A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression

NCT03543410 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: SEP380-2012018-000103-16
• Study Type: interventional
• Target: 344
• Locations: 8 countries
• Sites: 87

Brief Summary

A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression

Conditions

Depressive Episode; Bipolar 1 Depression

Keywords

Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6

  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 ranging from 0 to 6. The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms

  6 Weeks

Secondary Outcomes (1)

• Change From Baseline in Global Severity Assessed by the Clinical Global Impressions - Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6

  6 Weeks

Study Arms (3)

SEP-4199 200 mg

EXPERIMENTAL

SEP-4199 200 mg/day (supplied in two 100mg tablets)

Drug: SEP-4199 200 mg

SEP-4199 400 mg

EXPERIMENTAL

SEP-4199 400 mg/day (supplied in two 200mg tablets)

Drug: SEP-4199 400 mg

Placebo

PLACEBO COMPARATOR

Placebo (supplied in two tablets/day

Drug: Placebo

Interventions

SEP-4199 200 mg DRUG

SEP-4199 200 mg/day (supplied in two 100mg tablets)

SEP-4199 200 mg

SEP-4199 400 mg DRUG

SEP-4199 400 mg/day (supplied in two 200mg tablets

SEP-4199 400 mg

Placebo DRUG

Placebo (supplied in two tablets/day)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 to 65 years of age, inclusive, at the time of informed consent with 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 (diagnosed by DSM 5 criteria, and confirmed by the SCID 5 CT). The current episode of major depression associated with bipolar I disorder must be confirmed by the Investigator and noted in the source records.
• Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.
• Subject or legally acceptable representative must possess an educational level and degree of understanding of English or the local language that enables them to communicate suitably with the Investigator and the study coordinator.
• Subject must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (e.g., family member or caregiver) be available to confirm this history.
• 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 YMRS total score ≤ 12 at Screening.
• Female subjects of childbearing potential must have a negative serum ß-hCG test at Screening.
• Females who participate in this study must be . one of the following:
• unable to become pregnant (e.g., postmenopausal, surgically sterile, etc.) -OR-
• Practicing abstinence or part of an abstinent lifestyle
• using and willing to continue using a highly effective form of birth control for at least 28 days prior to administration of the first dose of study drug, during the treatment period, and 2 months after completion or premature discontinuation from the study drug.
• Male subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or using protocol-specified methods of birth control. See Section 10.4 for further information on acceptable methods of birth control.
• Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
• Subject's random screening glucose is \< 200 mg/dL (11.1 mmol/L).

You may not qualify if:

• Subject demonstrates a decrease (improvement) of ≥ 25% in MADRS total score from Screening to Baseline, or subject's MADRS total score is \< 22 at Baseline.
• Subject has received treatment with antidepressants within 3 days of randomization, fluoxetine at any time within 28 days, an MAO inhibitor within 21 days or clozapine within 120 days. All other psychotropic medications with the exceptions of lorazepam, temazepam,eszopiclone, zopiclone, zolpidem and zolpidem CR require 3 days minimum washout. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization.
• Subject has suspected/confirmed Borderline Personality Disorder
• Subject currently has a clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with a known history of HIV seropositivity will be excluded.
• Subject has a history of malignancy \< 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Subjects with pituitary tumors of any duration are excluded.
• Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation (use screening values for laboratory evaluation). Subject has a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications.
• Subject has knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders, or requires treatment with an antiarrhythmic medication.
• Subject has family history of QTc prolongation or of unexplainable sudden death at \< 50 years of age.
• Abnormal 12 lead ECG at Screening, including:
• QTcF \> 450 ms (male subjects) or \> 470 ms (female subjects)
• QRS \> 110 ms
• PR \> 200 ms
• Second- or third-degree atrioventricular block
• Any rhythm other than sinus rhythm, which is interpreted by the Investigator to be clinically significant
• Subject has a history of neuroleptic malignant syndrome (NMS).

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (87)

CNS Research Science, Inc.

