The purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).

A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder

Depressive Disorder, Major

Major Depressive Disorder With Anxious Distress

Depressive Disorder

Depression

Mood disorders

Brain and Nervous System Conditions

Placebo

JNJ-89495120

A Randomized, Double-blind, Multicenter, Placebo-controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-89495120 as Monotherapy in Adult Participants With Major Depressive Disorder (MDD)

The MADRS is a clinician-administered 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.

The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Participant is assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Higher score indicating greater severity.

The SMDDS is a 16-item patient reported outcome (PRO) measure. Each item is rated by the participant according to a 5-point Likert scale, where 0 denotes "Not at all" or "Never" and 4 denotes "Extremely" or "Always". Before summing the items to create a total score, item 11 and item 12 are combined into a single score by selecting the highest severity on either item. The total score is then created by summing the responses on the 15 items, which range from 0 to 60. Higher score indicates more severe depressive symptomatology.

The GAD-7 scale is a self-administered questionnaire designed to measure anxiety. GAD-7 has seven items, which measure frequency of various signs of GAD using a 4-point Likert scale (where, Not at all = 0, Several days = 1, More than half the days = 2, and Nearly every day = 3). The total score ranges from 0 to 21 with increasing scores indicative of greater severity of symptoms of anxiety. Severity of anxiety on the GAD-7 is rated as follows: none (0-4), mild (5-9), moderate (10-14) and severe (15-21).

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Participants with abnormalities in vital signs (supine blood pressure, pulse/heart rate, respiratory rate, oral temperature) parameters will be reported.

Participants with 12-lead ECG abnormalities will be reported.

Participants with abnormalities in clinical laboratory parameters (hematology and serum chemistry) will be reported.

Participants with changes in weight/BMI will be reported.

The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.

The HVLT-R, a measure of verbal learning and memory, is a 12-item word list recall test. Administration includes 3 learning trials, a delayed recall (20-minute) trial, and a 24-word recognition list (including 12 target and 12 foil words). The test administrator reads instructions and word lists aloud, and records words recalled/recognized by the participant. Three learning trials are combined to calculate a total recall score learning, delayed recall, and recognition trials.

The DSST is recognized as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention. The DSST measures attention, working memory, sustained visual attention and psychomotor speed. Participants are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds.

Plasma concentrations of JNJ-89495120 will be reported.

Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study.

Participants will receive JNJ-89495120 dose A in Period 1 followed by JNJ-89495120 dose B in Period 2 during the DB treatment phase of the study.

Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study.

The purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant
effects) and how well it is tolerated as compared to placebo on reducing the symptoms of
depression in participants with major depressive disorder (MDD).

UAB Huntsville Regional Medical Campus

Chandler Clinical Trials

IMA Clinical Research PC

Noble Clinical Research

CI Trials

Wake Research PRI Encino

National Institute Of Clinical Research

WR-Newport Beach

ATP Clinical Research

Anderson Clinical Research

Artemis Institute for Clinical Research

Lumos Clinical Research Center LLC

Syrentis Clinical Research

Viking Clinical Research Ltd

Sunwise Clinical Research

Mountain View Clinical Research

Gulfcoast Medical Research Center

The Medici Medical Research

Advanced Research Institute of Miami

K2 Medical Research

Pharmax Research Clinic Inc

Wellness Research Center

Best Choice Medical and Research Service

Interventional Psychiatry of Tampa Bay

Synexus Clinical Research US Inc

iResearch Atlanta LLC

Indiana University IU Health

DelRicht Research

CBH Health

University of Massachusetts Medical School

Integrative Clinical Trials LLC

University of Cincinnati

OSU Department of Psychiatry and Behavioral Health

Paradigm Research Professionals, LLC

Coastal Carolina Research Center

Revival Research Institute LLC

Alpine Research Organization

Core Clinical Research

The MADRS is a clinician-administered 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.

The CGI-S provides an overall clinician-determined summary measure of the severity of the
participant's illness. The CGI-S evaluates the severity of psychopathology on a scale of
1 to 7. Participant is assessed on severity of illness at the time of rating according
to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill;
5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Higher score
indicating greater severity.

The SMDDS is a 16-item patient reported outcome (PRO) measure. Each item is rated by the
participant according to a 5-point Likert scale, where 0 denotes "Not at all" or "Never"
and 4 denotes "Extremely" or "Always". Before summing the items to create a total score,
item 11 and item 12 are combined into a single score by selecting the highest severity on
either item. The total score is then created by summing the responses on the 15 items,
which range from 0 to 60. Higher score indicates more severe depressive symptomatology.

The GAD-7 scale is a self-administered questionnaire designed to measure anxiety. GAD-7
has seven items, which measure frequency of various signs of GAD using a 4-point Likert
scale (where, Not at all = 0, Several days = 1, More than half the days = 2, and Nearly
every day = 3). The total score ranges from 0 to 21 with increasing scores indicative of
greater severity of symptoms of anxiety. Severity of anxiety on the GAD-7 is rated as
follows: none (0-4), mild (5-9), moderate (10-14) and severe (15-21).

An AE is any untoward medical occurrence in a clinical study participant administered a
pharmaceutical (investigational or non-investigational) product. An AE does not
necessarily have a causal relationship with the intervention.

Participants with abnormalities in vital signs (supine blood pressure, pulse/heart rate,
respiratory rate, oral temperature) parameters will be reported.

Participants with abnormalities in clinical laboratory parameters (hematology and serum
chemistry) will be reported.

The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts,
suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no'
items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation
with any methods (not plan) without intention to act, active suicidal ideation with some
intent to act without specific plan, active suicidal ideation with specific plan and
intent. Only items with yes responses are listed. Worsening of suicidal ideation was an
increase in severity of suicidal ideation from baseline.

The HVLT-R, a measure of verbal learning and memory, is a 12-item word list recall test.
Administration includes 3 learning trials, a delayed recall (20-minute) trial, and a
24-word recognition list (including 12 target and 12 foil words). The test administrator
reads instructions and word lists aloud, and records words recalled/recognized by the
participant. Three learning trials are combined to calculate a total recall score
learning, delayed recall, and recognition trials.

The DSST is recognized as covering all of the cognitive performance aspects: speed of
processing, executive functioning, and attention. The DSST measures attention, working
memory, sustained visual attention and psychomotor speed. Participants are given a table
that pairs digits and symbols, and asked to decipher a code using the table, completing
as many as possible in 90 seconds.

Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment
phase in Period 1 and Period 2 of the study.

Participants will receive JNJ-89495120 dose A in Period 1 followed by JNJ-89495120 dose B
in Period 2 during the DB treatment phase of the study.

Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase
in Period 1 and Period 2 of the study.

A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder

Trials at a glance

Trials at a glance

Eligibility criteria