A Safety and Effectiveness Study of JNJ-18038683 in Patients With Moderate to Severe Depression

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00566202

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Placebo Drug: Escitalopram Drug: JNJ-18038683	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-18038683	Drug: Placebo Form= capsule, route= oral use. Administration once daily for 8 weeks. Drug: JNJ-18038683 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.
Placebo Comparator: Placebo	Drug: Placebo Form= capsule, route= oral use. Administration once daily for 8 weeks. Drug: JNJ-18038683 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.
Active Comparator: Escitalopram	Drug: Escitalopram 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.

Arm

Intervention/Treatment

Experimental: JNJ-18038683

Drug: Placebo

Form= capsule, route= oral use. Administration once daily for 8 weeks.

Drug: JNJ-18038683

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.

Placebo Comparator: Placebo

Drug: Placebo

Form= capsule, route= oral use. Administration once daily for 8 weeks.

Drug: JNJ-18038683

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.

Active Comparator: Escitalopram

Drug: Escitalopram

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Little Rock	Arkansas	United States
2	Beverly Hills	California	United States
3	Glendale	California	United States
4	San Diego	California	United States
5	Bradenton	Florida	United States
6	Maitland	Florida	United States
7	Orlando	Florida	United States
8	Atlanta	Georgia	United States
9	Eagle	Idaho	United States
10	Chicago	Illinois	United States
11	Prairie Village	Kansas	United States
12	Topeka	Kansas	United States
13	Baton Rouge	Louisiana	United States
14	Shreveport	Louisiana	United States
15	Nutley	New Jersey	United States
16	Brooklyn	New York	United States
17	Cedarhurst	New York	United States
18	Fresh Meadows	New York	United States
19	Cincinnati	Ohio	United States
20	Oklahoma City	Oklahoma	United States
21	Portland	Oregon	United States
22	Norristown	Pennsylvania	United States
23	Memphis	Tennessee	United States
24	Austin	Texas	United States
25	Irving	Texas	United States
26	Richmond	Virginia	United States

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.