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

NCT ID: NCT00566202

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-12-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

JNJ-18038683

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

JNJ-18038683

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

JNJ-18038683

Intervention Type: DRUG

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.

Escitalopram

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

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.

Interventions

Placebo

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Little Rock, Arkansas, United States

Beverly Hills, California, United States

Glendale, California, United States

San Diego, California, United States

Bradenton, Florida, United States

Maitland, Florida, United States

Orlando, Florida, United States

Atlanta, Georgia, United States

Eagle, Idaho, United States

Chicago, Illinois, United States

Prairie Village, Kansas, United States

Topeka, Kansas, United States

Baton Rouge, Louisiana, United States

Shreveport, Louisiana, United States

Nutley, New Jersey, United States

Brooklyn, New York, United States

Cedarhurst, New York, United States

Fresh Meadows, New York, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Norristown, Pennsylvania, United States

Memphis, Tennessee, United States

Austin, Texas, United States

Irving, Texas, United States

Richmond, Virginia, United States

Countries

United States

Other Identifiers

C-2007-007

Identifier Type: OTHER

Identifier Source: secondary_id

CR014617

Identifier Type: -

Identifier Source: org_study_id

NCT00761293

Identifier Type: -

Identifier Source: nct_alias