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An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02473289
Recruitment Status : Completed
First Posted : June 16, 2015
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50 milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week double-blind treatment period) is compared to adjunctive placebo based on the change from baseline to 12-week endpoint in depressive symptoms as measured by the total score on the Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) >=0.300 milligram per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects with hsCRP <0.300 milligram per deciliter will also be enrolled to allow a better understanding of the relationship between CRP and clinical changes.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Sirukumab 50 mg Drug: Placebo Phase 2

Detailed Description:
A double-blind, placebo-controlled, multicenter study of sirukumab as adjunctive treatment to a monoaminergic antidepressant in adults with major depressive disorder. Participants will be randomly assigned to receive either placebo or sirukumab 50 milligram (mg) at a ratio of 1:1 at Day 1, 28 and 56. Participants will primarily be assessed for change from baseline in Hamilton Depression Rating Scale (HDRS17) score at Week 12. Safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multicenter Study of Sirukumab as Adjunctive Treatment to a Monoaminergic Antidepressant in Adults With Major Depressive Disorder
Actual Study Start Date : July 23, 2015
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : May 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sirukumab 50 milligram (mg)
Participants will receive sirukumab 50 mg as subcutaneous injection on Day 1, 28 and 56.
Drug: Sirukumab 50 mg
Participants will receive sirukumab 50 mg as subcutaneous injection on Day 1, 28 and 56.

Placebo Comparator: Placebo
Participants will receive matching placebo on Day 1, 28 and 56.
Drug: Placebo
Participants will receive matching placebo on Day 1, 28 and 56.




Primary Outcome Measures :
  1. Change From Baseline in Hamilton Depression Rating Scale (HDRS-17) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.


Secondary Outcome Measures :
  1. Change From Baseline in HDRS-17 Total Score at Weeks 1, 4 and 8 [ Time Frame: Baseline, Weeks 1, 4 and 8 ]
    The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition.

  2. Percentage of Participants With Remission as Assessed by HDRS-17 Total Score at Week 12 [ Time Frame: Week 12 ]
    Remission- Percentage of participants with HDRS-17 total score less than or equal to (<=) 7 were considered as remitters. HDRS-17 defined as clinician-administered rating scale designed to assess severity of symptoms in participants diagnosed with depression with score range of 0 to 52. Each of 17 items is rated by clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, a higher score represents a more severe condition.

  3. Percentage of Participants With Response as Assessed by HDRS-17 Total Score at Week 12 [ Time Frame: Week 12 ]
    Response- Percentage of participants with greater than or equal to (>=) 50 percent (%) improvement on the HDRS-17 total score from baseline at Week 12 were considered as responders. The HDRS-17 defined as clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition.

  4. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22 [ Time Frame: Baseline and Weeks 1, 4, 8, 12, 16, and 22 ]
    CGI-S defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition.

  5. Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22 [ Time Frame: Baseline and Weeks 1, 4, 8, 12, 16, and 22 ]
    The PHQ-9 used as a participant-reported measure of depressive symptomatology. The PHQ-9 is 9-item scale, where each item is rated on a 4-point scale (0=Not at all, 1=Several Days, 2=More than half the days, and 3=Nearly every day). The participant's item responses were summed to provide a total score range of 0 to 27. Higher scores indicates greater severity of depressive symptoms. The recall period is 2 weeks.

  6. Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22 [ Time Frame: Baseline and Weeks 1, 4, 8, 12, 16, and 22 ]
    The Snaith-Hamilton Pleasure Scale (SHAPS) is short, 14-item instrument to measure anhedonia. Each of the 14 items has a set of four response categories (Definition 1): Definitely Agree (=1), Agree (= 2), Disagree (= 3), and Definitely Disagree (= 4). A SHAPS total score was calculated as the sum of the 14 item scores with a total score range from 14 to 56. A higher total score indicates higher levels of state anhedonia.

