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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04599855
Other study ID # CR108741
Secondary ID 54135419TRD4005
Status Completed
Phase Phase 4
First received
Last updated
Start date November 4, 2020
Est. completion date January 31, 2024

Study information

Verified date March 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 477
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Esketamine 56 mg
Esketamine 56 mg will be self administered as nasal spray.
Esketamine 84 mg
Esketamine 84 mg will be self administered as nasal spray.
Placebo
Matching placebo will be self administered as nasal spray.

Locations

Country Name City State
United States Lehigh Center for Clinical Research Allentown Pennsylvania
United States University of Michigan Ann Arbor Michigan
United States Atlanta Behavioral Research, LLC Atlanta Georgia
United States BioBehavioral Research of Austin PC Austin Texas
United States Sheppard Pratt Health System Baltimore Maryland
United States UAB Department of Psychiatry and Behavioral Neurobiology Birmingham Alabama
United States Copley Clinical Boston Massachusetts
United States University of Virginia Center for Psychiatric Clinical Research Charlottesville Virginia
United States Chicago Research Center Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Chicago Illinois
United States Ohio State University Columbus Ohio
United States Relaro Medical Trials Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Midwest Clinical Research Center Dayton Ohio
United States University of Connecticut Health Center Farmington Connecticut
United States CBH Health Gaithersburg Maryland
United States Behavioral Research Specialists LLC Glendale California
United States Velocity Clinical Research, Hallandale Beach Hallandale Beach Florida
United States Brain Health Consultants and TMS Center Houston Texas
United States The University of Texas Health Science Center at Houston Houston Texas
United States UAB Huntsville Regional Medical Campus Huntsville Alabama
United States Joliet Center for Clinical Research Joliet Illinois
United States Accel Research Sites Lakeland Florida
United States Pillar Clinical Research, LLC Lincolnwood Illinois
United States Preferred Research Partners Little Rock Arkansas
United States CalNeuro Research Los Angeles California
United States Psych Atlanta, P.C. Marietta Georgia
United States Clinilabs New York New York
United States The Medical Research Network, LLC New York New York
United States Pacific Research Partners Oakland California
United States Paradigm Research Professionals, LLC Oklahoma City Oklahoma
United States APG Research LLC Orlando Florida
United States University of Pennsylvania Medical Center Philadelphia Pennsylvania
United States The Warren Alpert Medical School of Brown University - Butler Hospital Providence Rhode Island
United States Anderson Clinical Research Redlands California
United States Pillar Clinical Research, LLC Richardson Texas
United States Rochester Center for Behavioral Medicine (RCBM) Rochester Hills Michigan
United States Midwest Research Group - St. Charles Psychiatric Associates Saint Charles Missouri
United States Artemis Institute for Clinical Research San Diego California
United States University of California at San Diego San Diego California
United States UCSF Nancy Friend Pritzker Psychiatry Building San Francisco California
United States Velocity Clinical Research Santa Ana California
United States CMB Clinical Trials Santee California
United States Psychiatric Medicine Associates LLC Skokie Illinois
United States Stony Brook University Medical Center Stony Brook New York
United States USF, Department of Psychiatry and Behavioral Neurosciences Tampa Florida
United States Family Psychiatry of The Woodlands The Woodlands Texas
United States Adams Clinical Watertown Massachusetts
United States Neuroscience Research Institute West Palm Beach Florida
United States Ascension via Christi Research Wichita Kansas
United States University of Kansas School of Medicine Wichita Kansas
United States Grayline Research Center Wichita Falls Texas
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. Baseline to Day 28
Secondary Change from Baseline in MADRS Total Score from Day 1 (Pre-randomization) to Day 2 MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. Baseline to Day 2
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