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A Study of JNJ-61393215 in the Treatment of Depression

Primary Purpose

Major Depressive Disorder With Anxious Distress

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

JNJ-61393215

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder With Anxious Distress

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m^2)
Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress, as assessed by the mini international neuropsychiatric inventory 7.0. Plus (MINI). Participants with a diagnosis of comorbid generalized anxiety disorder (GAD), post-traumatic stress disorder, persistent depressive disorder, attention deficit hyperactivity disorder (ADHD), social anxiety disorder or nicotine/caffeine dependence may be included, if MDD is primary diagnosis
Participants must have an inventory of depressive symptomatology, clinician rating-30 (IDS-C30) total score greater than or equal to (>=) 35 (moderate to severe depression)
Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the massachusetts general hospital antidepressant treatment history questionnaire (MGH-ATRQ)
Participant must be currently receiving 1 of the following antidepressants for at least 6 weeks duration at screening, at an adequate therapeutic dose, as determined by the MGH-ATRQ and should remain on a stable dose throughout the study: bupropion, citalopram, escitalopram, sertraline, paroxetine, venlafaxine, desvenlafaxine, duloxetine, fluoxetine, vilazodone, vortioxetine, mirtazapine, agomelatine, nortriptyline, imipramine, amitriptyline and levomilnacipran
Participants must have a suboptimal response (improvement <50%) to the antidepressant used as their current treatment, as measured by the MGH-ATRQ
A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose

Exclusion Criteria:

Participant has any other 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 (example: bulimia, anorexia nervosa), or schizophrenia (lifetime)
Age of onset of depression is after 55 years of age
Participant has a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
Participant has 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 Colombia suicide severity rating scale (C-SSRS) at screening or baseline
Length of current major depressive episode >60 months
Participant has organic brain disease or dementia or has known or suspected intellectual development disorder
Participant has been treated with at least one of the following treatments: (a) electroconvulsive therapy in the current episode; (b) deep brain stimulation (lifetime); (c) repetitive transcranial magnetic stimulation within 4 weeks prior to baseline visit
Participant has any clinically relevant medical condition that could potentially alter the absorption, metabolism, or excretion of the study intervention, such as liver disease or renal disease
Participant has a relevant history of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures - uncomplicated childhood febrile seizures with no sequelae are not exclusionary) or significant cerebrovascular, renal, hepatic, dermatologic, hematologic, gastrointestinal or endocrine diseases. Hospitalization for cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack) within 3 months prior to the first administration of study drug is exclusionary. Diabetes mellitus be allowed when the participant is stable (HbA1c less than 7.5% or 58 mmol/mol)
Participant has a clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening or baseline Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable.If at screening visit QTcB or QTcF interval >=450 ms for males or >=470 ms for females, or >480 ms if bundle branch block and prolongation of the QTc interval are present;participant is excluded
Participant has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis

Sites / Locations

Collaborative NeuroScience Network
Atlanta Institute
Atlanta Center for Medical Research
The Medical Research Network, LLC
Richmond Behavioural Associates
Ohio State University
IPS Research Company
Suburban Research Associates
UT Southwestern Medical Center
ARENSIA
City Clinical Psychiatric Hopsital 3
Nizny Novgorod clinical psychiatric hospital 1
Orenburg Regional Clinical Psychiatric Hospital #1
Medical and Rehabilitation Research Center Phoenix
Engels psychiatric hospital
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
Saratov Regional Psychiatric hospital named after St. Sofia
Psychoneurological dispensary 10
City Psychiatric hospital 7 named after I.P.Pavlov
Psychoneurological dispensary 1
Psychoneurological Dispensary #4
Stavropol Region Psychiatric Hospital #2
Research Institute of Mental Health
MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
Kyiv Railway Station Clinical Hospital #2
Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'
MAC Clinical Research
MAC Clinical Research
Kings College London
MAC Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JNJ-61393215 135 milligram (mg)

Placebo

Arm Description

Participants will receive JNJ-61393215 135 mg (3*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.

Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.

Outcomes

Primary Outcome Measures

Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6

Change from baseline in HDRS-17 total score at Week 6 was reported. 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 (range: 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 (greater depression).

Secondary Outcome Measures

Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6

Change from baseline in HAM-A total score at Week 6 was reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.

Change From Baseline in HAM-A Total Score at Weeks 2 and 4

Change from baseline in HAM-A total score at Weeks 2 and 4 were reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.

Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6

Change from baseline in HDRS-17 total score in participants with a baseline HAM-A score >=20 at Week 6 was reported. 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 (range: 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 (greater depression).

