Recent Updates
Recently added Catalysts

Org 34517

Phase 2

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

Org 34517 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Sep 2005

Org 34517 target and mechanism

ModalitySmall molecule

Also known as SCH 900636

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment289

FDA Designations

No designations recorded

Org 34517 clinical trials

Org 34517 · 2 trials · 3 indications

Phase 2 2
NCT00844922Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)Depressive Disorders
COMPLETED16 Analytics
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
Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)
Depressive DisordersUnlock trial 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

Safety and tolerability measures (vital signs, AEs)
4 weeks
PANSS positive symptoms subscale.
6 weeks

Secondary Endpoints

17-item Hamilton Rating Scale for Depression (HAMD) total score
4 weeks
proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response
4 weeks
proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response
4 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Org 34517EXPERIMENTALOrg 34517 titrated to 900 mg daily for 2 weeks
PlaceboPLACEBO_COMPARATOR -
Org 34517_1EXPERIMENTALlow dose Org 34517
Org 34517_2EXPERIMENTALhigh dose Org 34517

Interventions

NameTypeDescription
SCH 900636DRUGOrg 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the "usual treatment" for psychotic major depression.
PlaceboDRUGPlacebo
Org 34517DRUGlow dose Org 34517
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of previous trial 28130; * have a CGI of Severity score of 3 or greater at Day 43 of previous trial 28130 and at Day 1 of current trial 28133, or a lower score when the investigator is of the opinion that furth...

Unlock Eligibility Criteria

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.