Back to resultsA Study of JNJ-55308942 in the Treatment of Bipolar Depression
Primary Purpose
Bipolar Disorder
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-55308942
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria:
- Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI)
- Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
- Have a body mass index (BMI) between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive (BMI = weight/height^2)
- A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test before the first dose of study intervention
Exclusion Criteria:
- Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI
- Received transcranial magnetic stimulation (TMS), any transcranial electrical stimulation, including transcranial direct current stimulation (tDCS), vagal nerve stimulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior to randomization
- History of moderate to severe cannabis misuse according to DSM-5 criteria within 6 months before screening
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
Sites / Locations
- UAB Huntsville Regional Medical CampusRecruiting
- Preferred Research PartnersRecruiting
- Collaborative NeuroScience NetworkRecruiting
- Clinical Neuroscience Solutions IncRecruiting
- Clinical Neuroscience SolutionsRecruiting
- Psychiatric Medicine Associates LLCRecruiting
- Indiana UniversityRecruiting
- Center for Emotional Fitness
- Richard H. Weisler, MD & AssociatesRecruiting
- Case Western Reserve School of MedicineRecruiting
- The Ohio State UniversityRecruiting
- Suburban Research AssociatesRecruiting
- Clinical NeuroScience Solutions, IncRecruiting
- The University of Texas at Austin Department of Psychiatry, Dell Medical SchoolRecruiting
- The University of Texas Health Science Center at Houston
- Northwest Clinical Research CenterRecruiting
- The Medical Arts Health Research GroupRecruiting
- Chatham-Kent Clinical Trials Research CentreRecruiting
- Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika PsychiatriiRecruiting
- PROMENTE Sp. z o.o.Recruiting
- Centrum Badań Klinicznych PI-House sp. z o.o.Recruiting
- Specjalistyczna Praktyka Lekarska Piotr ZalitaczRecruiting
- Centrum Medyczne Care Clinic KatowiceRecruiting
- Indywidualna Praktyka Lekarska Kinga BobinskaRecruiting
- Filip Rybakowski Specjalistyczna Praktyka LekarskaRecruiting
- Centrum Medyczne HCP Sp. z o.o. Osrodek Badan KlinicznychRecruiting
- Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach SlaskichRecruiting
- Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger MolendaRecruiting
- Szpital Nowowiejski Osrodek Badan KlinicznychRecruiting
- Instytut Psychiatrii I NeurologiiRecruiting
- Przychodnia Lekarsko-Psychologiczna PersonaRecruiting
- Ginemedica Sp. z o.o.Recruiting
- Hosp. Del MarRecruiting
- Institucion Hosp Hestia PalauRecruiting
- Hosp. Clinic I Provincial de BarcelonaRecruiting
- Hosp. Univ. Ramon Y CajalRecruiting
- Centro Salud Mental La EriaRecruiting
- Clinica Univ. de NavarraRecruiting
- Hosp. El BierzoRecruiting
- Hosp. Univ. I Politecni La FeRecruiting
- Hosp. Alvaro CunqueiroRecruiting
- Hosp. Psiquiatrico AlavaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
JNJ-55308942
Placebo
Arm Description
Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.
Participants will receive a matching placebo capsule once daily for 6 weeks.
Outcomes
Primary Outcome Measures
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
Change from baseline in MADRS total score at Week 6 will be reported. The 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.
Secondary Outcome Measures
Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 6
Change from baseline in SHAPS total score at Week 6 will be reported.
Change from Baseline in MADRS Total Score at Week 6 (Genetic Subgroup Analysis)
Change from baseline in MADRS total score at Week 6 in participants who are heterozygous or homozygous for a specific single nucleotide polymorphism (SNP) (genetic subgroup analysis) will be reported.
Change from Baseline in MADRS Total Score at Week 6 (Diagnosis Subgroup Analysis)
Change from Baseline in MADRS total score at Week 6 in participants with bipolar disorder (BD) diagnostic subtypes (diagnosis subgroup analysis) will be reported.
Change from Baseline in MADRS Total Score at Week 6 (Biomarker Subgroup Analysis)
Change from baseline in MADRS total score at Week 6 in subgroups of participants with specific biomarker profiles (biomarker subgroup analysis) will be reported.
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (pulse/heart rate, systolic blood pressure [SBP], diastolic blood pressure [DBP], respiratory rate) will be reported.
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (chemistry, hematology, urinalysis) will be reported.
Number of Participants with Adverse Events (AEs)
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.
Number of Participants with Abnormalities in Electrocardiograms (ECGs)
Number of participants with abnormalities in ECG will be reported.
Change from Baseline in Young Mania Rating Scale (YMRS) Score
Change from baseline in YMRS score will be reported. The YMRS is a rating scale used to assess manic symptoms.
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Change from baseline in C-SSRS score will be reported.
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score
Change from baseline in CGI-S scale score will be reported.
