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 as a maintenance treatment based on independent clinical judgment of treating physician.2 Patients with bipolar type I disorder (bipolar I mood spectrum) from mania with or without depressive symptoms to depression with or without manic symptoms.3 Patients with the complete and relevant medical records available.4 Participants and their legally-acceptable representative must sign 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Exclusion criteria: A patient will be withdrawn from data collection within the study for any of the following reasons: -Lost to follow-up -Withdrawal of consent -Death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 maintenance treatment in patients of bipolar I mood spectrum, from mania with or without depressive symptoms to depression with or without manic symptoms.Timepoint: - The proportion of patients who will experience a relapse episode (manic, hypomanic, depressive, mixed) during first 3 months and 6 months after the acute mood episode or in case of relapse occurrence. - Proportion of patient achieving remission as per YMRS score (less than 10) at each post-baseline visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate the safety of endoxifen maintenance treatment in patients of 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 maintenance treatment in patients of 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 post-baseline in total YMRS (Young Mania Rating Scale) score. - Mean change from baseline to each subsequent visit in clinical global impression (CGI)2 score. - Percentage of patients needing lorazepam /clonazepam for controlling acute agitation/akathisia. - Percentage of patients requiring rescue medications | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd.
Outcome results
None listed