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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT01582815
• Date of registration: 20/04/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms
• Scientific title: A Multicenter, Double-Blind, Placebo-Controlled Study of JNJ-40411813 as Adjunctive Treatment to an Antidepressant in Adults With Major Depressive Disorder With Anxiety Symptoms
• Date of first enrolment: September 2012
• Target sample size: 121
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01582815
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Bulgaria, Hungary, Moldova, Republic of, Romania, Russian Federation, Slovakia, Ukraine

Contacts

• Name: Janssen Research & Development, LLC Clinical trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: JNJ-40411813

Drug: Placebo

Primary Outcome(s)

The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score [Time Frame: Baseline, Week 4]

Secondary Outcome(s)

The change from baseline to endpoint in the Clinical Global Impression - Improvement (CGI-I) scale [Time Frame: Baseline, Week 4]

The change from baseline to endpoint in the HAM-D6 score [Time Frame: Baseline, Week 4]

The change from baseline to endpoint on the Hamilton Depression Rating Scale (HDRS17) total score [Time Frame: Baseline, Week 4]

The number of patients at Week 4 with = 50% improvement on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score [Time Frame: Week 4]

The change from baseline to endpoint in the Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) anxiety subscale [Time Frame: Baseline, Week 4]

The change from baseline to endpoint in the Inventory of Depressive Symptomatolgy -Clinician rated (IDS-C30) total score [Time Frame: Baseline, Week 6]

The change from baseline to endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score [Time Frame: Baseline, Week 4]

The change from baseline to Week 4 in the Work Limitations Questionnaire (WLQ) [Time Frame: Baseline, Week 4]

The number and percentage of patients with either =50% or =30% improvement on the HDRS17 total score at Week 4, and number and percentage of patients with HDRS 17 total score = 7 at week 4 [Time Frame: Week 4]

The change from baseline to endpoint in the Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor total score [Time Frame: Baseline, Week 4]

The change from baseline to endpoint on the Medical Outcomes Study- 12-item Sleep Scale Acute - Revised (MOS Sleep-R) [Time Frame: Baseline, Week 4]

The change from baseline to endpoint in the Profile of Moods Scale-Brief Form (POMS-BF) [Time Frame: Baseline, Week 4]

The change from baseline to endpoint on the Perceived Stress Scale (PSS) [Time Frame: Baseline, Week 4]

The number of patients with a Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor score =7 at Week 4 [Time Frame: Week 4]

Secondary ID(s)

40411813DAX2001

CR100851

2011-006121-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors