 12 | |
Secondary | Percentage of Patients Who Were Responders (Defined as a =50% Reduction From Baseline in MADRS Total Score) at Week 6 | The percentage of patients who were Responders (defined as =50% reduction from baseline in MADRS total score) was calculated. | Baseline to Week 6 | |
Secondary | Percentage of Patients Who Were Responders (Defined as a =50% Reduction From Baseline in MADRS Total Score) at Week 12 | The percentage of patients who were Responders (defined as =50% reduction from baseline in MADRS total score) was calculated. | Baseline to Week 12 | |
Secondary | Percentage of Patients Who Were Remitted (Defined as MADRS Total Score =10) at Week 6 | The percentage of patients who were Remitted (defined as MADRS total score =10) was calculated. | Baseline to Week 6 | |
Secondary | Percentage of Patients Who Were Remitted (Defined as MADRS Total Score =10) at Week 12 | The percentage of patients who were Remitted (defined as MADRS total score =10) was calculated. | Baseline to Week 12 | |
Secondary | Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | 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). | Baseline to Week 12 | |
Secondary | Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score | 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). | Baseline to Week 12 | |
Secondary | 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 | 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. | Baseline to Week 6 | |
Secondary | 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 | 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. | Baseline to Week 12 | |
Secondary | 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 | 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). | Baseline to Week 12 |
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