Health Condition 1: F316- Bipolar disorder, current episodemixed
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Dr G Prasad Rao
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients, aged 18 years or older at time of initiation of endoxifen treatment as per approved prescribing information based on independent clinical judgment of treating physician 2. Patients with bipolar I disorder (bipolar I mood spectrum) from mania with or without depressive symptoms to depression with or without manic symptoms. 3. Patients whose comorbid conditions are stable according to investigator 4. must sign and their legally-acceptable representative must sign a /ICF allowing data collection and source data verification in accordance with local requirements
Exclusion criteria
Exclusion criteria: A patient will be withdrawn from data collection within the study for any of the following reasons - Lost to follow-up - Withdrawal of consent - Death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the efficacy of endoxifen for the treatment of bipolar I disorder (bipolar I mood spectrum) from mania with or without depressive symptoms to depression with or without manic symptomsTimepoint: Patients achieving remission within 42 days of treatment based on change in the Young Mania Rating Scale (YMRS) total score (greater than or equal to 50 percent decrease from baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate other efficacy parameters of endoxifen for the treatment of bipolar I disorder (bipolar I mood spectrum) from mania with or without depressive symptoms to depression with or without manic symptoms.Timepoint: - Change in clinical global impression (CGI) score greater than or equal to 2 points from baseline within 42 days of treatment - Percentage of patients needing lorazepam/ clonazepam for controlling acute agitation/akathisia. - Percentage of patients requiring rescue medications. - Mean change from baseline to within 42 days of treatment in Montgomery-Asberg Depression Rating Scale (MADRS) score. ;The secondary objective is to evaluate the safety of endoxifen for the treatment of bipolar I disorder (bipolar I mood spectrum) from mania with or without depressive symptoms to depression with or without manic symptoms.Timepoint: All treatment related adverse events including abnormal laboratory parameters;To evaluate other efficacy parameters of endoxifen for the treatment of bipolar I disorder (bipolar I mood spectrum) from mania with or without depressive symptoms to depression with or without manic symptoms.Timepoint: - Mean change from baseline to each subsequent visit in total YMRS (Young Mania Rating Scale) score. - Time to achieving remission (reduction in YMRS greater than 50 percent) - Proportion of patient achieving remission as per YMRS score (less than or equal to 9) at each post-baseline visit (if increase in YMRS score greater than 10-20 percent of baseline, mild to moderate relapse) | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd.
Outcome results
None listed