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A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).

Primary Purpose

Depressive Episodes, Bipolar I Depression

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SEP-4199 CR
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:

  • Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
  • Subject has completed 6 weeks of double-blind treatment and all scheduled assessments from Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
  • Subject is medically appropriate for long-term open-label treatment with SEP-4199 CR in the opinion of the Investigator.
  • Female subjects of childbearing potential must agree to use highly effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken. In the Investigator's judgment, the subject will adhere to this requirement.
  • Male subjects agree to avoid fathering a child and to use highly effective methods of birth control throughout the study and until at least 90 days after the last study drug administration.

Exclusion Criteria:

  • Subject is at high risk of non-compliance in the opinion of the Investigator.
  • Subject plans to initiate treatment with a prohibited psychotropic medication during the study.
  • Subject plans to initiate treatment with transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the study.
  • Subject experienced a moderate or severe hyperprolactinemia-related AESI in the lead-in study of SEP-4199 CR.
  • Subject will require treatment with a drug that is associated with increases in QTc interval.
  • Subject had any of the following at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR based on machine reading:
  • increase in QTcF interval of ≥ 30 msec AND a QTcF interval ≥ 480 msec
  • increase in QTcF interval ≥ 60 msec
  • QTcF interval ≥ 500 msec
  • treatment-emergent clinically significant ECG abnormality.
  • Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, has a MADRS item 10 (suicidal ideation) score ≥ 4, or answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
  • Female subject has a positive urine pregnancy test at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR or plans to become pregnant during the current study.
  • Subject tests positive for any drug of abuse or cannabis at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR

Sites / Locations

  • University of Alabama at Birmingham Huntsville Regional Medical Campus
  • Advanced Research Center, Inc.
  • Sun Valley Research Center
  • Clinical innovations, Inc.
  • Collaborative Neuroscience Research, LLC
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Premier Clinical Research Institute, Inc
  • Clinical Neuroscience Solutions, Inc.
  • Atlanta Behavioral Research, LLC
  • Psych Atlanta, P.C.
  • AMR Conventions Research
  • St. Charles Psychiatric Associates / Midwest Research Group
  • Alivation Research, LLC
  • Center for Emotional Fitness
  • 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
  • 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"
  • 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
  • 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
  • DCC Mladost-M Varna OOD
  • 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
  • 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SEP-4199 CR

Arm Description

SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily

Outcomes

Primary Outcome Measures

The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation

Secondary Outcome Measures

Full Information

First Posted
January 27, 2022
Last Updated
June 12, 2023
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05227209
Brief Title
A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).
Official Title
A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of 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
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
May 31, 2029 (Anticipated)
Study Completion Date
May 31, 2029 (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
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. This study is accepting male and female participants between 18 and 65 years old who have completed Study SEP380-301. This study will be conducted in approximately 90 study centers worldwide. The treatment duration for this study is one (1) year.
Detailed Description
This is a 12-month open-label safety extension study to evaluate the long-term safety, tolerability, and effectiveness of SEP-4199 CR 200-400 mg/day in the treatment of subjects with bipolar I depression who previously completed a lead-in study of SEP-4199 CR. The study will consist of a 12-month open-label flexible-dose treatment period, and a safety follow-up period. There are 15 scheduled visits, including a Baseline visit, 13 visits during the open-label treatment period, and 1 safety follow-up visit 7 (± 2) days after the last dose of study drug. If necessary, subjects may return to the clinic at anytime for an unscheduled visit

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
Single Group Assignment
Model Description
This is a 12-month open-label safety extension study to evaluate the long-term safety, tolerability, and effectiveness of SEP-4199 CR 200-400 mg/day in the treatment of subjects with bipolar I depression who previously completed a lead-in study of SEP-4199 CR. The study will consist of a 12-month open-label flexible-dose treatment period, and a safety follow-up period
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
355 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEP-4199 CR
Arm Type
Experimental
Arm Description
SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily
Intervention Type
Drug
Intervention Name(s)
SEP-4199 CR
Intervention Description
SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily
Primary Outcome Measure Information:
Title
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation
Time Frame
52 Weeks

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: Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator. Subject has completed 6 weeks of double-blind treatment and all scheduled assessments from Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR. Subject is medically appropriate for long-term open-label treatment with SEP-4199 CR in the opinion of the Investigator. Female subjects of childbearing potential must agree to use effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken. In the Investigator's judgment, the subject will adhere to this requirement. Male subjects agree to avoid fathering a child and to use effective methods of birth control throughout the study and until at least 90 days after the last study drug administration. Exclusion Criteria: Subject is at high risk of non-compliance in the opinion of the Investigator. Subject plans to initiate treatment with a prohibited psychotropic medication during the study. Subject plans to initiate treatment with transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the study. Subject experienced a moderate or severe hyperprolactinemia-related AESI in the lead-in study of SEP-4199 CR. Subject will require treatment with a drug that is associated with increases in QTc interval. Subject had any of the following at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR based on machine reading: increase in QTcF interval of ≥ 30 msec AND a QTcF interval ≥ 480 msec, from baseline of the lead-in study of SEP-4199 CR AND a QTCF interval ≥ 480msec increase in QTcF interval ≥ 60 msec, from baseline of the lead-in study of SEP-4199 CR QTcF interval ≥ 500 msec treatment-emergent clinically significant ECG abnormality. Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, has a MADRS item 10 (suicidal ideation) score ≥ 4, or answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR. Female subject of childbearing potential, has a positive urine pregnancy test at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR or plans to become pregnant during the current study. Subject tests positive for any drug of abuse or cannabis at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR
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
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
Collaborative Neuroscience Research, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
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
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
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
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
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
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
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
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
Tsarev
ZIP/Postal Code
9747
Country
Bulgaria
Facility Name
DCC Mladost-M Varna OOD
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
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
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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study may be made available upon request via theVivli Center for Global Clinical Reserach 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 Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).

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