Cerritos, California, 90703, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Artemis Insitute for Clinical Research

San Diego, California, 92103, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Eastside Therapeutic Resource dba Core Clinical Research

Everett, Washington, 98201, United States

Location

Mental Health Centre -Prof. Dr. Ivan Temkov - Burgas EOOD

Burgas, 8000, Bulgaria

Location

State Psychiatric Hospital-Kardzhali

Kardzhali, 6600, Bulgaria

Location

MHAT-Dr. Hristo Stambolski EOOD, Department of Psychiatry

Kazanlak, 6100, Bulgaria

Location

Mental Health Center - Ruse EOOD

Rousse, 7003, Bulgaria

Location

Neli Nikolova Todorova, MD ,State Psychatric Hospital - s. Tsarev brod

Shumen, 9747, Bulgaria

Location

Mental Health Center - Sofia EOOD

Sofia, 1202, Bulgaria

Location

Fukuoka University Hospital

Fukuoka, Japan

Location

Hatakeyama Clinic, Department of Psychiatry

Fukuoka, Japan

Location

Hiro Mental Clinic, Department of Psychiatry

Fukuoka, Japan

Location

Kokura Mental Clinic

Fukuoka, Japan

Location

Kuramitsu Hospital, Department of Psychiatry

Fukuoka, Japan

Location

Shinseikai Kaku Mental Clinic, Department of Psychiatry

Fukuoka, Japan

Location

Someikai Kanagami Clinic, Department of Psychiatry

Fukuoka, Japan

Location

Jisenkai Nanko Psychiatric Institute, Department of Psychiatry

Fukushima, Japan

Location

Takahashi Psychiatric Clinic

Hyōgo, Japan

Location

Azamino Mental clinic, Department of Psychiatry

Kanagawa, Japan

Location

Medical Corporation Seishinkai Kishiro Mental Clinic, Department of Psychiatry

Kanagawa, Japan

Location

Musashikosugi J. Kokorono Clinic

Kanagawa, Japan

Location

Yokohama Onoecho Clinic, Department of Psychiatry

Kanagawa, Japan

Location

Yutaka Clinic

Kanagawa, Japan

Location

SagaArashiyama / Tanaka Clinic, Department of Psychiatry

Kyoto, Japan

Location

Minami-aoyama Anique Street Clinic, Department of Psychiatry

Minato-Ku, Tokyo, Japan

Location

Clinic Sophia

Okayama, Japan

Location

Nagaokai Neyagawa Sanitorium

Osaka, 572-0854, Japan

Location

Asakayama Hospital

Osaka, Japan

Location

Koshokai Ainhanazono Hospital

Osaka, Japan

Location

Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital

Osaka, Japan

Location

Etoh Mental Clinic Meguro, Department of Psychiatry

Tokyo, Japan

Location

Himorogi Psychiatric Institute, Department of Psychiatry

Tokyo, Japan

Location

JCHO Yokyo Shinjuku Medical Center

Tokyo, Japan

Location

Jisenkai Hozumi Himorogi Clinic, Department of Psychiatry

Tokyo, Japan

Location

Maynds Tower Mental Clinic, Department of Psychiatry

Tokyo, Japan

Location

Nishi-shinjuku Concieria Clnic

Tokyo, Japan

Location

Ohwa Mental clinic, Department of Psychiatry

Tokyo, Japan

Location

Sangenjaya Nakamura Mental Clinic, Department of Psychiatry

Tokyo, Japan

Location

Sangenjaya Neurology-Psychosomatic Clinic, Department of Psychiatry

Tokyo, Japan

Location

Senzoku Psychosomatic Clinic, Department of Psychiatry

Tokyo, Japan

Location

Shinjuku Research Park Clinic

Tokyo, Japan

Location

Tamaki Clinic, Department of Psychiatry

Tokyo, Japan

Location

Uguisudani Mental Clinic, Department of Psychiatry

Tokyo, Japan

Location

Yoyogi Mental Clinic

Tokyo, Japan

Location

Przychodnia Srodmiescie Sp. z.o.o.

Bydgoszcz, 85-080, Poland

Location

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, 64-100, Poland

Location

Specjalistyczna Praktyka Lekarska Marek Domanski

Lublin, Poland

Location

Filip Rybakowski Specjalistyczna Praktka Lekarska

Poznan, 60-744, Poland

Location

Poradnia Zdrowia Psychicznego "Syntonia"

Pruszcz Gdański, 83-000, Poland

Location

Gabinet Lekarski Torunskie Centrum PsychiatriI NEUROMED

Torun, 87-100, Poland

Location

Osrodek Badan Klinicznych Clinsante Spolka Cywilna

Torun, 87-100, Poland

Location

Lipetsk regional psychoneurological hospital

Lipetsk, 398007, Russia

Location

State Budgetary Institution of Healthare of the City of Moscow "Psychiatric clinical Hospital #4 n.a. P.B. Gannushkin of the Department of Healthcare of the City o Moscow" Branch "Psychiatric hospital n.a. V.A. Gilyarovsky"

