Back to resultsA Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-54175446, 600 mg
JNJ-54175446, 150 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) must be between 18 and 32 kilogram per square meter (kg/m^2) inclusive
- Related to symptoms of depression: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV or V diagnostic criteria for Major Depressive Disorder [MDD] (International Classification of Diseases (ICD)-code F32.x and F33.x), without psychotic features, as confirmed by the MINI 6.0; participant must have an IDS-C30 total score greater than or equal to (>=) 30 using the semi-structured interview guide for the IDS-C30
- Participant is, during this episode of depression, treatment naïve OR treated with at most one Selective serotonin reuptake inhibitor (SSRI) over a minimum of 6 weeks and a maximum of 6 months, and subject is being treated at an adequate dose, showing a partial response at enrolment
- A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test upon admission
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug
Exclusion Criteria:
- Has a primary DSM-IV or V diagnosis of general anxiety disorder (GAD), panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa. Participants with comorbid GAD, social anxiety disorder, or panic disorder for whom MDD is considered the primary diagnosis are not excluded
- Has a length of current major depressive episode greater than (>) 24 months despite adequate treatment
- Has failed more than 2 treatments with a different pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
- Participant has a history of substance use disorder according to DSM-V criteria, except nicotine or caffeine, within 6 months before Screening. However, participants who have completed a treatment for (alcohol) addiction more than 8 weeks prior to first dose administration and are under continuous control of the study center, may be included if the risk to fall back is considered minimal and no significant abnormalities are shown in clinical laboratory or other predose safety assessments
- Obstructive sleep apnea/hypopnea (apnea/hypopnea index >10) or restless legs syndrome (periodic leg movements with arousal index >15) as assessed on the first or second polysomnography (PSG) recording during screening
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group A: JNJ-54175446
Group B: Placebo + JNJ-54175446
Group C: Placebo
Arm Description
Participants will receive a loading dose of JNJ-54175446, 600 milligram (mg) on Day 1 followed by JNJ-54175446, 150 mg once daily until Day 10.
Participants will receive placebo on Days 1 to 3 followed by a loading dose of JNJ-54175446, 600 mg on Day 4 followed by JNJ-54175446, 150 mg once daily until Day 10.
Participants will receive placebo from Day 1 until Day 10.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by HDRS17/IDS-C30 Rating Scale
Hamilton Depression Rating Scale 17 (HDRS17) contains 17 items pertaining to symptoms of depression experienced over the past week. Score range is from 0 to 52. The Inventory of Depressive Symptomatology- Clinician rated-30 (IDS-C30) is a standardized 30 item, clinician rated, scale to assess the severity of a participant's depressive symptoms. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression.
Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by QIDS-SR16/QIDS-SR10 Rating Scale
The QIDS-SR16 (1 week recall period) is a participant reported measure designed to assess the severity of depressive symptoms. The total score ranges from 0 to 27 (none 1-5, mild 6-10, moderate 11-15, severe 16-20 and very severe 21-27). QIDS-SR10 is a version of the QIDS-SR16 with a shorter, 2-hour recall period and 10-item measure. Scoring for each domain will be the same as for the QIDS-SR16.
Effect of JNJ-54175446 Versus Placebo on TSD-Induced Changes in Biomarker Profiles (interleukin [IL]-1 beta, cortisol)
Effect of JNJ-54175446 Versus Placebo on Latency to Persistent Sleep (LPS)
Latency to persistent sleep is defined as the length of time from full wakefulness to the first sleep stage.
Effect of JNJ-54175446 Versus Placebo on Total Sleep Time (TST)
All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.
Effect of JNJ-54175446 Versus Placebo on Wake After Sleep Onset (WASO)
The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.
Effect of JNJ-54175446 Versus Placebo on Sleep Efficiency (SE)
The total sleep time divided by the total time in bed (that is, the number of minutes from the beginning of the Polysomnography recording to the end of the recording).
Effect of JNJ-54175446 Versus Placebo on Snaith-Hamilton Pleasure Scale [SHAPS])
The SHAPS is a short, 14-item instrument to measure anhedonia, which has been shown to be valid and reliable in normal and clinical samples. Each of the 14 items has a set of four response categories: Definitely Agree (= 1), Agree (= 2), Disagree (= 3), and Definitely Disagree (= 4). A higher total score indicates higher levels of state anhedonia.
