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A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

Primary Purpose

Depressive Episodes, Bipolar I Depression

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SEP-4199 CR 200 mg
SEP-4199 CR 400 mg
Placebo
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Episodes, Bipolar I Depression focused on measuring Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion Criteria (not all inclusive):

  • Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
  • Subject is 18 to 65 years of age, inclusive, at the time of informed consent.
  • Subject meets DSM-5 criteria, based on the SCID-5-CT, for bipolar I disorder, current episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features.
  • Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening.
  • Subject has a MADRS total score ≥ 22 at both Screening and Baseline.
  • Subject has a CGI-BP-S depression score ≥ 4 at both Screening and Baseline.
  • Subject has a YMRS total score ≤ 12 at both Screening and Baseline.
  • Subject is in good physical health, based on medical history, physical examination, neurological examination, vital signs, ECGs, and results of clinical laboratory tests (hematology, chemistry, and urinalysis).

Exclusion Criteria:

Exclusion Criteria (not all inclusive):

  • Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment in the past 6 months prior to Screening.
  • Subject has a lifetime history of, or symptoms consistent with, a major psychiatric diagnosis other than bipolar I disorder. These include (but are not limited to): schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or post-traumatic stress disorder.
  • Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode.
  • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study.

Sites / Locations

  • University of Alabama at Birmingham Huntsville Regional Medical Campus
  • Sanro Clinical Research Group LLC
  • Advanced Research Center, Inc.
  • Sun Valley Research Center
  • Clinical innovations, Inc.
  • Siyan Clinical Research
  • Collaborative Neuroscience Research, LLC
  • Vertex Research Group
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Premier Clinical Research Institute, Inc.
  • Central Miami Medical Institute
  • Clinical Neuroscience Solutions, Inc.
  • GCP Clinical Research LLC
  • Atlanta Behavioral Research, LLC
  • Psych Atlanta, P.C.
  • AMR Conventions Research
  • Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine
  • St. Charles Psychiatric Associates / Midwest Research Group
  • Alivation Research, LLC
  • Center for Emotional Fitness
  • Global Medical Institutes, LLC
  • UB Department of Psychiatry
  • Finger Lakes Clinical Research
  • Richmond Behavioral Associates ERG Clinical Research - New York PLLC
  • New Hope Clinical Research
  • Quest Therapeutics of Avon Lake
  • Neuro-Behavioral Clinical Research, Inc
  • Sooner Clinical Research
  • Lehigh Center for Clinical Research, LLC
  • Community Clinical Research, Inc.
  • UTHealth Science Center at Houston
  • Family Psychiatry of The Woodlands
  • Integrated Clinical Research
  • State Psychiatric Hospital - Kardzhali First Women Department Third Men Department
  • Medical Center Mentalcare OOD
  • Mental Health Center- Ruse EOOD,Men Department for treatment of persons with acute psychotic disorders; Women Department for treatment of persons with acute psychotic disorders; Department "Daily stationary"
  • State Psychiatric Hospital - s. Tsarev brod First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector
  • Mental Health Center - Sofia EOOD
  • Medical Center Sveti Naum EOOD
  • DCC St. Vrach and St. St. Kuzma and Damian OOD
  • Medical Center Hera EOOD
  • Medical Center Intermedica OOD
  • DCC Mladost-M Varna OOD 15, Republika Blvd., MC Mladost, 3rd floor
  • AMNDX Inc.
  • Hiro Mental Clinic
  • Shinseikai Kaku Mental Clinic
  • Mental Clinic Sakurazaka
  • Someikai Kanagami Clinic
  • Kokura Mental Clinic
  • Hatakeyama Clinic
  • Hirota Clinic
  • Shiranui Hospital
  • Jisenkai Nanko Psychiatric Institute
  • Teine Keijinkai Hospital
  • Tatsuta Clinic
  • Cerisier Heart Clinic
  • Musashikosugi J Kokorono Clinic
  • Yutaka Clinic
  • Azamino Mental Clinic
  • Yamatenomori Kokorono Clinic
  • Satokai Yuge Hospital
  • Akari Clinic
  • Shiroma Clinic
  • Rainbow & Sea Hospital
  • Juntendo University Hospital
  • Senzoku Psychosomatic Clinic
  • Minami-Aoyama Antique Street Clinic
  • Heart Care Ginga Clinic
  • Sangenjaya Nakamura Mental Clinic
  • Sangenjaya Neurology- Psychosomatic Clinic
  • Japanese Red Cross Medical Center
  • Maynds Tower Mental Clinic
  • Sangubashi Kokorono Clinic
  • Etoh Mental Clinic
  • Tamaki Clinic
  • Himorogi Psychiatric Institute
  • Uguisudani Mental Clinic
  • Ohwa Mental Clinic
  • Kitaikebukuro Kokoro No Clinic
  • Spitalul Clinic de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinică I
  • Spitalul Clinic de Psihiatrie ''Prof. Dr. Alexandru Obregia''
  • Sectia Psihiatrie, Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", Sectia Psihiatrie
  • Spitalul Clinic de Psihiatrie
  • Institutul Privat De Cercetări Melchisedec, Pentru Boli Autoimune, Ereditare Şi Rare - I.P.C.M.
  • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie I Femei
  • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
  • PsychoLine s. r. o., Psychiatricka ambulancia
  • Crystal Comfort s.r.o., Psychiatricka ambulancia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SEP-4199 CR 200 mg

SEP-4199 CR 400 mg

Placebo

Arm Description

SEP-4199 CR 200 mg/day

SEP-4199 CR 400 mg/day

Placebo

Outcomes

Primary Outcome Measures

Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score
The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms.

