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

NCT01582815 | Completed Phase 2

• 3 other identifiers: CR10085140411813DAX20012011-006121-26
• Study Type: interventional
• Target: 121
• Locations: 6 countries
• Sites: 26

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Depression; Anxiety symptoms; JNJ-40411813

Outcome Measures

Primary Outcomes (1)

• The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score

  The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms.

  Baseline, Week 4

Secondary Outcomes (14)

• The change from baseline to endpoint on the Hamilton Depression Rating Scale (HDRS17) total score

  Baseline, Week 4

• The change from baseline to endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score

  Baseline, Week 4

• The change from baseline to endpoint in the Clinical Global Impression - Improvement (CGI-I) scale

  Baseline, Week 4

• The change from baseline to endpoint in the Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor total score

  Baseline, Week 4

• The change from baseline to endpoint in the HAM-D6 score

  Baseline, Week 4

Study Arms (2)

JNJ-40411813

EXPERIMENTAL

Drug: JNJ-40411813

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNJ-40411813 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.

JNJ-40411813

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (26)

Unknown Facility

Burgas, Bulgaria

Location

Unknown Facility

Kazanlak, Bulgaria

Location

Unknown Facility

Rousse, Bulgaria

Location

Unknown Facility

Sofia, Bulgaria

Location

Unknown Facility

Varna, Bulgaria

Location

Unknown Facility

Baja, Hungary

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Gyõr, Hungary

Location

Unknown Facility

Kalocsa, Hungary

Location

Unknown Facility

Chisinau, Moldova

Location

Unknown Facility

Arad, Romania

Location

Unknown Facility

Iași, Romania

Location

Unknown Facility

Nizny Novgorod, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Saratov, Russia

Location

Unknown Facility

St-Peterburg, Russia

Location

Unknown Facility

Tomsk, Russia

Location

Unknown Facility

Donetsk, Ukraine

Location

Unknown Facility

Hlevakha, Ukraine

Location

Unknown Facility

Kharkiv, Ukraine

Location

Unknown Facility

Kiev, Ukraine

Location

Unknown Facility

Lviv, Ukraine

Location

Unknown Facility

Odesa, Ukraine

Location

Unknown Facility

Smila, Ukraine

Location

Unknown Facility

Uzhhorod, Ukraine

Location

Unknown Facility

Village Stepanovka Kherson, Ukraine

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Anxiety Disorders

Interventions

1-butyl-3-chloro-4-(4-phenyl-1-piperidinyl)-(1H)-pyridone

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 23, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

UA (9); BU (5); RO (2); MO (1); RU (5); HU (4)