title: Double-blind, randomized, placebo-controlled 6-week study on the efficacy and safety of the tamoxifen adjunctive to lithium in acute bipolar mania.
abstract: BACKGROUND
  Considerable amount of biochemical data supports the potential involvement of protein kinase C in the pathophysiology and treatment of bipolar disorder. The aim of this double-blind, placebo-controlled study was to investigate the efficacy and tolerability of tamoxifen as an adjunct to lithium for the treatment of acute mania in hospitalized bipolar patients.
  
  
  METHODS
  Eligible participants were 40 inpatients, between the ages of 19 and 49 years with current manic episode. Patients were randomly allocated to lithium (1-1.2 mEq/L) + tamoxifen 80 mg/day (group A) or lithium (1-1.2 mEq/L) + placebo (group B) for a 6-week, double-blind, placebo-controlled study. The principal measure of outcome was the Young Mania Rating Scale. The raters used standardized instructions for Young Mania Rating Scale.
  
  
  RESULTS
  Young Mania Rating Scale scores improved with tamoxifen. The difference between the two protocols was significant as indicated by the effect of the group, the between-subjects factor (F=5.41, df=1, p=0.02). A significant difference was observed on the Positive and Negative Syndrome Scale total score at week 6 in the two groups. The difference between the two groups in the frequency of side effects was not significant except for fatigue that occurred more often in the tamoxifen group.
  
  
  CONCLUSIONS
  Tamoxifen is an antagonist of estrogen receptor as well.
  
  
  CONCLUSIONS
  The results demonstrate that the combination of tamoxifen with lithium was superior to lithium alone for the rapid reduction of manic symptoms. The combined use of tamoxifen with lithium was well tolerated in these acutely manic patients.
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Zohreh
authors.initials: Z
authors.lastname: Amrollahi
authors.forename: Farzin
authors.initials: F
authors.lastname: Rezaei
authors.forename: Bahman
authors.initials: B
authors.lastname: Salehi
authors.forename: Amir-Hossein
authors.initials: AH
authors.lastname: Modabbernia
authors.forename: Azad
authors.initials: A
authors.lastname: Maroufi
authors.forename: Gholam-Reza
authors.initials: GR
authors.lastname: Esfandiari
authors.forename: Mehrangiz
authors.initials: M
authors.lastname: Naderi
authors.forename: Fariba
authors.initials: F
authors.lastname: Ghebleh
authors.forename: Seyed-Ali
authors.initials: SA
authors.lastname: Ahmadi-Abhari
authors.forename: Majid
authors.initials: M
authors.lastname: Sadeghi
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000328:Adult; D018692:Antimanic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D018020:Lithium Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018692:Antimanic Agents; D018020:Lithium Compounds; D013629:Tamoxifen