A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

Sponsors

Lead Sponsor: Janssen Research & Development, LLC

Source Janssen Research & Development, LLC
Brief Summary

The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression (TRD), as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Day 1 (prerandomization) to the end of the 4 week double-blind treatment phase (Day 28).

Overall Status Not yet recruiting
Start Date November 4, 2020
Completion Date June 30, 2022
Primary Completion Date March 31, 2022
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Day 1 (Pre-randomization) to the End of the 4-week Double-Blind Treatment Phase (Day 28) Baseline to Day 28
Secondary Outcome
Measure Time Frame
Change from Baseline in MADRS Total Score from Day 1 (Pre-randomization) to Day 2 Baseline to Day 2
Enrollment 450
Condition
Intervention

Intervention Type: Drug

Intervention Name: Esketamine 56 mg

Description: Esketamine 56 mg will be self administered as nasal spray.

Arm Group Label: Esketamine 56 Milligram (mg)

Other Name: JNJ-54135419

Intervention Type: Drug

Intervention Name: Esketamine 84 mg

Description: Esketamine 84 mg will be self administered as nasal spray.

Arm Group Label: Esketamine 84 mg

Other Name: JNJ-54135419

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching placebo will be self administered as nasal spray.

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria: - Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for single-episode MDD or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the MINI. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age - Participant must have had nonresponse (<=25% improvement) to >=2 oral antidepressant treatments in the current episode of depression, assessed using the MGH-ATRQ, and confirmed by documented records (example, medical/pharmacy/prescription records or a letter from a treating physician) - Participant must have an Inventory of Depressive Symptomatology-Clinician rated, 30-item (IDS-C30) total score of >=34 - The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the State vs. Trait, Assessibility, Face Validity, Ecological Validity, Rule of Three P's (SAFER) Interview - Participant must be medically stable on the basis of physical examination, medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed in the screening phase. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, the determination of their clinical significance must be determined by the investigator and recorded in the participant's source documents and initiated by the investigator - Participant must be medically stable on the basis of clinical laboratory tests performed in the screening phase. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator: (a) Participants with a pre-existing history of thyroid disease/disorder who are treated with thyroid hormones must be on a stable dosage for 3 months prior to the start of the screening phase; (b) For any participant (regardless of thyroid history), if the thyroid-stimulating hormone (TSH) value is out of range, a free thyroxine (FT4) will be conducted. If the FT4 value is abnormal and considered to be clinically significant (after discussion with the medical monitor), the participant is not eligible - Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided Exclusion Criteria: - The participant has used ketamine/esketamine (lifetime) - The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT - Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression - Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary) - Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Overall Contact

Last Name: Study Contact

Phone: 844-434-4210

Email: [email protected]

