Open AccessEndoxifen, a New Treatment Option for Mania: A Double‐Blind, Active‐Controlled Trial Demonstrates the Antimanic Efficacy of Endoxifen
Author(s) -
Ahmad A,
Sheikh S,
Shah T,
Reddy MS,
Prasad BSV,
Verma KK,
Chandrakant BB,
Paithankar M,
Kale P,
Solanki RV,
Patel R,
Barkate H,
Ahmad I
Publication year - 2016
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12407
Subject(s) - mania , bipolar disorder , medicine , bipolar i disorder , mood , mood stabilizer , young mania rating scale , treatment of bipolar disorder , pharmacology , psychiatry
The protein kinase C (PKC) signaling system plays a role in mood disorders and PKC inhibitors such as endoxifen may be an innovative medicine for bipolar disorder (BP) patients. In this study we show for the first time the antimanic properties of endoxifen in patients with bipolar I disorder (BPD I) with current manic or mixed episode. In a double‐blind, active‐controlled study, 84 subjects with BPD I were randomly assigned to receive endoxifen (4 mg/day or 8 mg/day) or divalproex in a 2:1 ratio. Patients orally administered 4 mg/day or 8 mg/day endoxifen showed significant improvement in mania assessed by the Young Mania Rating Scale as early as 4 days. The effect remained significant throughout the 21‐day period. At study end point, response rates were 44.44% and 64.29% at 4 mg/day and 8 mg/day of endoxifen treatment, respectively. Thus, endoxifen has been shown as a promising novel antimanic or mood stabilizing agent.