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-13496
Other descriptive nam
Sponsors
Sumitomo Dainippon Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who completed the prior study D1002001: 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) Patients who completed the prior study and who are considered by the investigator to be eligible and without safety concerns 3) Patients who agree to use appropriate contraception to prevent pregnancy in female patients or the female partners of patients, when the patients or their partners are of childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 385 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients who completed the prior study: 1) Patients with a score > 4 on the Montgomery-?sberg Depression Rating Scale (MADRS) item 10 (suicidal thoughts) at Week 6 in the prior study 2) 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 a specific plan) or item 5 (active suicidal ideation with specific plan and intent) at Week 6 in the prior study 3) Patients with imminent risk of suicide or injury to self, others, or property 4) Patients who are otherwise considered ineligible for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): SAFETY ENDPOINTS: - Incidence of adverse events (AEs) and adverse drug reactions (ADRs) - Incidence of extrapyramidal AEs and ADRs - Proportion of patients with concomitant use of antiparkinson medication - Change from baseline in the prior study (D1002001) and the present study (D1002002) in the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) total score (except for the overall severity score) at the final assessment and at each assessment point - Change from baseline in the prior study and the present study in the individual DIEPSS symptoms scores at the final assessment and at each assessment - Change from baseline in the prior study and the present study in the serum prolactin concentration at the final assessment and at each assessment point - Change from baseline in the prior study and the present study in the ECG parameter (QTc) at the final measurement - Change from baseline in the prior study and the present study in the fasting blood glucose, HbA1c (NGSP), glycoalbumin, total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides at the final measurement - Change from baseline in the prior study and the present study in the body weight at the final measurement - Laboratory measures and vital signs - Proportion of patients with any instance of suicide attempt or suicidal ideation based on the Columbia Suicide Severity Rating Scale (C-SSRS) EFFICACY ENDPOINTS: 1) Change from baseline in the prior study (D1002001) and the present study (D1002002) in the MADRS total score at the final assessment and each assessment point 2) Change from baseline in the prior study and the present study in the Young Mania Rating Scale (YMRS) total score at the final assessment and each assessment point 3) Change from baseline in the prior study and the present study in the Clinical Global Impressions: Bipolar Version - Severity of Illness (CGI-BP-S) (overall, depression, mania) scores at the final assessment and each assessment point 4) Ch | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No;Timepoint(s) of evaluation of this end point: No | — |
Countries
Japan, Lithuania, Malaysia, Philippines, Russian Federation, Taiwan, Ukraine
Contacts
Public ContactKantaro Ushiroda
Sumitomo Dainippon Pharma Co., Ltd.
Outcome results
None listed