Bipolar I Depression
Conditions
Brief summary
The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
Detailed description
The primary objective is to compare the efficacy of lurasidone (20-120 mg/day) monotherapy with that of placebo in patients with Bipolar I Depression by assessing the change from baseline in the MADRS total score at Week 6.
Interventions
DRUGLurasidone HCl
Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8.
DRUGPlacebo
Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
Sponsors
Sumitomo Pharma America, Inc.
Sumitomo Pharma (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who have provided written voluntary consent in person after receiving and understanding adequate explanation about the study, including the objectives, content, expected therapeutic and pharmacological effects, and risks. 2. Outpatients who are aged 18 through 65 years at time of informed consent. 3. Patients with bipolar I disorder, most recent episode depressed, without rapid cycling disease course ( no less than 4 episodes of mood disturbance in the 12 months prior to screening), and without psychotic features (diagnosed by DSM-5 criteria).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the MADRS total score at Week 6 | Baseline/ week 6 | Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the CGI-BP-S (depression) score at Week 6 | Baseline/ week 6 | Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the SDS total score at Week 6 | Baseline/ week 6 | Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of functional impairment in work/school, social life and family life/home responsibilities. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items. |
| Change from baseline in the YMRS total score at Week 6 and each assessment point | Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6 | YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items. |
| Change from baseline in the MADRS total score at each assessment point | Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6 | Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items. |
| Incidence of Adverse events (AEs) and Adverse drug reactions (ADRs) | Screening/ Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6/ Follow up | Adverse events, adverse drug reactions |
| Change from baseline in the HAM-A total score at Week 6 | Baseline/ week 6 | The Hamilton Rating Scale for Anxiety (HAM-A) scale is a rating scale developed to quantify the severity of anxiety symptomatology. The HAM-A total score ranges from a minimum of 0 to a maximum of 56. For the HAM-A total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The HAM-A contains fourteen (14) items. The total score is computed as the sum of the scores for the 14 items. |
| Change from baseline in the CGI-BP-S (depression) score at each assessment point | Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6 | Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. |
Countries
China
Outcome results
None listed