  7. Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22 [ Time Frame: Baseline and Weeks 1, 4, 8, 12, 16, and 22 ]
    The Snaith-Hamilton Pleasure Scale (SHAPS) is short, 14-item instrument to measure anhedonia. Each of the 14 items has a set of four response categories (Definition 2): Definitely Agree (= 0), Agree (= 0), Disagree (= 1), and Definitely Disagree (= 1). A SHAPS total score was calculated as the sum of the 14 item scores with a score range from 0 to 14. A higher total score indicates higher levels of state anhedonia.

  8. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22 [ Time Frame: Baseline and Weeks 1, 4, 8, 12, 16, and 22 ]
    The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score] for all except for 2 items: "I have energy" and "I am able to do my usual activities"), and ranges from 0 to 52, with a higher score indicating less fatigue.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have a primary DSM-5 diagnosis of MDD
  • Must have a HDRS total score greater than or equal to (>=) 18 at screening and predose at Day 1, as recorded by the remote independent rater and must not demonstrate an improvement of > 25 percent (%) on their HDRS total score from the screening to baseline visit
  • Must be medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests and 12-lead ECG performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator
  • Participants with hypothyroidism who are on stable treatment for 3 months prior to screening are required to have thyroid stimulating hormone (TSH) and free thyroxine (FT4) obtained. If the TSH value is out of range, but FT4 is normal, such cases should be discussed directly with the medical monitor before the subject is enrolled. If the FT4 value is out of range, the participant is not eligible

Exclusion Criteria:

  • Any other current Axis one psychiatric condition, including, but not limited to, MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (eg, bulimia, anorexia nervosa), or schizophrenia (lifetime). The MINI will be used to screen for comorbid psychiatric diagnoses. As noted above, subjects with a diagnosis of comorbid GAD, Post-Traumatic Stress Disorder, Persistent Depressive Disorder, ADHD, Social Anxiety Disorder, Panic Disorder with or without agoraphobia or Nicotine/Caffeine Dependence may be included, if the investigator considers MDD to be the primary diagnosis
  • A history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
  • A current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the C-SSRS at screening or baseline. Subjects with a prior suicide attempt of any sort, or history of prior serious suicidal ideation/plan should be carefully screened for current suicidal ideation and only included at the discretion of the investigator
  • More than 3 failed antidepressant treatments (of adequate dose and duration) in the current episode of depression (verified by the MGH-ATRQ)
  • Length of current major depressive episode > 60 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473289


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Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Bellflower, California, United States
Glendale, California, United States
Lemon Grove, California, United States
Orange, California, United States
Santa Ana, California, United States
Torrance, California, United States
Wildomar, California, United States
United States, Georgia
Atlanta, Georgia, United States
Decatur, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Edgewood, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Grand Rapids, Michigan, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New York
Brooklyn, New York, United States
New York, New York, United States
Staten Island, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Texas
Houston, Texas, United States
Plano, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Canada, Alberta
Edmonton, Alberta, Canada
Canada, Ontario
Chatham, Ontario, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Poland
Belchatow, Poland
Bydgoszcz, Poland
Chelmno, Poland
Gorlice, Poland
Lublin, Poland
Russian Federation
Karelia, Russian Federation
Moscow, Russian Federation
Nizny Novgorod, Russian Federation
Rostov-on-Don, Russian Federation
Saratov Region, Russian Federation
Saratov, Russian Federation
St-Petersburg, Russian Federation
Tomsk, Russian Federation
Yaroslavl, Russian Federation
United Kingdom
Edinburgh, United Kingdom
Glasgow, United Kingdom
Oxford, United Kingdom
Redruth, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] January 22, 2018
Statistical Analysis Plan  [PDF] December 3, 2018


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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02473289     History of Changes
Other Study ID Numbers: CR107171
CNTO136MDD2001 ( Other Identifier: Janssen Research & Development, LLC )
2014-005206-37 ( EudraCT Number )
First Posted: June 16, 2015    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Depressive disorder, major
Sirukumab
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs