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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01582815
First received: April 20, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: JNJ-40411813
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The change from baseline to endpoint on the Hamilton Depression Rating Scale (HDRS17) total score [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

  • 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 ] [ Designated as safety issue: No ]
    The (HAM-A) is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom.

  • The change from baseline to endpoint in the Clinical Global Impression - Improvement (CGI-I) scale [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

  • The change from baseline to endpoint in the Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor total score [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

  • The change from baseline to endpoint in the HAM-D6 score [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The HAM-D6 is a 6-item subscale derived from the Hamilton Depression Rating Scale (HDRS17). The rating scale measures the severity of depressive symptomatology. Higher scores represent more severe depressive symptoms.

  • The change from baseline to endpoint in the Inventory of Depressive Symptomatolgy -Clinician rated (IDS-C30) total score [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    The IDS-C30 is a clinician administered 30 item depression specific severity rating scale designed to measure specific signs and symptoms of depression including melancholic, atypical and anxious features. Scores range from 0 to 84 with higher scores representing greater severity of depressive symptoms.

  • The change from baseline to endpoint in the Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) anxiety subscale [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The IDS-C30 is a clinician administered 30 item depression specific severity rating scale designed to measure specific signs and symptoms of depression including melancholic, atypical and anxious features. The anxiety subscale includes five anxiety symptoms: anxious mood, somatic complaints, sympathetic arousal, panic, and gastrointestinal symptoms. The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms.

  • The change from baseline to Week 4 in the Work Limitations Questionnaire (WLQ) [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The WLQ is a 25-item questionnaire self-report rating scale developed to measure the on-the-job impact of chronic health problems and/or treatment ("work limitations"), with a recall period of the previous 2 weeks. It comprises four dimensions of limitations: handling time, physical, mental-interpersonal, and output demands. Patients respond to each item with options ranging from "Almost all of the time" to "none of the time", or "Does not apply to my job". The global score ranges from 0 to 100 with lower score indicating low level of work limitations.

  • The change from baseline to endpoint on the Perceived Stress Scale (PSS) [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The PSS is a 10-item, self-reported unidimensional instrument developed to measure perceived stress in response to situations in a person's life. Prevalence of an item within the last month is measured on a 5 point scale, ranging from "never" to "very often". Higher scores reflect higher levels of perceived stress.

  • The change from baseline to endpoint in the Profile of Moods Scale-Brief Form (POMS-BF) [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The POMS-BF is a 30 item, self-report inventory in which a series of mood states (such as "Tense" or "Worn out") are rated based on how well each item describes the respondent's mood during the past week, including today. Items are rated on a 5-point scale with response options of: "Not at all", "A little", "Moderately", "Quite a bit" or "Extremely" with a global score range of 0 to 120 or individual domain scores on Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Lower scores indicate better mood state.

  • 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 ] [ Designated as safety issue: No ]
    The MOS Sleep-R is a self-reported scale containing 12 items addressing dimensions of sleep. It comprises six subscales: sleep disturbance, snoring, shortness of breath or headache, sleep adequacy, sleep somnolence, and sleep quantity. Items are answered on 5-point scales, where 1="all of the time," and 5="none of the time," 1 item (sleep latency) is answered on a 5 point scale from 1="0-15 minutes" to 5="more than 60 minutes." Score range of 0 to 100, where higher scores indicate fewer sleep-related problems. Duration of sleep is scored as the average number of hours slept per night.

  • The number of patients with a Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor score ≥7 at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

  • 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 ] [ Designated as safety issue: No ]
    The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

  • 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 ] [ Designated as safety issue: No ]
    The (HAM-A) is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom.


Enrollment: 121
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JNJ-40411813 Drug: 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.
Placebo Comparator: Placebo Drug: Placebo
Form= capsule, route= oral administration. Matching placebo will be administered twice daily during 8 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582815

Locations
Bulgaria
Bourgas, Bulgaria
Kazanlak, Bulgaria
Rousse, Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Hungary
Baja, Hungary
Budapest, Hungary
Gyõr, Hungary
Kalocsa, Hungary
Moldova, Republic of
Chisinau, Moldova, Republic of
Romania
Arad, Romania
Iasi, Romania
Russian Federation
Nizny Novgorod, Russian Federation
Saratov, Russian Federation
St Petersburg, Russian Federation
St-Peterburg, Russian Federation
St-Petersburg, Russian Federation
Tomsk, Russian Federation
Ukraine
Donetsk, Ukraine
Glevakha, Ukraine
Kharkiv, Ukraine
Kiev, Ukraine
Lviv, Ukraine
Odessa, Ukraine
Smela, Ukraine
Uzhgorod, Ukraine
Village Stepanovka Kherson, Ukraine
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01582815     History of Changes
Other Study ID Numbers: CR100851, 40411813DAX2001, 2011-006121-26
Study First Received: April 20, 2012
Last Updated: January 15, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Russia: Russian Drug Agency
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines

Keywords provided by Janssen Research & Development, LLC:
Major Depressive Disorder
Depression
Anxiety symptoms
JNJ-40411813

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
Mental Disorders
Mood Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014