A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depressio
- Conditions
- major depressive episodes associated with bipolar I disorder
- Registration Number
- JPRN-jRCT2080224715
- Lead Sponsor
- Sunovion Pharmaceuticals Inc. / Sumitomo Dainippon Pharma Co.,Ltd.(Japan)
- Brief Summary
The overall results of this study support proof of concept of SEP 4199 for reducing depression symptoms in bipolar depression, with evidence of a favorable efficacy and tolerability at both 200 mg and 400 mg doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 344
1.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 (more than or equal to 4 episodes of mood disturbance but less than 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.
2.Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.
3.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.
4.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.
5.Subject's current major depressive episode is more than or equal to 4 weeks and less than 12 months in duration at Screening.
6.Subject has a MADRS total score more than or equal to 22 at both Screening and Baseline.
7.Subject has a YMRS total score less than or equal to 12 at Screening.
8.Female subjects of childbearing potential must have a negative serum B- hCG test at Screening.
9.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.
10.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.
11.Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
12.Subjects with type 2 diabetes are eligible for study inclusion only if all of the following conditions are met within 30 days prior to Screening:
Subject's random screening glucose is < 200 mg/ dL (11.1 mmol /L).
Subject's Hemoglobin A1c (HbA1c) less than or equal to 7.0%.
If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 30 days prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.
Subject has not required hospitalization for diabetes or related complications in the past 12 months.
Note: Subjects with type 2 diabetes that is newly diagnosed during screening are ineligible for the study.
13.Subject who requires concomitant medication treatment with the following agents may be included if they have been on stable doses for the specified times:
1)oral hypoglycemics must be stabilized for at least 30 days prior to baseline;
2)thyroid hormone replacement must be stable for at least 90 days prior to baseline;
3)anti hypertensive agents must be stable for at least 30 days prior to baseline. The subject's medical condition should be deemed clinically stable following consultation with the M
1. Subject has a lifelong history or presence of symptoms consistent with a major psychiatric disorder other than bipolar I disorder as defined by DSM 5. Exclusionary disorders include but are not limited to moderate to severe alcohol use disorder (within past 12 months), substance use disorder (other than nicotine or caffeine) within past 12 months, bipolar II disorder, schizoaffective disorder, obsessive compulsive disorder, posttraumatic stress disorder.
2. Subject demonstrates a decrease (improvement) of more than or equal to 25% in MADRS total score from Screening to Baseline, or subject's MADRS total score is less than 22 at Baseline.
3. 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.
4. 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.
Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if under control) must be discussed with the Medical Monitor before being randomized in the study.
Subject has evidence of any chronic organic disease of the CNS such as tumors, inflammation, active (or history of) seizure disorder, vascular disorder, Parkinson's disease, Alzheimer's disease or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, subjects must not have a history of intellectual disability or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, is not exclusionary.
Subject has a history of malignancy less than 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 hi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6
- Secondary Outcome Measures
Name Time Method efficacy<br>Change from baseline in global severity assessed by the Clinical Global Impressions - Severity: Bipolar Version (CGI-BP-S) score (depression) at Week 6