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

NCT01114698 | Terminated Phase 2 DMC

• 2 other identifiers: CR01657926489112MDD2001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Major Depressive Disorder; Venlafaxine XR (EFFEXOR XR); 26489112; JNJ26489112

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Montgomery-Asberg Depression Rating Scale (10 item diagnostic questionnaire measuring the severity of depression)

  Baseline and 6 weeks

Secondary Outcomes (3)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  At each weekly visit during the study (screening through completion of the study [Week 7])

• Mean Change in Inventory of Depressive Symptoms (IDS) and Clinical Global Impression (CGI)

  At Visits 1, 2, 4, 6, 8, and 9 (Screening, Baseline, Week 2, Week 4, Week 6, and Week 9)

• Findings from ophthalmologic examinations

  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)

Study Arms (3)

JNJ26489112

EXPERIMENTAL

Drug: JNJ26489112

Venlafaxine XR

ACTIVE COMPARATOR

Drug: Venlafaxine XR

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Venlafaxine XR DRUG

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.

Venlafaxine XR

Placebo DRUG

Placebo: 2 capsules identical in appearance to JNJ26489112 and venlafaxine XR orally administered once daily for 6 weeks.

Placebo

JNJ26489112 DRUG

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.

JNJ26489112

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (14)

Unknown Facility

Arcadia, California, United States

Location

Unknown Facility

Escondido, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Hartford, Connecticut, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Naperville, Illinois, United States

Location

Unknown Facility

Brooklyn, New York, United States

Location

Unknown Facility

Garfield Heights, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Murray, Utah, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Middleton, Wisconsin, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

N-((6-chloro-2,3-dihydrobenzo(1,4)dioxin-2-yl)methyl)sulfamide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: May 3, 2010
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (14)