Clinical trial NCT00566202: A Safety and Effectiveness Study of JNJ-18038683 in Patients With Moderate to Severe Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
JNJ-18038683
Escitalopram
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2007-12-03
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study is being done to assess safety and tolerability and to explore the effectiveness of a new, experimental drug in the treatment of moderate to severe depression. Approximately 225 patients with depression will be recruited for the study. Patients who meet study criteria will need to stop taking any depression medications they are currently using. They will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of receiving 20 mg JNJ-18038683, 20 mg escitalopram, or placebo. Placebo has no active drug. Escitalopram is a drug currently approved to treat depression. This is a blinded study, ie the patient, the study doctor, and the study sponsor will not know what treatment the patient receives until all patients complete the study. Patients receiving either escitalopram or JNJ-18038683 will be titrated up to their assigned dose, receiving 10 mg doses for one week prior to increasing to 20 mg. Patients who are not able to tolerate 20 mg of JNJ-18038683 will be allowed to drop down to the 10 mg dose at any time after the titration period. Patients taking 20 mg escitalopram will receive 10 mg at their final week to taper off of the drug. Patients will receive a drug blister card at each weekly visit containing drug for the upcoming week. The study doctor and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will return weekly for 9 additional study visits. After completing the study, patients may resume other depression medications. Medical and psychiatric history, physical examination, blood pressure, heart rate, temperature, weight and electrocardiograms (ECGs) will be checked periodically. Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level. Questionnaires relating to depression, sleep and sexual experience will be administered throughout the study. Each day for nine weeks, patients will take orally two JNJ-18038683 tablets, active and/or placebo, and two escitalopram capsules, active and/or placebo.

Eligibility criteria: 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

Primary outcomes:
measure: Explore the effectiveness of JNJ-18038683 in patients with moderate to severe depression as determined by accepted clinical assessments done throughout the study.
timeFrame: Clinical assessments to evaluate depression will be done 8 times at weekly visits from baseline through the Week 7 visit.
Secondary outcomes:
measure: 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.
timeFrame: 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.
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Glendale
country: United States
state: California
city: San Diego
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Eagle
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Prairie Village
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Baton Rouge
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Nutley
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Cedarhurst
country: United States
state: New York
city: Fresh Meadows
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Norristown
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
role: STUDY_DIRECTOR
References: