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JNJ-18038683

Phase 2

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

JNJ-18038683 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2007

JNJ-18038683 target and mechanism

Molecular targetHTR7
Target classAntagonist
ModalitySmall molecule

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

JNJ-18038683 clinical trials

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?

JNJ-18038683 is an investigational small molecule developed by Johnson & Johnson for Major Depressive Disorder. It is a Phase 2 psychiatry candidate and has not been approved for any use. It was studied in a single completed placebo-controlled trial in adults with moderate to severe depression.

What does JNJ-18038683 target?

JNJ-18038683 targets HTR7, the serotonin 5-HT7 receptor, and acts as an antagonist. By blocking this receptor, the compound was designed to act on serotonin signaling pathways relevant to mood regulation. This mechanism distinguishes it from standard monoamine reuptake inhibitors used in depression.

Who makes JNJ-18038683?

JNJ-18038683 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is an internal psychiatry asset studied for Major Depressive Disorder.

What phase is JNJ-18038683 in?

JNJ-18038683 is in Phase 2 development for Major Depressive Disorder. It is investigational and has not been approved by the FDA or any other regulator. Its only recorded trial, NCT00566202, has been completed, and no trials are currently active.

What clinical trials is JNJ-18038683 in?

JNJ-18038683 was evaluated in one Phase 2 trial, NCT00566202, titled a safety and effectiveness study in patients with moderate to severe depression. The trial was completed, enrolled 67 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States.