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VASOPRESSIN V1B RECEPTOR ANTAGONIST

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Sanofi|Last Updated: May 25, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

VASOPRESSIN V1B RECEPTOR ANTAGONIST · 1 trial · 1 indication

Phase 2 1
NCT01606384Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED100 Analytics
PHASE2COMPLETED
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
4 weeks

Secondary Endpoints

Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing
4 weeks
Number of patients with adverse events
Up to 6 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores
Baseline, 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORTwice daily
SSR149415 - 100mgEXPERIMENTALTwice daily
SSR149415 - 250mgEXPERIMENTALTwice daily

Interventions

NameTypeDescription
VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)DRUGPharmaceutical form: Capsule Route of administration: oral
PlaceboDRUGPharmaceutical form: Capsule Route of administration: Oral
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria : * Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) and the Mini International Neuropsychiatric Interview (MINI) criteria. Exclusion criteria: * Outpatients unwilling to be hos...

Countries:United States
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Frequently asked questions about VASOPRESSIN V1B RECEPTOR ANTAGONIST

What is VASOPRESSIN V1B RECEPTOR ANTAGONIST used for?

VASOPRESSIN V1B RECEPTOR ANTAGONIST is an investigational small molecule being developed for the treatment of Major Depressive Disorder. It is a vasopressin V1b receptor antagonist, and it is currently in Phase 2 clinical development.

What does VASOPRESSIN V1B RECEPTOR ANTAGONIST target?

VASOPRESSIN V1B RECEPTOR ANTAGONIST targets the vasopressin V1b receptor. By blocking this receptor, the drug is intended to modulate the hypothalamic-pituitary-adrenal axis, which is relevant to the pathophysiology of Major Depressive Disorder.

Who makes VASOPRESSIN V1B RECEPTOR ANTAGONIST?

VASOPRESSIN V1B RECEPTOR ANTAGONIST is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical development for Major Depressive Disorder.

What phase is VASOPRESSIN V1B RECEPTOR ANTAGONIST in?

VASOPRESSIN V1B RECEPTOR ANTAGONIST is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed for Major Depressive Disorder.

What clinical trials is VASOPRESSIN V1B RECEPTOR ANTAGONIST in?

VASOPRESSIN V1B RECEPTOR ANTAGONIST has one completed Phase 2 trial, identified as NCT01606384. This trial evaluated the potential effects of the drug on the hypothalamic-pituitary-adrenal axis in outpatients with Major Depressive Disorder, enrolling 100 participants in the United States.

Is VASOPRESSIN V1B RECEPTOR ANTAGONIST the same as SSR149415?

Yes, VASOPRESSIN V1B RECEPTOR ANTAGONIST is also known as SSR149415. The completed Phase 2 trial NCT01606384 evaluated the effects of SSR149415 on the hypothalamic-pituitary-adrenal axis in patients with Major Depressive Disorder.