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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: Placebo

Drug: JNJ-40411813

Study type

Interventional

Funder types

Industry

Identifiers

NCT01582815

2011-006121-26 (EudraCT Number)

CR100851

40411813DAX2001 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a multicenter, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled study in adult patients with Major Depressive Disorder (MDD) with anxiety symptoms of relevant severity. The study will consist of 3 phases: a screening phase of up to 2 weeks, an 8-week double-blind treatment phase, and a 2-week post-treatment (follow up) phase. Patients will continue to take the same daily dose of their antidepressant (as directed by the investigator) at the same time of day, from screening through the end of the study, including the post-treatment phase. The total study duration for each patient will be approximately 12 weeks.

Enrollment

121 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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