Endoxifen monotherapy in patients with Bipolar Affective disorder
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Reduction of YMRS scores
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •The study will include male and female patients aged between 18-65 years who have diagnosed with bipolar Affective Disorder.
- •Participants must be willing to provide informed consent and should be accompoanied by atleast one first-degree relative who also consents to participate.
- •Only those patients who have no prior history of any other diagnosed psychiatric illnesses and have received any previous illnesses and have not recieved any previous psychiatric treatment will be included in the study.
Exclusion Criteria
- •Patients with comorbid medical conditions, including hepatic, renal, gastroenterological, respiratory, cardiovascular or hematological diseases, as identifies through clinical history and examination will be excluded from the study.
- •Additionally, individuals with comorbid psychiatric illnesses, pregnant or lactating women and patients with deranged glomerular filtration rate (GFR) will also be excluded from participation.
Outcomes
Primary Outcomes
Reduction of YMRS scores
Time Frame: 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Abhinav Dhankar
School of Mdical sciences and research,Sharda Hospital,Gr.Nooida,UP