Effect of JNJ-54175446 Versus Placebo on Profile of Mood States brief form (POMS)
The POMS measures individuals' mood states. The POMS consists of 30 positive and negative mood descriptors. Participants are asked to rate, on a 5-point scale from 0 (not at all) to 4 (extremely), the extent to which they experience each mood state during at a specific moment.
Effect of JNJ-54175446 Versus Placebo on Emotional Faces Recognition Test
Evaluation of positive and negative effect using emotional faces recognition test. The participant is seated at a computer screen and instructed to remember 42 images shown during a training session. Subject then identifies those images during a testing session in which the 42 probe images are interspersed among 42 additional foil images. Implicit recognition is detected by EEG.
Effect of JNJ-54175446 Versus Placebo on Soluble Biomarkers (Inclusive Ex-vivo Lipopolysaccharide [LPS]/Benzoylated(Bz) Adenosine Triphosphate [ATP]-Induced IL-1 Beta Release)
Effect of JNJ-54175446 Versus Placebo on Central Pharmacodynamic (PD) by Motor Learning by Adaptive Tracking Test
Performance will be scored after a fixed period of 3.5 minutes and reflected visuo motor control and vigilance. The average performance scores will be used in the analysis.
Effect of JNJ-54175446 Versus Placebo on Sustained Attention by the Three Choice Vigilance Task (3CVT) With EEG
An implicit image recognition (IR) task combined with emotional elicitation evaluates attention, encoding and image recognition memory during implicit emotion elicitation.
Maximum Observed Plasma Concentration (Cmax) of JNJ-54175446
The Cmax is the maximum observed plasma concentration.
Minimum Observed Plasma Concentration (Cmin) of JNJ-54175446
Minimum observed plasma concentration during dosing interval (tau).
Trough Plasma Concentration (Ctrough) of JNJ-54175446
The observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Average Plasma Concentration at Steady State (Cavg) of JNJ-54175446
Average plasma concentration at steady state over the dosing interval.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-54175446
Area Under the Plasma ConcentrationTime Curve During a Dosing Interval (tau) [AUCtau] of JNJ-54175446
Area Under the Plasma ConcentrationTime Curve From Time Zero to Time 't' (AUC[0t]) of JNJ-54175446
Apparent Elimination HalfLife (t1/2) of JNJ-54175446
Apparent elimination half-life associated with the terminal slope (Lambda[z]) of the semilogarithmic drug concentration time curve, after multiple-dose administration only.
Ratio of the Maximum Plasma Concentration (Peak) to Trough Observed Concentration of JNJ-54175446
The ratio of the maximum plasma concentration (Peak) to trough observed concentration.
Accumulation Ratio Based on AUC of JNJ-54175446
Accumulation ratio based on AUC, determined after multiple-dose administration and calculated as AUCtau on Day 1 divided by AUCtau on Day 10.
Effect of JNJ-54175446 Versus Placebo on a Reward Test
The reward task was a probabilistic instrumental learning task involving monetary wins or losses. In order to maximize payoffs, participants should use the outcome feedback to gradually learn the symbol-outcome associations by trial and error over time, such that they consistently choose the symbol with the high-probability win and avoid the symbol with the high-probability loss. Outcome measures included overall total, total won and lost, choice frequency, percentage of choices identical to the preceding one (percentage consistency), reaction time and re-reaction time.
Full Information
NCT ID
NCT02902601
First Posted
September 13, 2016
Last Updated
May 18, 2022
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02902601
Brief Title
A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Subjects With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2016 (Actual)
Primary Completion Date
June 2, 2017 (Actual)
Study Completion Date
June 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the safety and tolerability of JNJ 54175446 in participants with Major Depressive Disorder (MDD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: JNJ-54175446
Arm Type
Experimental
Arm Description
Participants will receive a loading dose of JNJ-54175446, 600 milligram (mg) on Day 1 followed by JNJ-54175446, 150 mg once daily until Day 10.
Arm Title
Group B: Placebo + JNJ-54175446
Arm Type
Experimental
Arm Description
Participants will receive placebo on Days 1 to 3 followed by a loading dose of JNJ-54175446, 600 mg on Day 4 followed by JNJ-54175446, 150 mg once daily until Day 10.
Arm Title
Group C: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo from Day 1 until Day 10.
Intervention Type
Drug
Intervention Name(s)
JNJ-54175446, 600 mg
Intervention Description
Participants will receive JNJ-54175446, 600 mg as an oral suspension.
