1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [dr.abhinavdhankar77@gmail.com].
   


6. For how long will this data be available start date provided 25-06-2025 and end date provided 25-06-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

This research study is being conducted at the School of Medical Sciences & Research and Sharda Hospital, Greater Noida. The study focuses on newly admitted patients from the Psychiatry Department’s inpatient unit who meet specific inclusion and exclusion criteria. The primary objective is to evaluate the efficacy of endoxifen 8 mg once daily in managing acute mania among patients diagnosed with bipolar affective disorder. Eligible participants will undergo a detailed clinical evaluation, including a thorough medical and psychiatric history, with particular attention to past episodes of bipolar disorder. Each participant will receive a patient information sheet, and the study procedures will be clearly explained to both the patient and at least one caregiver. Informed consent will be obtained prior to inclusion in the study. At baseline, all patients will be assessed using the Young Mania Rating Scale (YMRS) to determine the severity of mania. They will then be started on endoxifen 8 mg OD and re-evaluated using the YMRS at regular intervals for up to eight weeks to monitor changes in manic symptoms. A total of 60 patients will be included in the study, all of whom will follow the same protocol. The inclusion criteria for participation include male and female patients aged 18 to 65 years, those diagnosed with bipolar affective disorder, individuals willing to provide informed consent along with at least one first-degree relative, and those with no prior psychiatric diagnosis or treatment. The exclusion criteria include patients with medical comorbidities such as hepatic, renal, gastrointestinal, respiratory, cardiovascular, or hematologic disorders based on history and examination, those with comorbid psychiatric illnesses, and pregnant or lactating women. This study is expected to contribute valuable clinical data on the potential role of endoxifen in the treatment of acute manic episodes in bipolar disorder, providing further insights into its efficacy and safety profile.