Major Depressive Disorder Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Secondary | 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. | No |
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