Secondary Outcome Measures

Change from Baseline to Week 6 in Clinical Global Impressions-Severity: Bipolar Version (CGI-BP-S) depression score
Clinical Global Impressions - Severity: Bipolar Version (CGI-BP-S) is clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.

Full Information

First Posted
December 13, 2021
Last Updated
September 25, 2023
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05169710
Brief Title
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
Official Title
A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.
Detailed Description
This study is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 CR at fixed doses of 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episode associated with bipolar I disorder (bipolar I depression). The study is projected to randomize approximately 522 subjects inNorth America, Japan, Europe and Latin America, to SEP-4199 CR 200 mg/day, SEP-4199 CR 400 mg/day, and placebo treatment groups in a 1:1:1 ratio

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Episodes, Bipolar I Depression
Keywords
Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
522 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEP-4199 CR 200 mg
Arm Type
Experimental
Arm Description
SEP-4199 CR 200 mg/day
Arm Title
SEP-4199 CR 400 mg
Arm Type
Experimental
Arm Description
SEP-4199 CR 400 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SEP-4199 CR 200 mg
Intervention Description
SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
Intervention Type
Drug
Intervention Name(s)
SEP-4199 CR 400 mg
Intervention Description
SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet (supplied in two tablets)
Primary Outcome Measure Information:
Title
Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Description
The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 6 in Clinical Global Impressions-Severity: Bipolar Version (CGI-BP-S) depression score
Description
Clinical Global Impressions - Severity: Bipolar Version (CGI-BP-S) is clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.
Time Frame
Baseline and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria (not all inclusive): Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator. Subject is 18 to 65 years of age, inclusive, at the time of informed consent. Subject meets DSM-5 criteria, based on the SCID-5-CT, for bipolar I disorder, current episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening. Subject has a MADRS total score ≥ 22 at both Screening and Baseline. Subject has a CGI-BP-S depression score ≥ 4 at both Screening and Baseline. Subject has a YMRS total score ≤ 12 at both Screening and Baseline. Subject is in good physical health, based on medical history, physical examination, neurological examination, vital signs, ECGs, and results of clinical laboratory tests (hematology, chemistry, and urinalysis). Exclusion Criteria: Exclusion Criteria (not all inclusive): Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment, or is currently being treated with concomitant medication Subject has a lifetime history of, or symptoms consistent with, schizophrenia, schizoaffective disorder, or a major psychiatric diagnosis other than bipolar I disorder that is judged to pose risk to the study scientific objectives Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CNS Medical Director
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Huntsville Regional Medical Campus
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Sanro Clinical Research Group LLC
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Clinical innovations, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Siyan Clinical Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Vertex Research Group
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Premier Clinical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Central Miami Medical Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
GCP Clinical Research LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Atlanta Behavioral Research, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Psych Atlanta, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
AMR Conventions Research
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
St. Charles Psychiatric Associates / Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Global Medical Institutes, LLC
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
UB Department of Psychiatry
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Quest Therapeutics of Avon Lake
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Lehigh Center for Clinical Research, LLC
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
UTHealth Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Family Psychiatry of The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Integrated Clinical Research
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
State Psychiatric Hospital - Kardzhali First Women Department Third Men Department
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Facility Name
Medical Center Mentalcare OOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Mental Health Center- Ruse EOOD,Men Department for treatment of persons with acute psychotic disorders; Women Department for treatment of persons with acute psychotic disorders; Department "Daily stationary"
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
State Psychiatric Hospital - s. Tsarev brod First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector
City
S. Tsarev Brod
ZIP/Postal Code
9747
Country
Bulgaria
Facility Name
Mental Health Center - Sofia EOOD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Medical Center Sveti Naum EOOD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
DCC St. Vrach and St. St. Kuzma and Damian OOD
