Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD7268 | Experimental | The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only. |
|
| Placebo | Placebo Comparator | The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only. |
|
| Escitalopram | Active Comparator | The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7268 | Drug | 15 mg, oral, twice daily (BID) |
| |
| Escitalopram |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4. | MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) Response | Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
Patients were required to discontinue current treatment for MDD at least 7 days prior to randomization (14 days prior to Day 1 for monoamine oxidase inhibitors [MAOIs] and 28 days prior to Day 1 for fluoxetine). Patients not taking medications for MDD at enrollment could be randomized once eligibility was confirmed.
A total of 18 centers were inititated with first patient enrolled on 16 November 2009 and last patient completed on 15 April 2010. A total of 430 patients were enrolled with 247 qualified patients allocated to randomized treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AZD7268 | AZD7268 15 mg twice per day (BID), placebo matching escitalopram |
| FG001 | Placebo | Placebo matching both AZD7268 and escitalopram |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
20 mg, oral, once daily (QD) |
|
| Placebo capsules | Drug | Placebo capsules to match AZD7268 |
|
| Placebo tablets | Drug | Placebo tablets to match encapsulated escitalopram |
|
| Week 4 |
| Montgomery-Åsberg Depression Rating Scale (MADRS) Remission | Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)] | Week 4 |
| Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4. | HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Baseline, Week 4 |
| Clinical Global Impression - Severity (CGI-S) Score Change From Baseline | CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 ("Normal, not ill") to 7 ("Among the most extremely ill patients"). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Baseline, Week 4 |
| Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline | HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Baseline, Week 4 |
| Garden Grove |
| California |
| United States |
| Research Site | San Diego | California | United States |
| Research Site | New Haven | Connecticut | United States |
| Research Site | Bradenton | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Rockville | Maryland | United States |
| Research Site | Cedarhurst | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Dayton | Ohio | 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 |
| FG002 | Escitalopram | Escitalopram 20 mg once per day(QD) Placebo matching AZD7268 |
| Patients Received Treatment |
|
| Full Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD7268 | AZD7268 15 mg twice per day (BID), placebo matching escitalopram |
| BG001 | Placebo | Placebo matching both AZD7268 and escitalopram |
| BG002 | Escitalopram | Escitalopram 20 mg once per day(QD) Placebo matching AZD7268 |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Montgomery-Åsberg Depression Rating Scale (MADRS) total score at baseline | MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Hamilton Rating Scale for Depression (HAM-D) total score at baseline | HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Mean | Standard Deviation | scores on a scale |
|
| 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 | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4. | MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Week 4 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Montgomery-Åsberg Depression Rating Scale (MADRS) Response | Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)] | Posted | Number | Participants | Week 4 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Montgomery-Åsberg Depression Rating Scale (MADRS) Remission | Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)] | Posted | Number | Participants | Week 4 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4. | HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Week 4 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Severity (CGI-S) Score Change From Baseline | CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 ("Normal, not ill") to 7 ("Among the most extremely ill patients"). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Week 4 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline | HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Week 4 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD7268 | AZD7268 15 mg twice per day (BID), placebo matching escitalopram | 0 | 96 | 36 | 96 | ||
| EG001 | Placebo | Placebo matching both AZD7268 and escitalopram | 0 | 99 | 33 | 99 | ||
| EG002 | Escitalopram | Escitalopram 20 mg once per day(QD) Placebo matching AZD7268 | 0 | 50 | 26 | 50 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Libido Decreased | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
No publication or presentation of results until the earlier of the publication of the first multi-center publication and the second anniversary of the completion of the multi-center study at all sites. Sponsor must receive a copy of proposed manuscript for review and comment at least 60 days prior to its submission for publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Other |
|
|
|
|
|
|