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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2011-004690-87 |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6765 iv | Drug | 50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhaval A Desai, MD | 1800 Concord Pike, Wilmington, DE 19850 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chino | California | United States | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| D6702C00031\_Clinical Study Report\_Synopsis | View source |
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The study had a screening/washout period of up to 42 days, a 12-week double blind treatment period, and a 14-day follow-up period. Patients received 3 infusions per week during Weeks 1 to 3,1 infusion per week during Weeks 4 to 6, and 1 infusion every other week during Weeks 7 to 12.
This multicenter study was conducted in Chile, Slovakia, South Africa, and the United States between 16 December 2011 and 26 August 2013. A total of 542 patients were enrolled in the study and of these, 302 patients were randomized to treatment. 240 patients were not randomized to treatment due to eligibility criteria not being fulfilled.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD6765 50 mg | Intravenous infusion |
| FG001 | AZD6765 100 mg | Intravenous infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AZD6765 iv |
| Drug |
100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion. |
|
| Placebo | Drug | 0.9 sodium chloride [normal saline] solution for injection by iv infusion |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Lond Beach |
| California |
| United States |
| Research Site | San Diego | California | United States |
| Research Site | Stanford | California | United States |
| Research Site | New Heaven | Connecticut | United States |
| Research Site | Fort Lauderdale | Florida | United States |
| Research Site | Gainsville | Florida | United States |
| Research Site | Lake City | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | St. Petersburg | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Decatur | Georgia | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | Joliet | Illinois | United States |
| Research Site | Skokie | Illinois | United States |
| Research Site | Lake Charles | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Willingboro | New Jersey | United States |
| Research Site | Mount Kisco | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Antofagasta | Chile |
| Research Site | Santiago | Chile |
| Research Site | Bratislava | Slovakia |
| Research Site | Liptovský Mikuláš | Slovakia |
| Research Site | Michalovce Stranany | Slovakia |
| Research Site | Rimavská Sobota | Slovakia |
| Research Site | Svidník | Slovakia |
| Research Site | Trnava | Slovakia |
| Research Site | Cape Town | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Tygervalley | South Africa |
| FG002 |
| Placebo |
Intravenous infusion |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD6765 50 mg | Intravenous infusion |
| BG001 | AZD6765 100 mg | Intravenous infusion |
| BG002 | Placebo | Intravenous infusion |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The modified intent-to-treat (mITT) analysis set included all randomized patients, who took investigational product (IP) and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| 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. | The modified intent-to-treat (mITT) analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 12 |
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| 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. | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Number | percentage of participants analyzed | Week 6 to Week 12 |
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| 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. | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Number | percentage of participants analyzed | Baseline to Week 6 |
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| 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. | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Number | percentage of participants analyzed | Baseline to Week 12 |
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| 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. | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Number | percentage of participants analyzed | Baseline to Week 6 |
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| 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. | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Number | percentage of participants analyzed | Baseline to Week 12 |
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| 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). | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 12 |
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| 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). | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 12 |
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| 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. | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Number | percentage of participants analyzed | Baseline to Week 6 |
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| 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. | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Number | percentage of participants analyzed | Baseline to Week 12 |
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| 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). | The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 12 |
|
Not provided
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD6765iv 100 mg | Intravenous infusion | 4 | 100 | 68 | 100 | ||
| EG001 | AZD6765iv 50 mg | Intravenous infusion | 2 | 101 | 59 | 101 | ||
| EG002 | Placebo | Intravenous infusion | 4 | 100 | 47 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 16.0 | Systematic Assessment |
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| HEPATITIS C | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| DEPRESSIVE SYMPTOM | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| INTENTIONAL DRUG MISUSE | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 16.0 | Systematic Assessment |
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| FEELING DRUNK | General disorders | MedDRA 16.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| SEDATION | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| DISSOCIATION | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjeev Pathak | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Black or African American |
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| Asian |
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| Other |
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| Superiority or Other |
| MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect. | Mixed models for repeated measures | 0.476 | The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response). | LS mean difference | -1.21 | Standard Error of the Mean | 1.701 | 2-Sided | 95 | -4.563 | 2.134 | Superiority or Other |
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