Change From Baseline in HAM-A Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6

Change from baseline in HAM-A total score in participants with a baseline HAM-A score >=20 at Week 6 was reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.

Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6

Change from baseline in GAD-7 total score at Week 6 was reported. The GAD-7 is a brief and validated 7-item self-reported assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15-21).

Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2 and 4

Change From baseline in PHQ-9 total score at Weeks 2 and 4. The PHQ-9 is a 9-item, Patient Reported Outcome (PRO) measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) major depressive disorder (MDD) criteria. 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 participants item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).

Change From Baseline in HDRS-17 Total Score at Weeks 2 and 4

Change From baseline in HDRS-17 total score at Weeks 2 and 4. 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 (range: 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 (greater depression).

Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events during the initiation of study drug up till follow-up period.

Total Plasma Concentration of JNJ-61393215

Total plasma concentration of JNJ-61393215 was reported. The concentrations of JNJ-61393215 were measured using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.

Plasma Protein Binding (PPB): Percentage of JNJ-61393215 Unbound

Percentage of JNJ-61393215 unbound was determined by using a liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method. The protein binding was assessed by spiking plasma samples with radiolabeled JNJ-61393215.

Full Information

NCT ID

NCT04080752

First Posted

September 4, 2019

Last Updated

June 30, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04080752

Brief Title

A Study of JNJ-61393215 in the Treatment of Depression

Official Title

Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 17, 2019 (Actual)

Primary Completion Date

September 2, 2021 (Actual)

Study Completion Date

September 2, 2021 (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 Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder With Anxious Distress

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JNJ-61393215 135 milligram (mg)

Arm Type

Experimental

Arm Description

Participants will receive JNJ-61393215 135 mg (3*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.

Intervention Type

Drug

Intervention Name(s)

JNJ-61393215

Other Intervention Name(s)

Orexin-1

Intervention Description

JNJ-61393215 will be administrated orally.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo will be administered orally.

Primary Outcome Measure Information:

Title

Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6

Description

Time Frame

Baseline and Week 6

Secondary Outcome Measure Information:

Title

Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6

Description

Time Frame

Baseline and Week 6

Title

Change From Baseline in HAM-A Total Score at Weeks 2 and 4

Description

Time Frame

Baseline, Week 2, and Week 4

Title

Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6

Description

Time Frame

Baseline and Week 6

Title

Change From Baseline in HAM-A Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6

Description

Time Frame

Baseline and Week 6

Title

Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6

Description

Time Frame

Baseline and Week 6

Title

Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2 and 4

Description

Time Frame

Baseline, Week 2, and Week 4

Title

Change From Baseline in HDRS-17 Total Score at Weeks 2 and 4

Description

Time Frame

Baseline, Week 2, and Week 4

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

Description

Time Frame

Up to 8 weeks

Title

Total Plasma Concentration of JNJ-61393215

Description

Time Frame

1-4 hours postdose on Day 1; Predose and 1-4 hours post dose on Days 15, 29, and 43

Title

Plasma Protein Binding (PPB): Percentage of JNJ-61393215 Unbound

Description

Time Frame

Predose and 1-4 hours post dose on Day 43

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m^2) Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress, as assessed by the mini international neuropsychiatric inventory 7.0. Plus (MINI). Participants with a diagnosis of comorbid generalized anxiety disorder (GAD), post-traumatic stress disorder, persistent depressive disorder, attention deficit hyperactivity disorder (ADHD), social anxiety disorder or nicotine/caffeine dependence may be included, if MDD is primary diagnosis Participants must have an inventory of depressive symptomatology, clinician rating-30 (IDS-C30) total score greater than or equal to (>=) 35 (moderate to severe depression) Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the massachusetts general hospital antidepressant treatment history questionnaire (MGH-ATRQ) Participant must be currently receiving 1 of the following antidepressants for at least 6 weeks duration at screening, at an adequate therapeutic dose, as determined by the MGH-ATRQ and should remain on a stable dose throughout the study: bupropion, citalopram, escitalopram, sertraline, paroxetine, venlafaxine, desvenlafaxine, duloxetine, fluoxetine, vilazodone, vortioxetine, mirtazapine, agomelatine, nortriptyline, imipramine, amitriptyline and levomilnacipran Participants must have a suboptimal response (improvement <50%) to the antidepressant used as their current treatment, as measured by the MGH-ATRQ A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose Exclusion Criteria: Participant has any other 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 (example: bulimia, anorexia nervosa), or schizophrenia (lifetime) Age of onset of depression is after 55 years of age Participant has a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary) Participant has 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 Colombia suicide severity rating scale (C-SSRS) at screening or baseline Length of current major depressive episode >60 months Participant has organic brain disease or dementia or has known or suspected intellectual development disorder Participant has been treated with at least one of the following treatments: (a) electroconvulsive therapy in the current episode; (b) deep brain stimulation (lifetime); (c) repetitive transcranial magnetic stimulation within 4 weeks prior to baseline visit Participant has any clinically relevant medical condition that could potentially alter the absorption, metabolism, or excretion of the study intervention, such as liver disease or renal disease Participant has a relevant history of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures - uncomplicated childhood febrile seizures with no sequelae are not exclusionary) or significant cerebrovascular, renal, hepatic, dermatologic, hematologic, gastrointestinal or endocrine diseases. Hospitalization for cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack) within 3 months prior to the first administration of study drug is exclusionary. Diabetes mellitus be allowed when the participant is stable (HbA1c less than 7.5% or 58 mmol/mol) Participant has a clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening or baseline Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable.If at screening visit QTcB or QTcF interval >=450 ms for males or >=470 ms for females, or >480 ms if bundle branch block and prolongation of the QTc interval are present;participant is excluded Participant has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis

