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ABT-436

Phase 1

Major Depressive Disorder | Small molecule | Psychiatry |AbbVie Inc.|Last Updated: Nov 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

ABT-436 · 1 trial · 1 indication

Phase 1 1
NCT01380704Safety and Pharmacodynamic Study of ABT-436 in Major Depressive DisorderMajor Depressive Disorder
COMPLETED51 Analytics
PHASE1COMPLETED
Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacology assays
Days -2, -1, 6, 7

Hormones in blood, urine and saliva samples

ABT-436 drug levels
Days 6, 7

ABT-436 drug levels in plasma

Vital signs
Days -2 through 8, 14, 30

Blood pressure, pulse

Clinical safety labs
Days -2, 2, 5, 8

Hematology, chemistry, urinalysis

Secondary Endpoints

Psychiatric symptom scales
Days -2, 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ABT-436DRUGQD Days 1-7
Matching PlaceboDRUGQD Days 1-7
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria 1\. Age between 18 to 55 years, inclusive. 2. Body Mass Index is 20 to 35 kg/m2, inclusive. 3. A primary Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of major depressive disorder. 4\. Mild-to-moderate depressive symp...

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Frequently asked questions about ABT-436

What is ABT-436 used for?

ABT-436 is an investigational small molecule being studied for the treatment of Major Depressive Disorder. It is being developed by AbbVie Inc. and is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for this psychiatric condition.

Who makes ABT-436?

ABT-436 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in Phase 1 clinical development for Major Depressive Disorder.

What phase is ABT-436 in?

ABT-436 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is being studied for Major Depressive Disorder.

What clinical trials is ABT-436 in?

ABT-436 has one completed clinical trial, NCT01380704, titled "Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder." This Phase 1 trial enrolled 51 participants and was a randomized, double-blind, placebo-controlled study.

Is ABT-436 FDA approved?

No, ABT-436 is not FDA approved. It is an investigational drug in Phase 1 clinical development for Major Depressive Disorder. The drug is still being studied and has not been approved for any use.