A study of endoxifen in patients

Not Applicable

• Conditions: Health Condition 1: F316- Bipolar disorder, current episodemixed

• Registration Number: CTRI/2021/09/036423
• Lead Sponsor: Dr G Prasad Rao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

A patient will be withdrawn from data collection within the study for any of the following reasons: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

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>- Proportion of patient achieving remission as per YMRS score (less than 10) at each post-baseline visit. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>- Mean change from baseline to each subsequent visit in clinical global impression (CGI)2 score. <br/ ><br>- Percentage of patients needing lorazepam /clonazepam for controlling acute agitation/akathisia. <br/ ><br>- Percentage of patients requiring rescue medications <br/ ><br>