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:

Facility Name

Collaborative NeuroScience Network

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Atlanta Institute

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022

Country

United States

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

The Medical Research Network, LLC

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Facility Name

Richmond Behavioural Associates

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43220

Country

United States

Facility Name

IPS Research Company

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73106

Country

United States

Facility Name

Suburban Research Associates

City

Media

State/Province

Pennsylvania

ZIP/Postal Code

19063

Country

United States

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

ARENSIA

City

Chisinau

ZIP/Postal Code

MD2025

Country

Moldova, Republic of

Facility Name

City Clinical Psychiatric Hopsital 3

City

Moscow

ZIP/Postal Code

107076

Country

Russian Federation

Facility Name

Nizny Novgorod clinical psychiatric hospital 1

City

Nizny Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

Orenburg Regional Clinical Psychiatric Hospital #1

City

Orenburg

Country

Russian Federation

Facility Name

Medical and Rehabilitation Research Center Phoenix

City

Rostov-on-Don

ZIP/Postal Code

344010

Country

Russian Federation

Facility Name

Engels psychiatric hospital

City

Saratov Region

ZIP/Postal Code

413124

Country

Russian Federation

Facility Name

SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Saratov Regional Psychiatric hospital named after St. Sofia

City

Saratov

ZIP/Postal Code

410060

Country

Russian Federation

Facility Name

Psychoneurological dispensary 10

City

St-Petersburg

ZIP/Postal Code

190121

Country

Russian Federation

Facility Name

City Psychiatric hospital 7 named after I.P.Pavlov

City

St-Petersburg

ZIP/Postal Code

199034

Country

Russian Federation

Facility Name

Psychoneurological dispensary 1

City

St-Petersburg

ZIP/Postal Code

199178

Country

Russian Federation

Facility Name

Psychoneurological Dispensary #4

City

St.Peterburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Stavropol Region Psychiatric Hospital #2

City

Stavropol

ZIP/Postal Code

357034

Country

Russian Federation

Facility Name

Research Institute of Mental Health

City

Tomsk

ZIP/Postal Code

634014

Country

Russian Federation

Facility Name

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

City

Glevakha

ZIP/Postal Code

8630

Country

Ukraine

Facility Name

CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'

City

Ivano-Frankivsk

ZIP/Postal Code

76011

Country

Ukraine

Facility Name

Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

City

Kherson

ZIP/Postal Code

73488

Country

Ukraine

Facility Name

Kyiv Railway Station Clinical Hospital #2

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'

City

Nove, Kropyvnytskiy

ZIP/Postal Code

25491

Country

Ukraine

Facility Name

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

City

Smila

ZIP/Postal Code

20708

Country

Ukraine

Facility Name

CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

City

Vinnytsia

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

MAC Clinical Research

City

Barnsley

ZIP/Postal Code

S75 3DL

Country

United Kingdom

Facility Name

MAC Clinical Research

City

Liverpool

ZIP/Postal Code

L341BH

Country

United Kingdom

Facility Name

Kings College London

City

London

ZIP/Postal Code

SE5 8AZ

Country

United Kingdom

Facility Name

MAC Clinical Research

City

Manchester

ZIP/Postal Code

M139NQ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of JNJ-61393215 in the Treatment of Depression

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