title: Endoxifen, a New Treatment Option for Mania: A Double-Blind, Active-Controlled Trial Demonstrates the Antimanic Efficacy of Endoxifen.
abstract: 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.
authors.affiliation: Jina Pharmaceuticals Inc, Libertyville, Illinois, USA.
authors.forename: A
authors.initials: A
authors.lastname: Ahmad
authors.affiliation: Jina Pharmaceuticals Inc, Libertyville, Illinois, USA.
authors.forename: S
authors.initials: S
authors.lastname: Sheikh
authors.affiliation: Divyam Hospital, Surat, GJ, India.
authors.forename: T
authors.initials: T
authors.lastname: Shah
authors.affiliation: Asha Hospital, Hyderabad, AP, India.
authors.forename: M S
authors.initials: MS
authors.lastname: Reddy
authors.affiliation: Sujata Birla Hospital and Medical Research Centre, Nashik, MH, India.
authors.forename: Bsv
authors.initials: B
authors.lastname: Prasad
authors.affiliation: S. P. Medical College & A G Hospitals, Bikaner, RJ, India.
authors.forename: K K
authors.initials: KK
authors.lastname: Verma
authors.affiliation: Shri Hatkesh Healthcare Foundation, Junagadh, GJ, India.
authors.forename: B B
authors.initials: BB
authors.lastname: Chandrakant
authors.affiliation: Intas Pharmaceuticals Ltd, Ahmedabad, GJ, India.
authors.forename: M
authors.initials: M
authors.lastname: Paithankar
authors.affiliation: Lambda Therapeutic Research Ltd, Ahmedabad, GJ, India.
authors.forename: P
authors.initials: P
authors.lastname: Kale
authors.affiliation: Lambda Therapeutic Research Ltd, Ahmedabad, GJ, India.
authors.forename: R V
authors.initials: RV
authors.lastname: Solanki
authors.affiliation: Lambda Therapeutic Research Ltd, Ahmedabad, GJ, India.
authors.forename: R
authors.initials: R
authors.lastname: Patel
authors.affiliation: Intas Pharmaceuticals Ltd, Ahmedabad, GJ, India.
authors.forename: H
authors.initials: H
authors.lastname: Barkate
authors.affiliation: Jina Pharmaceuticals Inc, Libertyville, Illinois, USA.
authors.forename: I
authors.initials: I
authors.lastname: Ahmad