Plasma Concentrations of JNJ-55308942
Plasma samples will be analyzed to determine concentrations of JNJ-55308942 using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
Change from Baseline in Patient Reported Outcome Measurement (PROMIS) Score - Ability to Participate in Social Roles and Activities Scores
Change from baseline in PROMIS score- ability to participate in social roles and activity scores score will be reported. Participation in social roles and activities item bank assesses the perceived ability to perform one's usual social roles and activities.
Change from Baseline in Patient Health Questionnaire (PHQ-9) Score
Change from baseline in PHQ-9 will be reported. PHQ-9 score used to assess the severity of depression in the participants.
Change from Baseline in Generalized Anxiety Disorder 7 (GAD-7) Score.
Change from baseline in GAD-7 score will be reported.
Percentage of Participants with Response at Week 6
Percentage of participants with response (greater than or equal to [>=] 50 percent [%] improvement in MADRS total score) at Week 6 will be reported.
Number of Participants with Remission at Week 6
Number of participants with remission (MADRS total score less than or equal to [<=] 12) at Week 6 will be reported.
Change from Baseline in MADRS Total Score at Week 6 (Subgroup of Participants with Messenger Ribonucleic Acid [mRNA] Transcript Levels)
Change from baseline in MADRS total score at Week 6 in participants with levels of specific mRNA transcripts that exceed the median level will be reported.
Change from Baseline in MADRS Total Score at Week 6 (Mood Stabilizer Subgroup Analysis)
Change from baseline in MADRS total score at Week 6 in subgroup of participants with BD not taking any mood stabilizer or antipsychotic, taking a mood stabilizer alone, taking an antipsychotic alone, and taking a combination of a mood stabilizer and an antipsychotic (concomitant medication subgroup analysis) will be reported.
Full Information
NCT ID
NCT05328297
First Posted
April 11, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Pharmaceutica N.V., Belgium
1. Study Identification
Unique Protocol Identification Number
NCT05328297
Brief Title
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
Official Title
A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
March 22, 2024 (Anticipated)
Study Completion Date
March 13, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutica N.V., Belgium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JNJ-55308942
Arm Type
Experimental
Arm Description
Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a matching placebo capsule once daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
JNJ-55308942
Intervention Description
JNJ-55308942 capsules will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules will be administered orally.
Primary Outcome Measure Information:
Title
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
Description
Change from baseline in MADRS total score at Week 6 will be reported. The 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.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 6
Description
Change from baseline in SHAPS total score at Week 6 will be reported.
Time Frame
Baseline and Week 6
Title
Change from Baseline in MADRS Total Score at Week 6 (Genetic Subgroup Analysis)
Description
Change from baseline in MADRS total score at Week 6 in participants who are heterozygous or homozygous for a specific single nucleotide polymorphism (SNP) (genetic subgroup analysis) will be reported.
Time Frame
Baseline and Week 6
Title
Change from Baseline in MADRS Total Score at Week 6 (Diagnosis Subgroup Analysis)
Description
Change from Baseline in MADRS total score at Week 6 in participants with bipolar disorder (BD) diagnostic subtypes (diagnosis subgroup analysis) will be reported.
Time Frame
Baseline and Week 6
Title
Change from Baseline in MADRS Total Score at Week 6 (Biomarker Subgroup Analysis)
Description
Change from baseline in MADRS total score at Week 6 in subgroups of participants with specific biomarker profiles (biomarker subgroup analysis) will be reported.
Time Frame
Baseline and Week 6
Title
Number of Participants with Abnormalities in Vital Signs
Description
Number of participants with abnormalities in vital signs (pulse/heart rate, systolic blood pressure [SBP], diastolic blood pressure [DBP], respiratory rate) will be reported.
Time Frame
Up to Week 8
Title
Number of Participants with Abnormalities in Clinical Laboratory Tests
Description
Number of participants with abnormalities in clinical laboratory tests (chemistry, hematology, urinalysis) will be reported.
Time Frame
Up to Week 8
Title
Number of Participants with Adverse Events (AEs)
Description
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.
Time Frame
Up to Week 8
Title
Number of Participants with Abnormalities in Electrocardiograms (ECGs)
Description
Number of participants with abnormalities in ECG will be reported.
Time Frame
Up to Week 8
Title
Change from Baseline in Young Mania Rating Scale (YMRS) Score
Description
Change from baseline in YMRS score will be reported. The YMRS is a rating scale used to assess manic symptoms.
Time Frame
Baseline up to Week 6
Title
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Description
Change from baseline in C-SSRS score will be reported.
Time Frame
Baseline up to Week 8
Title
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score
Description
Change from baseline in CGI-S scale score will be reported.
Time Frame
Baseline up to Week 6
Title
Plasma Concentrations of JNJ-55308942
Description
Plasma samples will be analyzed to determine concentrations of JNJ-55308942 using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
Time Frame
Days 1, 8, 15, 29, 43
Title
Change from Baseline in Patient Reported Outcome Measurement (PROMIS) Score - Ability to Participate in Social Roles and Activities Scores
Description
Change from baseline in PROMIS score- ability to participate in social roles and activity scores score will be reported. Participation in social roles and activities item bank assesses the perceived ability to perform one's usual social roles and activities.
