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

NCT ID: NCT01582815

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-11-30

Brief 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.

Detailed 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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-40411813

Group Type: EXPERIMENTAL

JNJ-40411813

Intervention Type: DRUG

Type= range, unit= mg, number= 25 to 150, form= capsules, route= oral administration. JNJ-40411813 will be administered twice daily during 8 weeks, following fixed and flexible schedules in which the dose can range from 25 mg to 150 mg.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Form= capsule, route= oral administration. Matching placebo will be administered twice daily during 8 weeks.

Interventions

JNJ-40411813

Type= range, unit= mg, number= 25 to 150, form= capsules, route= oral administration. JNJ-40411813 will be administered twice daily during 8 weeks, following fixed and flexible schedules in which the dose can range from 25 mg to 150 mg.

Intervention Type: DRUG

Placebo

Form= capsule, route= oral administration. Matching placebo will be administered twice daily during 8 weeks.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Burgas, , Bulgaria

Kazanlak, , Bulgaria

Rousse, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Baja, , Hungary

Budapest, , Hungary

Gyõr, , Hungary

Kalocsa, , Hungary

Chisinau, , Moldova

Arad, , Romania

Iași, , Romania

Nizny Novgorod, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

St-Peterburg, , Russia

Tomsk, , Russia

Donetsk, , Ukraine

Hlevakha, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Smila, , Ukraine

Uzhhorod, , Ukraine

Village Stepanovka Kherson, , Ukraine

Countries

Bulgaria; Hungary; Moldova; Romania; Russia; Ukraine

Other Identifiers

40411813DAX2001

Identifier Type: OTHER

Identifier Source: secondary_id

2011-006121-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100851

Identifier Type: -

Identifier Source: org_study_id