A Safety and Efficacy Study of JNJ26489112 in Patients With Treatment-Resistant Major Depressive Disorder

This study has been terminated.
(Study was terminated due to sponsor portfolio decision.)
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01114698
First received: April 22, 2010
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of JNJ26489112 compared with an active control (Venlafaxine XR) and placebo in patients with Treatment-Resistant Major Depressive Disorder.


Condition Intervention Phase
Depression
Drug: Venlafaxine XR
Drug: Placebo
Drug: JNJ26489112
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group, Active- and Placebo-Controlled Study to Assess the Efficacy and Safety of JNJ26489112 in Adult Subjects With Treatment-Resistant Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Change from baseline in Montgomery-Asberg Depression Rating Scale (10 item diagnostic questionnaire measuring the severity of depression) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: At each weekly visit during the study (screening through completion of the study [Week 7]) ] [ Designated as safety issue: No ]
  • Mean Change in Inventory of Depressive Symptoms (IDS) and Clinical Global Impression (CGI) [ Time Frame: At Visits 1, 2, 4, 6, 8, and 9 (Screening, Baseline, Week 2, Week 4, Week 6, and Week 9) ] [ Designated as safety issue: No ]
  • Findings from ophthalmologic examinations [ Time Frame: Before the first dose of study drug, at Week 3, and after the last dose in the double-blind phase of the study (Week 7 or at the time of early termination from the study) ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JNJ26489112 Drug: JNJ26489112
JNJ26489112 500 mg/day orally administered once daily as 2 capsules for the first 3 weeks, then dose may be increased to 1000 mg/day by week 4.
Active Comparator: Venlafaxine XR Drug: Venlafaxine XR
Venlafaxine XR 75 mg/day administered orally once daily as 2 capsules identical in appearance to JNJ26489112 during the first week increased to 150 mg/day during weeks 2 through 6.
Placebo Comparator: Placebo Drug: Placebo
Placebo: 2 capsules identical in appearance to JNJ26489112 and venlafaxine XR orally administered once daily for 6 weeks.

Detailed Description:

This is a randomized (patients assigned to treatment groups by chance), double-blind (neither the study physician nor the patient will know the identification of treatment assigned), active- and placebo-controlled study to assess the efficacy and safety of JNJ26489112 in adult patients with treatment-resistant major depressive disorder (MDD). The active control used in the study is venlafaxine extended-release [XR], an antidepressant drug used to treat patients with MDD. A target of 150 patients will be randomly assigned (like flipping a coin) to 1 of 3 treatment groups with approximately 50 patients planned per treatment group. This study consists of a screening phase of up to 4 weeks, a 6-week double-blind treatment phase, and a safety follow-up period that includes a 1-week taper phase (described below). During the screening phase, patients who meet entry criteria for the study will be tapered off their current psychotropic medications (medications affecting the mind or mood or other mental processes) prior to randomization in the double-blind treatment phase of the study. In the double-blind treatment phase, patients will be randomly assigned to receive either 2 capsules of JNJ26489112, venlafaxine XR (the active comparator), or placebo (a sugar pill) once daily for 6 weeks. Upon completion of the double-blind treatment phase or when patients discontinue study drug at any time point during the double-blind treatment phase, study medication will be tapered and/or discontinued in a blinded manner over a 1-week period. A Data Monitoring Committee (DMC) made up of individuals not involved in the conduct of the study will monitor safety during the study. The primary outcome measure will be the change from baseline to end point (after 6 weeks of treatment or at the time of early withdrawal from the study) in the total score from the Montgomery-Asberg Depression Rating Scale (MADRS, a scale that physicians use to measure the severity of depression in patients and changes in depression due to antidepressant treatment). Patient safety will be monitored during the study by evaluating adverse events (side effects) reported and findings from clinical laboratory test results, 12-lead electrocardiograms (ECGs), vital sign measurements, body weight measurements and physical, neurologic, and ophthalmologic examinations performed. Blood samples for assessing pre- and post dose levels of JNJ26489112 or venlafaxine will be obtained at protocol-specified time points during the study. In addition, a blood sample will be obtained from all enrolled patients at Visit 2 for pharmacogenomics research (research to help identify genetic markers of response, to explain variability in the data, or to address emerging clinical issues). Patients will receive double-blind treatment with 2 capsules of JNJ26489112 (500 mg/day during the first 3 weeks that may be increased up to 1000 mg/day by week 4), venlafaxine XR (75 mg/day during week 1 increased to 150 mg/day during weeks 2-6]), or placebo orally (by mouth) with food once daily for 6 weeks. After 6 weeks, venlafaxine XR 150 mg/day will be tapered to one 75 mg/day capsule for 1 week and patients receiving JNJ26489112 or placebo will be switched to 1 capsule of placebo for 1 week.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revised (DMS-IV-TR) criteria for diagnosis of moderate or severe major depression without psychotic features
  • Have a score >=40 on the subject-rated Inventory of Depressive Symptoms-Self-Report - 30-item (IDS-SR30) At Screening (Visit 1) and Randomization (Visit 2)
  • Have a history of inadequate treatment response (as defined by failure to improve with a trial of adequate dosage and duration) with 2 antidepressants during the current episode, but no more than 4 antidepressant failures for lifetime
  • Be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, blood chemistry, hematology, urinalysis, and electrocardiogram (ECG)
  • Be within a body mass index (BMI) of >=18 and <35 kg/m2 at Screening (Visit 1)

Exclusion Criteria:

  • Have a DSM-IV diagnosis of current (active) generalized anxiety disorder, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa
  • Have a history or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders, mood disorder with postpartum onset, somatoform disorders, chronic fatigue syndrome or fibromyalgia
  • Have a history of previous non-response to an adequate treatment with venlafaxine XR (defined as >=6 weeks of 75 to 150 mg/day or more)
  • Have documented disease of the central nervous system that could interfere with the study assessments (including but not limited to: stroke, tumor, multiple sclerosis, Parkinson's disease, Alzheimer's disease, Huntington's disease, seizure disorder requiring current anticonvulsants, history of brain injury or trauma, or neurosyphilis)
  • Have a history of alcohol or substance (except nicotine and caffeine) dependence or abuse according to DSM-IV criteria in the past 12 months prior to Screening
  • Received an experimental drug or used an experimental medical device within 60 days before the planned start of treatment (Day 1) or have participated in 2 or more clinical studies in the previous 1 year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114698

Locations
United States, California
Arcadia, California, United States
Escondido, California, United States
San Diego, California, United States
United States, Connecticut
Hartford, Connecticut, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Naperville, Illinois, United States
United States, New York
Brooklyn, New York, United States
United States, Ohio
Garfield Heights, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Utah
Murray, Utah, United States
Salt Lake City, Utah, United States
United States, Wisconsin
Middleton, Wisconsin, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01114698     History of Changes
Other Study ID Numbers: CR016579, 26489112MDD2001
Study First Received: April 22, 2010
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Depression
Major Depressive Disorder
Venlafaxine XR (EFFEXOR XR)
26489112
JNJ26489112

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014