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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.

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Official Title

This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.

Study of Antidepressant Efficacy of a selective, high affinity enkephalinergic agonist in Anxious Major Depressive Disorder (AMDD)

Research Site

An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder

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 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.

Age Continuous

Gender, Male/Female

Hamilton Rating Scale for Depression (HAM-D) total score.

Hamilton Rating Scale for Anxiety (HAM-A) total score.

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.

Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D).

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 Depression (HAM-D)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.

The number of participants with at least 50% reduction of Hamilton Rating Scale for Anxiety (HAM-A)total score.

Overall Study

Screening for eligibility and wash-out of restricted medications.

Arms	Assigned Interventions
Experimental: AZD2327 AZD2327 3mg BID	Drug: AZD2327 Tablet, Oral, Daily
Placebo Comparator: Placebo Placebo BID	Drug: Placebo Tablet, Oral, Daily

Study of Antidepressant Efficacy of a selective, high affinity enkephalinergic agonist in Anxious Major Depressive Disorder (AMDD)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=244&filename=CSR-D0880C00021.pdf

CSR-D0880C00021.pdf

CSR-D0880C00021.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator