Anxious Major Depressive Disorder
Conditions
Keywords
Anxious Major Depressive Disorder
Brief summary
This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.
Interventions
DRUGAZD2327
Tablet, Oral, Daily
DRUGPlacebo
Tablet, Oral, Daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures * Diagnosis of major depressive disorder without psychotic features (MDD)
Exclusion criteria
* A history of substance or alcohol abuse within the past 6 months or dependence within 1 year of enrollment as defined by DSM-IV criteria. * Women that are pregnant or lactating * History of pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression (HAM-D) Total Score. | Week 4 | Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. |
| Hamilton Rating Scale for Anxiety (HAM-A) Total Score. | Week 4 | The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). | Week 4 | Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome. Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. |
| The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. | Randomization to week 4 | Hamilton Rating Scale for Depression (HAM-D) response is defined as a \>= 50% reduction from randomization (baseline) in HAM-D total score. Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. |
| The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. | Randomization to week 4 | Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a \>= 50% reduction from randomization (baseline) in HAM-A total score. The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome. |
Countries
United States
Participant flow
Recruitment details
A single site, randomized, double blind, placebo-controlled, parallel group experimental study. Patients recruited between November 2008 and October 2011.
Pre-assignment details
Screening for eligibility and wash-out of restricted medications.
Participants by arm
| Arm | Count |
|---|---|
| AZD2327 AZD2327 3mg BID Tablet, Oral, Daily | 13 |
| Placebo Placebo BID, Tablet, Oral, Daily | 9 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | AZD2327 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 40 Years STANDARD_DEVIATION 12.2 | 48.7 Years STANDARD_DEVIATION 11.3 | 44.35 Years STANDARD_DEVIATION 11.75 |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 13 | 9 / 9 |
| serious Total, serious adverse events | 1 / 13 | 0 / 9 |
Outcome results
Primary
Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Time frame: Week 4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD2327 | Hamilton Rating Scale for Anxiety (HAM-A) Total Score. | 13.029 Units on a scale | Standard Error 2.257 |
| Placebo | Hamilton Rating Scale for Anxiety (HAM-A) Total Score. | 17.736 Units on a scale | Standard Error 2.712 |
Primary
Hamilton Rating Scale for Depression (HAM-D) Total Score.
Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Time frame: Week 4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD2327 | Hamilton Rating Scale for Depression (HAM-D) Total Score. | 14.249 Units on a scale | Standard Error 2.152 |
| Placebo | Hamilton Rating Scale for Depression (HAM-D) Total Score. | 16.307 Units on a scale | Standard Error 2.604 |
Secondary
Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome. Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Time frame: Week 4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD2327 | Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). | 1.373 Units on a scale | Standard Error 0.313 |
| Placebo | Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). | 2.128 Units on a scale | Standard Error 0.379 |
Secondary
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.
Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a \>= 50% reduction from randomization (baseline) in HAM-A total score. The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Time frame: Randomization to week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD2327 | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. | 7 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. | 3 Participants |
Secondary
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
Hamilton Rating Scale for Depression (HAM-D) response is defined as a \>= 50% reduction from randomization (baseline) in HAM-D total score. Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Time frame: Randomization to week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD2327 | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. | 5 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. | 4 Participants |