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JNJ-18038683

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Aug 6, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-18038683 · 1 trial · 1 indication

Phase 2 1
NCT00566202A Safety and Effectiveness Study of JNJ-18038683 in Patients With Moderate to Severe DepressionMajor Depressive Disorder
COMPLETED67 Analytics
PHASE2COMPLETED
A Safety and Effectiveness Study of JNJ-18038683 in Patients With Moderate to Severe Depression
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Explore the effectiveness of JNJ-18038683 in patients with moderate to severe depression as determined by accepted clinical assessments done throughout the study.
Clinical assessments to evaluate depression will be done 8 times at weekly visits from baseline through the Week 7 visit.

Secondary Endpoints

Explore the safety and tolerability of JNJ-18038683 in patients with moderate to severe depression by assessing adverse events, vital signs, laboratory test results, ECGs and physical exams.
Vital signs will be collected weekly throughout the study; ECGs will be collected at screening, baseline, Wks 3 and 7; Laboratory test will be collected at screening, baseline, and Wks 1,3,5,7 and 8. Adverse Events will be throughout the study.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-18038683EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
EscitalopramACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGForm= capsule, route= oral use. Administration once daily for 8 weeks.
EscitalopramDRUGType= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 20 mg daily for 6 weeks, and 10 mg daily for 1 week.
JNJ-18038683DRUGType= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 10 or 20 mg daily for 6 weeks, and placebo daily for 1 week.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Diagnosed with moderate to severe major depressive disorder * Willing to use acceptable methods of birth control throughout the study and for 3 months after * In good general health Exclusion Criteria: * No history or current diagnosis of other psychiatric conditions such as...

Countries:United States
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Frequently asked questions about JNJ-18038683

What is JNJ-18038683 used for?

JNJ-18038683 is an investigational small molecule being studied for the treatment of Major Depressive Disorder. It is in Phase 2 clinical development and has been evaluated in a completed clinical trial involving patients with moderate to severe depression.

Who makes JNJ-18038683?

JNJ-18038683 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 2 clinical development for Major Depressive Disorder.

What phase is JNJ-18038683 in?

JNJ-18038683 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial for the drug has been completed.

What clinical trials is JNJ-18038683 in?

JNJ-18038683 has been studied in one completed Phase 2 clinical trial, identified as NCT00566202. This trial was a randomized, double-blind, placebo-controlled study that enrolled 67 participants with Major Depressive Disorder in the United States.

Is JNJ-18038683 FDA approved?

JNJ-18038683 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Major Depressive Disorder. Its safety and effectiveness have not been established, and it remains under clinical investigation.