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Medical Center Intermedica OOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
DCC Mladost-M Varna OOD 15, Republika Blvd., MC Mladost, 3rd floor
City
Varna
ZIP/Postal Code
0920
Country
Bulgaria
Facility Name
AMNDX Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3R 1A3
Country
Canada
Facility Name
Hiro Mental Clinic
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
810-0004
Country
Japan
Facility Name
Shinseikai Kaku Mental Clinic
City
Fukuoka-Shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
810-0022
Country
Japan
Facility Name
Mental Clinic Sakurazaka
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
810-0023
Country
Japan
Facility Name
Someikai Kanagami Clinic
City
Kitakyushu-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
800-0226
Country
Japan
Facility Name
Kokura Mental Clinic
City
Kitakyushu-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
802-0006
Country
Japan
Facility Name
Hatakeyama Clinic
City
Kitakyusyu-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
802-0064
Country
Japan
Facility Name
Hirota Clinic
City
Kurume-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
830-0033
Country
Japan
Facility Name
Shiranui Hospital
City
Omuta-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
836-0004
Country
Japan
Facility Name
Jisenkai Nanko Psychiatric Institute
City
Shirakawa-shi
State/Province
Fukushima-Ken
ZIP/Postal Code
961-0021
Country
Japan
Facility Name
Teine Keijinkai Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
Tatsuta Clinic
City
Kobe-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
651-0097
Country
Japan
Facility Name
Cerisier Heart Clinic
City
Kagoshima-shi
State/Province
Kagoshima-Ken
ZIP/Postal Code
890-0069
Country
Japan
Facility Name
Musashikosugi J Kokorono Clinic
City
Kawasaki-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
211-0004
Country
Japan
Facility Name
Yutaka Clinic
City
Sagamihara-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
252-0303
Country
Japan
Facility Name
Azamino Mental Clinic
City
Yokohama-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
225-0011
Country
Japan
Facility Name
Yamatenomori Kokorono Clinic
City
Yokohama-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
231-0846
Country
Japan
Facility Name
Satokai Yuge Hospital
City
Kumamoto-shi
State/Province
Kumamoto-ken
ZIP/Postal Code
861-8002
Country
Japan
Facility Name
Akari Clinic
City
Naha-shi
State/Province
Okinawa-ken
ZIP/Postal Code
900-0004
Country
Japan
Facility Name
Shiroma Clinic
City
Urasoe-shi
State/Province
Okinawa-ken
ZIP/Postal Code
901-2102
Country
Japan
Facility Name
Rainbow & Sea Hospital
City
Karatsu-shi
State/Province
Saga-Ken
ZIP/Postal Code
847-0031
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo-To
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Senzoku Psychosomatic Clinic
City
Meguro-ku
State/Province
Tokyo-To
ZIP/Postal Code
152-0012
Country
Japan
Facility Name
Minami-Aoyama Antique Street Clinic
City
Minato-ku
State/Province
Tokyo-To
ZIP/Postal Code
107-0062
Country
Japan
Facility Name
Heart Care Ginga Clinic
City
Nakano-ku
State/Province
Tokyo-To
ZIP/Postal Code
164-0012
Country
Japan
Facility Name
Sangenjaya Nakamura Mental Clinic
City
Setagaya-ku
State/Province
Tokyo-To
ZIP/Postal Code
154-0004
Country
Japan
Facility Name
Sangenjaya Neurology- Psychosomatic Clinic
City
Setagaya-ku
State/Province
Tokyo-To
ZIP/Postal Code
154-0004
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-ku
State/Province
Tokyo-To
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Maynds Tower Mental Clinic
City
Shibuya-ku
State/Province
Tokyo-To
ZIP/Postal Code
151-0053
Country
Japan
Facility Name
Sangubashi Kokorono Clinic
City
Shibuya-ku
State/Province
Tokyo-To
ZIP/Postal Code
151-0053
Country
Japan
Facility Name
Etoh Mental Clinic
City
Shinagawa-ku
State/Province
Tokyo-To
ZIP/Postal Code
141-0021
Country
Japan
Facility Name
Tamaki Clinic
City
Shinjuku-ku
State/Province
Tokyo-To
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Himorogi Psychiatric Institute
City
Shinjuku-ku
State/Province
Tokyo-To
ZIP/Postal Code
162-0843
Country
Japan
Facility Name
Uguisudani Mental Clinic
City
Taito-ku
State/Province
Tokyo-To
ZIP/Postal Code
110-0003
Country
Japan
Facility Name
Ohwa Mental Clinic
City
Toshima-ku
State/Province
Tokyo-To
ZIP/Postal Code
170-0002
Country
Japan
Facility Name
Kitaikebukuro Kokoro No Clinic
City
Toshima-ku
State/Province
Tokyo-To
ZIP/Postal Code
170-0011
Country
Japan
Facility Name
Spitalul Clinic de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinică I
City
Brasov
ZIP/Postal Code
500123
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie ''Prof. Dr. Alexandru Obregia''
City
Bucuresti
ZIP/Postal Code
040874
Country
Romania
Facility Name
Sectia Psihiatrie, Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", Sectia Psihiatrie
City
Bucuresti
ZIP/Postal Code
060222
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie
City
București
ZIP/Postal Code
041914
Country
Romania
Facility Name
Institutul Privat De Cercetări Melchisedec, Pentru Boli Autoimune, Ereditare Şi Rare - I.P.C.M.
City
Craiova
ZIP/Postal Code
200157
Country
Romania
Facility Name
Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie I Femei
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
PsychoLine s. r. o., Psychiatricka ambulancia
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Crystal Comfort s.r.o., Psychiatricka ambulancia
City
Vranov And Toplou
ZIP/Postal Code
093 01
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data Site
IPD Sharing Time Frame
IPD will be made available upon request within 12 months of posting the study results on ct.gov.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://vivli.org

Learn more about this trial

A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

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