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GW597599B

Phase 2

Depressive Disorder, Major | Small molecule | Psychiatry |GSK plc|Last Updated: Oct 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment372

FDA Designations

No designations recorded

Clinical trial landscape

GW597599B · 1 trial · 1 indication

Phase 2 1
NCT00048204A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive DisorderDepressive Disorder, Major
COMPLETED372 Analytics
PHASE2COMPLETED
A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder
Depressive Disorder, MajorUnlock trial analytics

Study Endpoints

Primary Endpoints

Hamilton Depression Rating Scale
8 Weeks

Secondary Endpoints

Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale
8 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GW597599BDRUG -
paroxetineDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients meet the diagnosis of Major Depressive Disorder (MDD). Exclusion Criteria: * Patients with a primary diagnosis other than MDD. * Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder. * Patients receivin...

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Frequently asked questions about GW597599B

What is GW597599B used for?

GW597599B is an investigational small molecule being studied for the treatment of Major Depressive Disorder. It is currently in Phase 2 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.

Who makes GW597599B?

GW597599B is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the drug's potential in treating Major Depressive Disorder.

What phase is GW597599B in?

GW597599B is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory agencies. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is GW597599B in?

GW597599B has been studied in one clinical trial, identified as NCT00048204. This was a Phase 2 study titled 'A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder,' which enrolled 372 participants and has been completed.

Is GW597599B FDA approved?

No, GW597599B is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Major Depressive Disorder. The drug has not completed the clinical trial process required for regulatory approval and remains under investigation.