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Org 34517

Phase 2

Depression | Small molecule | Psychiatry |Merck & Company, Inc.|Last Updated: Nov 26, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment273

FDA Designations

No designations recorded

Clinical trial landscape

Org 34517 · 1 trial · 3 indications

Phase 2 1
NCT00212797A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845)Depression
COMPLETED273 Analytics
PHASE2COMPLETED
A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845)
DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

PANSS positive symptoms subscale.
6 weeks

Secondary Endpoints

Ham-D17, CGI, Cognition, spermatogenesis
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Org 34517_1EXPERIMENTALlow dose Org 34517
Org 34517_2EXPERIMENTALhigh dose Org 34517
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Org 34517DRUGlow dose Org 34517
PlaceboDRUGplacebo
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * have provided voluntary written informed consent for trial participation after the scope and nature of the investigation were explained to them, and before starting any trial-related activities (before Screening); * be able to speak, read, understand, respond to questions, and...

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Frequently asked questions about Org 34517

What is Org 34517 used for?

Org 34517 is an investigational small molecule being studied for the treatment of depression, specifically as an adjunctive therapy in subjects with psychotic major depression. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development.

Who makes Org 34517?

Org 34517 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical development for the treatment of depression.

What phase is Org 34517 in?

Org 34517 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its efficacy and safety as adjunctive therapy in subjects with psychotic major depression.

What clinical trials has Org 34517 been in?

Org 34517 has been studied in one completed Phase 2 clinical trial, identified as NCT00212797. This randomized, double-blind, placebo-controlled study enrolled 273 participants and evaluated the efficacy and safety of two doses of Org 34517 as adjunctive therapy in subjects with psychotic major depression.

Is Org 34517 the same as any other drug?

Org 34517 is the primary name used for this investigational drug in clinical development. No alternative names have been established for this compound in the available clinical trial information.