Time Frame
Baseline, up to Week 6
Title
Change from Baseline in Patient Health Questionnaire (PHQ-9) Score
Description
Change from baseline in PHQ-9 will be reported. PHQ-9 score used to assess the severity of depression in the participants.
Time Frame
Baseline up to Week 6
Title
Change from Baseline in Generalized Anxiety Disorder 7 (GAD-7) Score.
Description
Change from baseline in GAD-7 score will be reported.
Time Frame
Baseline up to Week 6
Title
Percentage of Participants with Response at Week 6
Description
Percentage of participants with response (greater than or equal to [>=] 50 percent [%] improvement in MADRS total score) at Week 6 will be reported.
Time Frame
Week 6
Title
Number of Participants with Remission at Week 6
Description
Number of participants with remission (MADRS total score less than or equal to [<=] 12) at Week 6 will be reported.
Time Frame
Week 6
Title
Change from Baseline in MADRS Total Score at Week 6 (Subgroup of Participants with Messenger Ribonucleic Acid [mRNA] Transcript Levels)
Description
Change from baseline in MADRS total score at Week 6 in participants with levels of specific mRNA transcripts that exceed the median level will be reported.
Time Frame
Baseline and Week 6
Title
Change from Baseline in MADRS Total Score at Week 6 (Mood Stabilizer Subgroup Analysis)
Description
Change from baseline in MADRS total score at Week 6 in subgroup of participants with BD not taking any mood stabilizer or antipsychotic, taking a mood stabilizer alone, taking an antipsychotic alone, and taking a combination of a mood stabilizer and an antipsychotic (concomitant medication subgroup analysis) will be reported.
Time Frame
Baseline and Week 6
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:
Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI)
Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
Have a body mass index (BMI) between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive (BMI = weight/height^2)
A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test before the first dose of study intervention
Exclusion Criteria:
Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI
Received transcranial magnetic stimulation (TMS), any transcranial electrical stimulation, including transcranial direct current stimulation (tDCS), vagal nerve stimulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior to randomization
History of moderate to severe cannabis misuse according to DSM-5 criteria within 6 months before screening
History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutica N.V., Belgium Clinical Trial
Organizational Affiliation
Janssen Pharmaceutica N.V., Belgium
Official's Role
Study Director
Facility Information:
Facility Name
UAB Huntsville Regional Medical Campus
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Collaborative NeuroScience Network
City
Torrance
State/Province
California
ZIP/Postal Code
90504
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
23801
Country
United States
Individual Site Status
Recruiting
Facility Name
Psychiatric Medicine Associates LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Individual Site Status
Completed
Facility Name
Richard H. Weisler, MD & Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609-9148
Country
United States
Individual Site Status
Recruiting
Facility Name
Case Western Reserve School of Medicine
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical NeuroScience Solutions, Inc
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas at Austin Department of Psychiatry, Dell Medical School
City
Austin
State/Province
Texas
ZIP/Postal Code
78712-1873
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
The Medical Arts Health Research Group
City
West Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Chatham-Kent Clinical Trials Research Centre
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 1C1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii
City
Bialystok
ZIP/Postal Code
15-272
Country
Poland
Individual Site Status
Recruiting
Facility Name
PROMENTE Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-133
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badań Klinicznych PI-House sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
City
Gorlice
ZIP/Postal Code
30073
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Care Clinic Katowice
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Individual Site Status
Recruiting
Facility Name
Indywidualna Praktyka Lekarska Kinga Bobinska
City
Lodz
ZIP/Postal Code
90-009
Country
Poland
Individual Site Status
Recruiting
Facility Name
Filip Rybakowski Specjalistyczna Praktyka Lekarska
City
Poznan
ZIP/Postal Code
60-744
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych
City
Poznań
ZIP/Postal Code
61-485
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich
City
Siemianowice Slaskie
ZIP/Postal Code
41-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
City
Suchy Las
ZIP/Postal Code
62-002
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Nowowiejski Osrodek Badan Klinicznych
City
Warszawa
ZIP/Postal Code
00-774
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Psychiatrii I Neurologii
City
Warszawa
ZIP/Postal Code
02957
Country
Poland
Individual Site Status
Recruiting
Facility Name
Przychodnia Lekarsko-Psychologiczna Persona
City
Wroclaw
ZIP/Postal Code
50-227
Country
Poland
Individual Site Status
Recruiting
Facility Name
Ginemedica Sp. z o.o.
City
Wrocław
ZIP/Postal Code
50-414
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institucion Hosp Hestia Palau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Salud Mental La Eria
City
Oviedo
ZIP/Postal Code
33013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. El Bierzo
City
Ponferrada
ZIP/Postal Code
24404
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36213
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Psiquiatrico Alava
City
Vitoria-Gasteiz
ZIP/Postal Code
1006
Country
Spain
Individual Site Status
Recruiting
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-55308942 in the Treatment of Bipolar Depression
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