Major Depressive Disorder
Conditions
Keywords
Depression
Brief summary
This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.
Detailed description
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.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed, written, and dated Informed Consent * Documented primary clinical diagnosis of Major Depressive Disorder
Exclusion criteria
* Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder * Patients whose current episode of depression started less than 4 weeks before enrollment * History of inadequate response of antidepressants during current depressive episode
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS Total Score Change From Baseline to Week 6 | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS Response | 6 weeks | A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score. |
| MADRS Remission | 6 weeks | A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6 |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
Patients with major depressive disorder were included.
Participants by arm
| Arm | Count |
|---|---|
| AZD2066 AZD2066 12 mg, 18 mg | 40 |
| Duloxetine Duloxetine 30 mg, 60 mg | 47 |
| Placebo Placebo | 44 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 3 | 1 |
| Overall Study | Patient could not swollow medication | 0 | 0 | 1 |
| Overall Study | Positive urine ethanol | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 3 | 1 |
| Overall Study | Study Closure | 14 | 14 | 17 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | AZD2066 | Duloxetine | Placebo | Total |
|---|---|---|---|---|
| Age Continuous | 42.2 Years | 39.9 Years | 38.4 Years | 40.1 Years |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 30 Participants | 77 Participants |
| Sex: Female, Male Male | 17 Participants | 23 Participants | 14 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 40 | 30 / 47 | 16 / 44 |
| serious Total, serious adverse events | 1 / 40 | 0 / 47 | 0 / 44 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD2066 | MADRS Total Score Change From Baseline to Week 6 | -13.1658 scores on the scale | Standard Deviation 2.11 |
| Duloxetine | MADRS Total Score Change From Baseline to Week 6 | -14.0271 scores on the scale | Standard Deviation 1.97 |
| Placebo | MADRS Total Score Change From Baseline to Week 6 | -14.1575 scores on the scale | Standard Deviation 2.16 |
Secondary
MADRS Remission
A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD2066 | MADRS Remission | 5 Participants |
| Duloxetine | MADRS Remission | 8 Participants |
| Placebo | MADRS Remission | 7 Participants |
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.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD2066 | MADRS Response | 9 Participants |
| Duloxetine | MADRS Response | 9 Participants |
| Placebo | MADRS Response | 9 Participants |