Bipolar I Disorder
Conditions
Brief summary
Mean change from baseline to Day 21 on the YMRS Total Score.
Detailed description
Percentage of patients with improvement of ≥ 50% in total YMRS from baseline., Clinical Global Impression-Bipolar (CGI-BP) score at the end of study., Mean change from baseline to the end of treatment (Day 21) in Montgomery-Åsberg Depression Rating Scale (MADRS) total score., Improvement in Clinical Global Impression-Severity of Illness scale (CGI-S) score., Columbia-Suicide Severity Rating Scale (C-SSRS) score at the end of treatment (Day 21)., Percentage of patients needing lorazepam/diazepam for controlling acute agitation/akathisia., Percentage of patients requiring rescue medications and withdrawal from the study., To evaluate trough concentrations of Endoxifen.
Interventions
DRUGEndoxifen
DRUGIdentical placebo tablets of Endoxifen manufactured by Intas Pharmaceuticals Limited
DRUGIndia. The placebo tablets were manufactured using the same excipients and the manufacturing process of endoxifen tablets. Like endoxifen 8 mg tablets
DRUGthe placebo tablets are green coloured
DRUGround shape
DRUGbiconvex
DRUGenteric coated tablets plain on both sides. The placebo for Endoxifen Tablets 8 mg was manufactured following the same procedure as the drug product without using endoxifen citrate.
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to Day 21 on the YMRS Total Score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with improvement of ≥ 50% in total YMRS from baseline., Clinical Global Impression-Bipolar (CGI-BP) score at the end of study., Mean change from baseline to the end of treatment (Day 21) in Montgomery-Åsberg Depression Rating Scale (MADRS) total score., Improvement in Clinical Global Impression-Severity of Illness scale (CGI-S) score., Columbia-Suicide Severity Rating Scale (C-SSRS) score at the end of treatment (Day 21)., Percentage of patients needing lorazepam/diazepam for controlling acute agitation/akathisia., Percentage of patients requiring rescue medications and withdrawal from the study., To evaluate trough concentrations of Endoxifen. | — |
Countries
Romania
Outcome results
None listed