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

August 1, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Beverly Hills, California, United States
      • Glendale, California, United States
      • San Diego, California, United States
    • Florida
      • Bradenton, Florida, United States
      • Maitland, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Idaho
      • Eagle, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kansas
      • Prairie Village, Kansas, United States
      • Topeka, Kansas, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Shreveport, Louisiana, United States
    • New Jersey
      • Nutley, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • Cedarhurst, New York, United States
      • Fresh Meadows, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Norristown, Pennsylvania, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Irving, Texas, United States
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Explore the effectiveness of JNJ-18038683 in patients with moderate to severe depression as determined by accepted clinical assessments done throughout the study.
Time Frame: Clinical assessments to evaluate depression will be done 8 times at weekly visits from baseline through the Week 7 visit.
Clinical assessments to evaluate depression will be done 8 times at weekly visits from baseline through the Week 7 visit.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR014617
  • C-2007-007 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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