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This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD2066 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Duloxetine | Active Comparator | Duloxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2066 | Drug | 18 mg once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| MADRS Total Score Change From Baseline to Week 6 | Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MADRS Response | A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score. | 6 weeks |
| MADRS Remission | A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Malamut | AstraZeneca | Study Chair |
| Lora McGill | CNS Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Garden Grove | California | United States | |||
| Research Site |
Patients with major depressive disorder were included.
This study was conducted only in the United States (US). A total of 13 study centers enrolled 249 patients. First subject enrolled: 27 May 2010 Last subject last visit: 10 November 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD2066 | AZD2066 12 mg, 18 mg |
| FG001 | Duloxetine | Duloxetine 30 mg, 60 mg |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Duloxetine | Drug | 60 mg once daily |
|
| 6 weeks |
| San Diego |
| California |
| United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Rockville | Maryland | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Cedarhurst | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Friendswood | Texas | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Placebo |
Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2066 | AZD2066 12 mg, 18 mg |
| BG001 | Duloxetine | Duloxetine 30 mg, 60 mg |
| BG002 | Placebo | Placebo |
| 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 | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | MADRS Total Score Change From Baseline to Week 6 | Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms. | Posted | Mean | Standard Deviation | scores on the scale | 6 weeks |
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| Secondary | MADRS Response | A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score. | Posted | Mar 2011 | Number | Participants | 6 weeks |
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| Secondary | MADRS Remission | A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6 | Posted | Mar 2011 | Number | Participants | 6 weeks |
|
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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 | AZD2066 | AZD2066 12 mg, 18 mg | 1 | 40 | 21 | 40 | ||
| EG001 | Duloxetine | Duloxetine 30 mg, 60 mg | 0 | 47 | 30 | 47 | ||
| EG002 | Placebo | Placebo | 0 | 44 | 16 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian mass | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 13.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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No publication or presentation of results until the earlier of 1) the date of the first study results publication or 2) 18 months after completion or termination of the study.
AZ review 60 days prior submission and AZ has the possibility to further delay publication for an additional 90 days
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | 645895 | +44 1509 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C587779 | AZD2066 |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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