Bipolar I disorder.
Conditions
Interventions
investigational material(s)
Generic name etc : SM-13496 (lurasidone HCl)
INN of investigational material : Lurasidone
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for
Sponsors
Sumitomo Dainippon Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who completed the prior placebo controlled study -Patients who completed the prior study and who are considered by the investigator to be eligible and without safety concerns. Patients who did not participate in the prior placebo controlled study -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. -Patients aged 18 through 74 years at the time of consent -Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode manic, hypomanic, or mixed with or without rapid cycling disease course (>=4 episodes of mood disturbance, but < 8 episodes in the previous 12 months prior to screening) etc.
Exclusion criteria
Exclusion criteria: - Patients with imminent risk of suicide or injury to self, others, or property. - Patients who are otherwise considered ineligible for the study by the investigator. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Incidence of adverse events (AEs) and adverse drug reactions (ADRs) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy -Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) score at the final assessment and each assessment point -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 at each assessment point -Time to recurrence/relapse of any mood event from clinical stability of bipolar disorder, and etc. | — |
Countries
Asia except Japan, Europe, Japan
Outcome results
None listed