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AZD2327

Phase 2

Anxious Major Depressive Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Nov 8, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00759395Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)PHASE2 COMPLETED 22Jan 1, 2009Oct 1, 2011Nov 8, 20121 United States
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Study Endpoints
Primary Endpoints
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 Endpoints
Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
Week 4
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
Randomization to week 4
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.
Randomization to week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD2327EXPERIMENTALAZD2327 3mg BID
PlaceboPLACEBO_COMPARATORPlacebo BID
Interventions
NameTypeDescription
AZD2327DRUGTablet, Oral, Daily
PlaceboDRUGTablet, Oral, Daily
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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