Moscow, 107076, Russia

Location

State Budgetary Institution of Healthcare of Nizhniy Novgorod region "Clinical Psychiatric Hospital #1 of Nizhniy Novgorod"

Nizhny Novgorod, 603155, Russia

Location

Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital named after N.N. Solodnikov"

Omsk, 644070, Russia

Location

Limited Liability Company "Treatment and Rehabilitational Scientific Center Phoenix"

Rostov-on-Don, 344000, Russia

Location

Saint Petersburg State Institution of Healthcare "Psychiatric Hospital of Sain Nikolai hudotvorets "

Saint Petersburg, 190121, Russia

Location

Federal State Budgetary Institution "National Medical Research Centre of psychiatry and nuerology named after V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation, department #12

Saint Petersburg, 192019, Russia

Location

Stain Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensary #1"

Saint Petersburg, 199106, Russia

Location

State Institution of Healtcare "Regional Clinical Psychiatric Hospital of Saint Sofia"

Saratov, 410060, Russia

Location

Limited Liability Company "Clinic StoLet"

Tomsk, 634009, Russia

Location

Bel Medic General Hospital

Belgrade, 11000, Serbia

Location

Clinical Center "Dr. Dragisa Misovic-Dedinje"

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

General Hospital Euromedik

Belgrade, 11000, Serbia

Location

Institute of Mental Health

Belgrade, 11000, Serbia

Location

Special Hospital for Psychiatric Diseases "Kovin"

Kovin, 26220, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Vavrusova Consulting s.r.o. Psychiatricka ambulancia

Bratislava, 85101, Slovakia

Location

Investa spol. s.r.o., Kosice Psychiatricka ambulancia

Košice, 04001, Slovakia

Location

Psycholine s.r.0. Psychiatricka ambulancia

Rimavská Sobota, 97901, Slovakia

Location

Centrum zdravia R.B.K. Psychiatricka ambulancia

Svidník, 08901, Slovakia

Location

Crystal Comfort s.r.o. Psychiatricka ambulancia

Vranov nad Topľou, 09301, Slovakia

Location

Regional Psychoneurological Hospital #3, Department of Neurosis and Borderline States # 8

Ivano-Frankivsk, 76011, Ukraine

Location

State Institution Institue of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency sychiatry and Narcology

Kharkiv, 61068, Ukraine

Location

State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Borderline Psychiatry

Kharkiv, 61068, Ukraine

Location

CI Kherson Regional Psychiatric Hospital of Kherson Regional Council, Male Dep of Psychiatry #3, Female Dep of Psychiatry #10

Kherson, 73488, Ukraine

Location

Communal Institution (CI) of Kyiv Regional Council regional Psychiatric and Narcological Medical Assocation, Dep #10 (male), Dep #2 (female)

Kyiv, 08631, Ukraine

Location

Communal Institution Odesa regional Medical Center of Mental Health, Dep #6 (Male), Dep #12 (Female)

Odesa, 65006, Ukraine

Location

Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)

Odesa, 67513, Ukraine

Location

Communal Institution Cherkasy regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12

Smila, 20708, Ukraine

Location

Transcarpathian Regional Narcological Dispensary, Department of Psychiatry

Uzhhorod, 88000, Ukraine

Location

communal Institution Acad. O.I. Yushchenko Vinnytsia Regional Psychoneurological hosital, Male Deparmtent #14, Female Department #15, Vinnytsia M.I. Pyrogov National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with the Course of P

Vinnytsia, 21005, Ukraine

Location

Related Publications (2)

• Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.

  PMID: 39098761 DERIVED

• Hopkins SC, Wilkinson S, Corriveau TJ, Nishikawa H, Nakamichi K, Loebel A, Koblan KS. Discovery of Nonracemic Amisulpride to Maximize Benefit/Risk of 5-HT7 and D2 Receptor Antagonism for the Treatment of Mood Disorders. Clin Pharmacol Ther. 2021 Sep;110(3):808-815. doi: 10.1002/cpt.2282. Epub 2021 Jun 12.

  PMID: 33961287 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

ClinicalTrialDisclosure@sunovion.com

1-866-503-6351

Study Officials

• CNS Medical Director

  Sumitomo Pharma America, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: June 26, 2018
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: May 18, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
• 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.

Locations

PL (7); SE (7); UA (10); US (7); RU (10); SL (5); BU (6); JP (35)