Bipolar I depression MedDRA version: 19.0 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 100000004873
Conditions
Interventions
Product Name: LURASIDONE HCL
Product Code: SM-13496
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lurasidone
CAS Number: 367514-88-3
Current Sponsor code: SM-13946
Other descriptive nam
Sponsors
Sumitomo Dainippon Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study. If the patient is a minor at the time of consent, written consent should be obtained from a legally acceptable representative (guardian) in addition to the patient him/herself. 2) Outpatients aged 18 through 74 years at informed consent. 3) Patients with bipolar I disorder, most recent episode depressed, with or without rapid cycling disease course (= 4 episodes of mood disturbance but =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1) Patients who were diagnosed as having an Axis I or Axis II disorder (DSM-IV-TR criteria) other than bipolar I disorder that is the primary focus of treatment within 3 months prior to screening. 2) Patients with a score of = 4 on the MADRS item 10 (suicidal thoughts) at screening or baseline. 3) Patients with a “Yes” response to the Columbia-Suicide Severity Rating Scale (C-SSRS) item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) at screening (within 6 months prior to screening) or baseline. 4) Patients with imminent risk of suicide or injury to self, others, or property. 5) Patients for whom diagnostic agreement (based on the Bipolarity Index) between the investigator and Bracket (Pennsylvania, the United States), the agency for computerized diagnosis, cannot be reached. 6) Patients with a history of non-response to 6-week trial of 3 or more antidepressants (with or without concomitant use of mood stabilizers) during the current episode. 7) Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening. 8) Patients who received monoamine oxidase (MAO) inhibitor within 21 days prior to screening. 9) Patients who received fluoxetine or a combination of olanzapine and fluoxetine within 28 days prior to screening. 10) Patients who received any depot antipsychotics (sustained-release formulation) within 90 days prior to screening. 11) Patients who received clozapine within 120 days prior to screening. 12) Patients who received electroconvulsive therapy within 90 days prior to screening. 13) Patients with a = 25% reduction in the MADRS total score between screening and baseline. 14) Patients with a history of HIV seropositivity. 15) Patients with a history of alcohol/drug abuse (DSM-IV-TR criteria) within 3 months prior to screening or of alcohol/drug dependence (DSM-IV-TR criteria) within 12 months prior to screening. Exceptions include caffeine or nicotine abuse/dependency. 16) Patients with a history of hypersensitivity (eg, drug-induced anaphylaxis, rash, urticaria, or other allergic reactions) to more than one distinct chemical class of drug. 17) Patients with previous or existing clinically significant complications, such as serious nervous system, endocrine system (eg, type I diabetes mellitus), hepatic, renal, hematological, respiratory, cardiovascular (eg, unstable angina, congestive heart failure), gastrointestinal, urological, or other diseases. Patients who have a history of any of such diseases and who are considered ineligible for the study by the investigator. 18) Patients with acute hepatitis, severe chronic hepatitis or marked hepatic dysfunction. When the hepatitis screening test is positive, the investigator should evaluate carefully patient eligibility on the basis of his or her medical history or other laboratory data. 19) Patients with a gastrointestinal disease or a surgical history that may affect drug absorption, distribution, metabolism, or excretion. 20) Patients with any chronic organic disease of the central nervous system (ie, tumor, inflammation, convulsive seizure, vascular disorders, Parkinson’s disease, Alzheimer’s disease or other type of dementia, myasthenia gravis, or other degenerative diseases) . 21) Patients with any mental retardation or persistent neurological findings due to serious head injury. 22) Patients with a BMI of = 18 kg/m2 or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy of SM-13496 monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the Montgomery-?sberg Depression Rating Scale (MADRS) total score at Week 6. ;Secondary Objective: 1) To evaluate the efficacy of SM-13496 monotherapy in patients with depressive symptoms associated with bipolar I disorder 2) To evaluate the time course of efficacy of SM-13496 monotherapy in patients with depressive symptoms associated with bipolar I disorder 3) To evaluate the following - The efficacy for anxiety symptoms associated with bipolar I disorder by assessing the change from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) total score at Week 6 - The efficacy for manic symptoms associated with bipolar I disorder by assessing the change from baseline in the Young Mania Rating Scale (YMRS) total score at Week 6 4) To evaluate the overall safety of SM-13496 5) To evaluate the influence on the extrapyramidal symptoms 6) To evaluate the influence on the following - QTc - Body weight - Prolactin - Glucose metabolism - Lipid metabolism ;Primary end point(s): The primary variable of the study is the change from baseline in the MADRS total score at Week 6;Timepoint(s) of evaluation of this end point: Baseline, 1, 2, 3, 4, 5 and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in the MADRS total score at each assessment - Change from baseline in the CGI-BP-S (depression) score at Week 6 and each assessment point - Change from baseline in the SDS total score at Week 6 - Change from baseline in the YMRS total score at Week 6 and each assessment point - Change from baseline in the HAM-A total score at Week 6 - Treatment response rate (proportion of patients who achieve a = 50% reduction from baseline in the MADRS total score) at Week 6 - Symptom remission rate (proportion of patients who achieve a MADRS total score of = 12) at Week 6;Timepoint(s) of evaluation of this end point: Baseline, 1, 2, 3, 4, 5 and 6 weeks | — |
Countries
Japan, Lithuania, Malaysia, Philippines, Russian Federation, Slovakia, Taiwan, Ukraine
Contacts
Public ContactKantaro Ushiroda
Sumitomo Dainippon Pharma Co., Ltd.
Outcome results
None listed