Intervention Type
Drug
Intervention Name(s)
JNJ-54175446, 150 mg
Intervention Description
Participants will receive JNJ-54175446, 150 mg as an oral suspension.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to JNJ-54175446
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame
Up to Day 17
Secondary Outcome Measure Information:
Title
Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by HDRS17/IDS-C30 Rating Scale
Description
Hamilton Depression Rating Scale 17 (HDRS17) contains 17 items pertaining to symptoms of depression experienced over the past week. Score range is from 0 to 52. The Inventory of Depressive Symptomatology- Clinician rated-30 (IDS-C30) is a standardized 30 item, clinician rated, scale to assess the severity of a participant's depressive symptoms. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression.
Time Frame
Baseline, Day 4 and 10: 2 to 8 hours post dose, Day 17
Title
Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by QIDS-SR16/QIDS-SR10 Rating Scale
Description
The QIDS-SR16 (1 week recall period) is a participant reported measure designed to assess the severity of depressive symptoms. The total score ranges from 0 to 27 (none 1-5, mild 6-10, moderate 11-15, severe 16-20 and very severe 21-27). QIDS-SR10 is a version of the QIDS-SR16 with a shorter, 2-hour recall period and 10-item measure. Scoring for each domain will be the same as for the QIDS-SR16.
Time Frame
Baseline, Day 3 and 10: 2 to 8 hours post dose, Day 17
Title
Effect of JNJ-54175446 Versus Placebo on TSD-Induced Changes in Biomarker Profiles (interleukin [IL]-1 beta, cortisol)
Time Frame
Day 1 and 4: Predose, 2, 8 hours postdose, Day 10: Predose
Title
Effect of JNJ-54175446 Versus Placebo on Latency to Persistent Sleep (LPS)
Description
Latency to persistent sleep is defined as the length of time from full wakefulness to the first sleep stage.
Time Frame
Baseline, Day 2 to 3 and Day 4 to 5
Title
Effect of JNJ-54175446 Versus Placebo on Total Sleep Time (TST)
Description
All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.
Time Frame
Baseline, Day 2 to 3 and Day 4 to 5
Title
Effect of JNJ-54175446 Versus Placebo on Wake After Sleep Onset (WASO)
Description
The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.
Time Frame
Baseline, Day 2 to 3 and Day 4 to 5
Title
Effect of JNJ-54175446 Versus Placebo on Sleep Efficiency (SE)
Description
The total sleep time divided by the total time in bed (that is, the number of minutes from the beginning of the Polysomnography recording to the end of the recording).
Time Frame
Baseline, Day 2 to 3 and Day 4 to 5
Title
Effect of JNJ-54175446 Versus Placebo on Snaith-Hamilton Pleasure Scale [SHAPS])
Description
The SHAPS is a short, 14-item instrument to measure anhedonia, which has been shown to be valid and reliable in normal and clinical samples. Each of the 14 items has a set of four response categories: Definitely Agree (= 1), Agree (= 2), Disagree (= 3), and Definitely Disagree (= 4). A higher total score indicates higher levels of state anhedonia.
Time Frame
Baseline, Day 3, 4, 5 and 10: 2 to 8 hours postdose
Title
Effect of JNJ-54175446 Versus Placebo on Profile of Mood States brief form (POMS)
Description
The POMS measures individuals' mood states. The POMS consists of 30 positive and negative mood descriptors. Participants are asked to rate, on a 5-point scale from 0 (not at all) to 4 (extremely), the extent to which they experience each mood state during at a specific moment.
Time Frame
Baseline, Day 3, 10: 2 to 8 hours postdose, Day 4, 5: 2 to 8 and 19 hours postdose
Title
Effect of JNJ-54175446 Versus Placebo on Emotional Faces Recognition Test
Description
Evaluation of positive and negative effect using emotional faces recognition test. The participant is seated at a computer screen and instructed to remember 42 images shown during a training session. Subject then identifies those images during a testing session in which the 42 probe images are interspersed among 42 additional foil images. Implicit recognition is detected by EEG.
Time Frame
Baseline, Day 4 and 10: 2 to 8 hours postdose
Title
Effect of JNJ-54175446 Versus Placebo on Soluble Biomarkers (Inclusive Ex-vivo Lipopolysaccharide [LPS]/Benzoylated(Bz) Adenosine Triphosphate [ATP]-Induced IL-1 Beta Release)
Time Frame
Day 1 and 4: Predose, 2, 8 hours postdose, Day 10: Predose
Title
Effect of JNJ-54175446 Versus Placebo on Central Pharmacodynamic (PD) by Motor Learning by Adaptive Tracking Test
Description
Performance will be scored after a fixed period of 3.5 minutes and reflected visuo motor control and vigilance. The average performance scores will be used in the analysis.
