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SCH 900636

Phase 2

Depressive Disorders | Small molecule | Psychiatry |Merck & Company, Inc.|Last Updated: Dec 31, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

SCH 900636 · 1 trial · 3 indications

Phase 2 1
NCT00844922Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)Depressive Disorders
COMPLETED16 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

Study Endpoints

Primary Endpoints

Safety and tolerability measures (vital signs, AEs)
4 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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

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

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
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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...

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Frequently asked questions about SCH 900636

What is SCH 900636 used for?

SCH 900636 is an investigational small molecule being studied for the treatment of depressive disorders, including psychotic disorders and depression. It is in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes SCH 900636?

SCH 900636 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is SCH 900636 in?

SCH 900636 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. One Phase 2 trial has been completed, and the drug is no longer in active clinical trials.

What clinical trials is SCH 900636 in?

SCH 900636 has been studied in one completed Phase 2 clinical trial, identified as NCT00844922. This trial evaluated the safety of SCH 900636 in patients who had previously received the drug in an earlier study, enrolling 16 participants.

Is SCH 900636 the same as Org 34517?

SCH 900636 is also known as Org 34517. The completed clinical trial NCT00844922 references Org 34517 in its title, indicating that these names refer to the same investigational drug being developed by Merck.