A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antidepressive Agents

Criteria

Inclusion Criteria:

• Diagnosis of Major Depressive Disorder (MDD); patients with a diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD to be the primary diagnosis

• A 17-item Hamilton Depression Rating Scale (HDRS17) total score =>18

• A HDRS17 anxiety/somatization factor score =>7

• Is receiving an antidepressant

Exclusion Criteria:

• Has other psychiatric condition, including, but not limited to, MDD with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia

• Has a length of current Major Depressive Episode (MDE) >6 months

• Has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year

• Not including the inadequate response to the current antidepressant, has more than 1 failed antidepressant treatment of adequate dose and duration in the current MDE