Location
Facility:
UAB Department of Psychiatry and Behavioral Neurobiology | Birmingham, Alabama, 35294, United States
Preferred Research Partners | Little Rock, Arkansas, 72211, United States
Behavioral Research Specialists, LLC | Glendale, California, 91206, United States
CalNeuro Research | Los Angeles, California, 90024, United States
Pacific Research Partners | Oakland, California, 94607, United States
Anderson Clinical Research | Redlands, California, 92374, United States
University of California at San Diego | San Diego, California, 92103-8620, United States
Artemis Institute for Clinical Research | San Diego, California, 92103, United States
University of California San Francisco | San Francisco, California, 94143, United States
CMB Clinical Trials | Santee, California, 92071, United States
University of Connecticut Health Center | Farmington, Connecticut, 06030-6415, United States
Hartford Hospital - Institute of Living | Hartford, Connecticut, 06106, United States
Yale University | New Haven, Connecticut, 06511, United States
MD Clinical | Hallandale Beach, Florida, 33009, United States
Florida Research Center Inc. | Miami, Florida, 33174, United States
APG Research, LLC | Orlando, Florida, 32803, United States
USF, Department of Psychiatry and Behavioral Neurosciences | Tampa, Florida, 33613, United States
Atlanta Behavioral Research, LLC | Atlanta, Georgia, 30338, United States
Psych Atlanta, P.C. | Marietta, Georgia, 30060, United States
Rush University Medical Center | Chicago, Illinois, 60612, United States
Chicago Research Center | Chicago, Illinois, 60634, United States
University of Chicago | Chicago, Illinois, 60637, United States
Joliet Center for Clinical Research | Joliet, Illinois, 60435, United States
Pillar Clinical Research, LLC | Lincolnwood, Illinois, 60712, United States
Loyola University Medical Center | Maywood, Illinois, 60153, United States
Psychiatric Medicine Associates LLC | Skokie, Illinois, 60076, United States
Neuroscience Research Institute | Winfield, Illinois, 60190, United States
University of Kansas School of Medicine | Wichita, Kansas, 67214, United States
Via Christi Hospitals Wichita, Inc | Wichita, Kansas, 67214, United States
Lake Charles Clinical Trials | Lake Charles, Louisiana, 70629, United States
Sheppard Pratt Health System | Baltimore, Maryland, 21204, United States
CBH Health | Gaithersburg, Maryland, 20877, United States
Adams Clinical Trials, LLC | Watertown, Massachusetts, 02472, United States
University of Massachusetts Medical School | Worcester, Massachusetts, 01655, United States
Rochester Center for Behavioral Medicine (RCBM) | Rochester Hills, Michigan, 48307, United States
Midwest Research Group - St. Charles Psychiatric Associates | Saint Charles, Missouri, 63304, United States
Washington University School of Medicine | Saint Louis, Missouri, 63110-6311, United States
Clinilabs | New York, New York, 10019, United States
The Medical Research Network, LLC | New York, New York, 10128, United States
Stony Brook University Medical Center | Stony Brook, New York, 11794, United States
Clinical Trials of America | Hickory, North Carolina, 28601, United States
Ohio State University | Columbus, Ohio, 43210, United States
Midwest Clinical Research Center | Dayton, Ohio, 45417, United States
Lindner Center of Hope | Mason, Ohio, 45040, United States
Paradigm Research Professionals, LLC | Oklahoma City, Oklahoma, 73118, United States
Lehigh Center for Clinical Research | Allentown, Pennsylvania, 18104, United States
University of Pennsylvania Medical Center | Philadelphia, Pennsylvania, 19104, United States
The Warren Alpert Medical School of Brown University - Butler Hospital | Providence, Rhode Island, 02906, United States
Medical University of South Carolina | Charleston, South Carolina, 29425, United States
BioBehavioral Research of Austin, PC | Austin, Texas, 78759, United States
Future Search Trials of Dallas | Dallas, Texas, 75231, United States
University of Texas Southwestern Medical Center | Dallas, Texas, 75235, United States
The University of Texas Health Science Center at Houston | Houston, Texas, 77021, United States
Brain Health Consultants and TMS Center | Houston, Texas, 77046, United States
Pillar Clinical Research, LLC | Richardson, Texas, 75080, United States
Family Psychiatry of The Woodlands | The Woodlands, Texas, 77381, United States
Grayline Research Center | Wichita Falls, Texas, 76309, United States
University of Virginia Center for Psychiatric Clinical Research | Charlottesville, Virginia, 22903, United States
Location Countries

United States

Verification Date

November 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Esketamine 56 Milligram (mg)

Type: Experimental

Description: Participants will receive nasal spray treatment with esketamine 56 mg twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 Montgomery-Asberg Depression Rating Scale [MADRS] assessment).

Label: Esketamine 84 mg

Type: Experimental

Description: Participants will receive nasal spray treatment with esketamine 84 mg twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 MADRS assessment).

Label: Placebo

Type: Experimental

Description: Participants will receive nasal spray treatment with placebo twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 MADRS assessment).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov