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Effect of Endoxifen in Bipolar Affective disorder(BPAD).

Endoxifen monotherapy in patients with Bipolar Affective disorder

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089315
Enrollment
60
Registered
2025-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F31- Bipolar disorder

Interventions

Intervention1: Endoxifen monotherapy, NOT APPLICABLE FOR COMPARATOR AGENT: Endoxifen will be given to BPAD patients coming in acute mania phase and then effect will be assessed via Young Mania Rating

Sponsors

School of Medical Sciences and Reseearch and Sharda Hospital Greater Noida
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Reduction of YMRS scoresTimepoint: 8 weeks

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactAbhinav Dhankar

School of Mdical sciences and research,Sharda Hospital,Gr.Nooida,UP

kunal.kumar@gmail.com7827288403

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026