A Safety and Effectiveness Study of JNJ-18038683 in Patients With Moderate to Severe Depression
A Phase IIa Multicenter, Randomized, Double-blind, Double-dummy, and Placebo- and Active Controlled Study to Investigate the Safety and Efficacy of JNJ-18038683 Administered to Subjects With Major Depressive Disorder
2 other identifiers
interventional
67
1 country
26
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of JNJ-18038683 compared to escitalopram and placebo in patients with moderate to severe depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 major-depressive-disorder
Started Dec 2007
Shorter than P25 for phase_2 major-depressive-disorder
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedFirst Posted
Study publicly available on registry
December 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedAugust 6, 2014
August 1, 2014
1 year
November 29, 2007
August 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (3)
JNJ-18038683
EXPERIMENTALPlacebo
PLACEBO COMPARATOREscitalopram
ACTIVE COMPARATORInterventions
Form= capsule, route= oral use. Administration once daily for 8 weeks.
Type= 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.
Type= 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No history or current diagnosis of other psychiatric conditions such as bipolar disorder, psychotic disorder, general anxiety disorder, anorexia, obsessive compulsive disorder, post traumatic stress disorder, antisocial personality disorder, mental retardation, pervasive developmental disorder, or cognitive disorder
- No history or presence of drug abuse
- No use of prescription medications or herbal medications other than hormone replacement therapies
- No prior history of heart disease or current significant blood, lung, kidney, liver, heart, breathing, neurologic or thyroid disorders
- No patients who are either pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Maitland, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Eagle, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Topeka, Kansas, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Nutley, New Jersey, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
Cedarhurst, New York, United States
Unknown Facility
Fresh Meadows, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Norristown, Pennsylvania, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Irving, Texas, United States
Unknown Facility
Richmond, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2007
First Posted
December 3, 2007
Study Start
December 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
August 6, 2014
Record last verified: 2014-08