Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00759395
First received: September 24, 2008
Last updated: October 10, 2012
Last verified: October 2012
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Results First Received: October 10, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Condition: |
Anxious Major Depressive Disorder |
| Interventions: |
Drug: AZD2327 Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| A single site, randomized, double blind, placebo-controlled, parallel group experimental study. Patients recruited between November 2008 and October 2011. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Screening for eligibility and wash-out of restricted medications. |
Reporting Groups
| Description | |
|---|---|
| AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| Placebo | Placebo BID, Tablet, Oral, Daily |
Participant Flow: Overall Study
| AZD2327 | Placebo | |
|---|---|---|
| STARTED | 13 | 9 |
| COMPLETED | 11 | 7 |
| NOT COMPLETED | 2 | 2 |
| Adverse Event | 1 | 0 |
| Withdrawal by Subject | 1 | 0 |
| Lack of Efficacy | 0 | 2 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| Placebo | Placebo BID, Tablet, Oral, Daily |
| Total | Total of all reporting groups |
Baseline Measures
| AZD2327 | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
13 | 9 | 22 |
|
Age
[units: Years] Mean ± Standard Deviation |
40 ± 12.2 | 48.7 ± 11.3 | 44.35 ± 11.75 |
|
Gender
[units: Participants] |
|||
| Female | 7 | 5 | 12 |
| Male | 6 | 4 | 10 |
Outcome Measures
| 1. Primary: | Hamilton Rating Scale for Depression (HAM-D) Total Score. [ Time Frame: Week 4 ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Hamilton Rating Scale for Depression (HAM-D) Total Score. |
| Measure Description | 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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| Placebo | Placebo BID, Tablet, Oral, Daily |
Measured Values
| AZD2327 | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
13 | 9 |
|
Hamilton Rating Scale for Depression (HAM-D) Total Score.
[units: Units on a scale] Least Squares Mean ± Standard Error |
14.249 ± 2.152 | 16.307 ± 2.604 |
No statistical analysis provided for Hamilton Rating Scale for Depression (HAM-D) Total Score.
| 2. Primary: | Hamilton Rating Scale for Anxiety (HAM-A) Total Score. [ Time Frame: Week 4 ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Hamilton Rating Scale for Anxiety (HAM-A) Total Score. |
| Measure Description | 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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| Placebo | Placebo BID, Tablet, Oral, Daily |
Measured Values
| AZD2327 | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
13 | 9 |
|
Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
[units: Units on a scale] Least Squares Mean ± Standard Error |
13.029 ± 2.257 | 17.736 ± 2.712 |
No statistical analysis provided for Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
| 3. Secondary: | Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). [ Time Frame: Week 4 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). |
| Measure Description |
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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| Placebo | Placebo BID, Tablet, Oral, Daily |
Measured Values
| AZD2327 | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
13 | 9 |
|
Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
[units: Units on a scale] Least Squares Mean ± Standard Error |
1.373 ± 0.313 | 2.128 ± 0.379 |
No statistical analysis provided for Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
| 4. Secondary: | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. [ Time Frame: Randomization to week 4 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. |
| Measure Description |
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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| Placebo | Placebo BID, Tablet, Oral, Daily |
Measured Values
| AZD2327 | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
13 | 9 |
|
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
[units: Participants] |
5 | 4 |
No statistical analysis provided for The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
| 5. Secondary: | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. [ Time Frame: Randomization to week 4 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. |
| Measure Description |
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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| Placebo | Placebo BID, Tablet, Oral, Daily |
Measured Values
| AZD2327 | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
13 | 9 |
|
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.
[units: Participants] |
7 | 3 |
No statistical analysis provided for The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00759395 History of Changes |
| Obsolete Identifiers: | NCT00738270 |
| Other Study ID Numbers: | D0880C00021 |
| Study First Received: | September 24, 2008 |
| Results First Received: | October 10, 2012 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Institutional Review Board |