Time Frame
Baseline, Day 10: Predose, 1, 2, 4 and 6 hour post dose
Title
Effect of JNJ-54175446 Versus Placebo on Sustained Attention by the Three Choice Vigilance Task (3CVT) With EEG
Description
An implicit image recognition (IR) task combined with emotional elicitation evaluates attention, encoding and image recognition memory during implicit emotion elicitation.
Time Frame
Baseline, Day 3, 4, 5 and 10: 2 to 8 hours postdose
Title
Maximum Observed Plasma Concentration (Cmax) of JNJ-54175446
Description
The Cmax is the maximum observed plasma concentration.
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Minimum Observed Plasma Concentration (Cmin) of JNJ-54175446
Description
Minimum observed plasma concentration during dosing interval (tau).
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Trough Plasma Concentration (Ctrough) of JNJ-54175446
Description
The observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Average Plasma Concentration at Steady State (Cavg) of JNJ-54175446
Description
Average plasma concentration at steady state over the dosing interval.
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-54175446
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Area Under the Plasma ConcentrationTime Curve During a Dosing Interval (tau) [AUCtau] of JNJ-54175446
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Area Under the Plasma ConcentrationTime Curve From Time Zero to Time 't' (AUC[0t]) of JNJ-54175446
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Apparent Elimination HalfLife (t1/2) of JNJ-54175446
Description
Apparent elimination half-life associated with the terminal slope (Lambda[z]) of the semilogarithmic drug concentration time curve, after multiple-dose administration only.
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Ratio of the Maximum Plasma Concentration (Peak) to Trough Observed Concentration of JNJ-54175446
Description
The ratio of the maximum plasma concentration (Peak) to trough observed concentration.
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Accumulation Ratio Based on AUC of JNJ-54175446
Description
Accumulation ratio based on AUC, determined after multiple-dose administration and calculated as AUCtau on Day 1 divided by AUCtau on Day 10.
Time Frame
Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17
Title
Effect of JNJ-54175446 Versus Placebo on a Reward Test
Description
The reward task was a probabilistic instrumental learning task involving monetary wins or losses. In order to maximize payoffs, participants should use the outcome feedback to gradually learn the symbol-outcome associations by trial and error over time, such that they consistently choose the symbol with the high-probability win and avoid the symbol with the high-probability loss. Outcome measures included overall total, total won and lost, choice frequency, percentage of choices identical to the preceding one (percentage consistency), reaction time and re-reaction time.
Time Frame
Baseline, Day 3, 4, 5 and 10: 2 to 8 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) must be between 18 and 32 kilogram per square meter (kg/m^2) inclusive
Related to symptoms of depression: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV or V diagnostic criteria for Major Depressive Disorder [MDD] (International Classification of Diseases (ICD)-code F32.x and F33.x), without psychotic features, as confirmed by the MINI 6.0; participant must have an IDS-C30 total score greater than or equal to (>=) 30 using the semi-structured interview guide for the IDS-C30
Participant is, during this episode of depression, treatment naïve OR treated with at most one Selective serotonin reuptake inhibitor (SSRI) over a minimum of 6 weeks and a maximum of 6 months, and subject is being treated at an adequate dose, showing a partial response at enrolment
A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test upon admission
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug
Exclusion Criteria:
Has a primary DSM-IV or V diagnosis of general anxiety disorder (GAD), panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa. Participants with comorbid GAD, social anxiety disorder, or panic disorder for whom MDD is considered the primary diagnosis are not excluded
Has a length of current major depressive episode greater than (>) 24 months despite adequate treatment
Has failed more than 2 treatments with a different pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
Participant has a history of substance use disorder according to DSM-V criteria, except nicotine or caffeine, within 6 months before Screening. However, participants who have completed a treatment for (alcohol) addiction more than 8 weeks prior to first dose administration and are under continuous control of the study center, may be included if the risk to fall back is considered minimal and no significant abnormalities are shown in clinical laboratory or other predose safety assessments
Obstructive sleep apnea/hypopnea (apnea/hypopnea index >10) or restless legs syndrome (periodic leg movements with arousal index >15) as assessed on the first or second polysomnography (PSG) recording during screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Schwerin
Country
Germany
City
Leiden
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder
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