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AZD2327

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

AZD2327 · 1 trial · 1 indication

Phase 2 1
NCT00759395Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)Anxious Major Depressive Disorder
COMPLETED22 Analytics
PHASE2COMPLETED
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
Anxious Major Depressive DisorderUnlock trial analytics

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 to 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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Frequently asked questions about AZD2327

What is AZD2327 used for in Anxious Major Depressive Disorder?

AZD2327 is an investigational small molecule being studied for the treatment of Anxious Major Depressive Disorder (AMDD). It was evaluated in a Phase 2 clinical trial as a potential antidepressant for this condition. The drug is not approved and remains in clinical development.

What does AZD2327 target?

AZD2327 is described as a selective, high affinity enkephalinergic agonist. It acts on the enkephalinergic system, which is involved in modulating mood and stress responses. This mechanism was studied for its potential antidepressant effects in Anxious Major Depressive Disorder.

Who makes AZD2327?

AZD2327 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company conducted a Phase 2 clinical trial to evaluate the drug's efficacy in patients with Anxious Major Depressive Disorder.

What phase is AZD2327 in?

AZD2327 is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug is still investigational and has not received regulatory approval. Its development status reflects an ongoing evaluation of its safety and efficacy for Anxious Major Depressive Disorder.

What clinical trials is AZD2327 in?

AZD2327 has one completed clinical trial registered as NCT00759395, titled 'Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)'. This Phase 2 study enrolled 22 participants in the United States and was placebo-controlled, randomized, and double-blind.

Is AZD2327 the same as an enkephalinergic agonist?

AZD2327 is characterized as a selective, high affinity enkephalinergic agonist, meaning it activates the enkephalinergic system. This mechanism was the focus of its Phase 2 trial for Anxious Major Depressive Disorder. No other alternative names for the drug have been reported.