title: A double-blind, placebo-controlled study of adjunctive calcitonin nasal spray in acute refractory mania.
abstract: OBJECTIVE
  Calcitonin, a neuropeptide, has been shown in preliminary double-blind trials to reduce agitation in patients with acute mania. Given that it has effects similar to those of lithium and anticonvulsants on modulation of second-messenger signaling pathways and stabilization of neuronal membranes, this study examined the efficacy of calcitonin nasal spray in treating acute manic symptoms in patients with treatment-resistant mania using a double-blind, placebo-controlled design.
  
  
  METHODS
  A total of 46 hospitalized patients experiencing either a manic or a mixed episode, who were refractory to treatment with adequate doses of either a mood stabilizer or an antipsychotic, or a mood stabilizer/antipsychotic combination, and had a score of ≥16 on the Young Mania Rating Scale (YMRS), were randomized to receive adjunctive nasal calcitonin 200 IU (n = 24) or saline (n = 22) spray for three weeks. The primary efficacy measure was the change in YMRS scores using the last observation carried forward (LOCF) method.
  
  
  RESULTS
  The clinical and demographic characteristics were similar between the groups. Patients had a mean YMRS score of 26 in the placebo group and a mean score of 25 in the calcitonin group. There were no significant differences in YMRS scores or percentage responders at three weeks between patients who received calcitonin and those who received placebo. There were also no significant differences in change scores on any other scales. Few patients experienced any adverse events.
  
  
  CONCLUSIONS
  This study does not support the use of nasal calcitonin in the treatment of treatment-resistant mania.
authors.affiliation: Department of Psychiatry, University of British Columbia, Vancouver, BC.
authors.forename: Astrid
authors.initials: A
authors.lastname: Vik
authors.forename: Arun
authors.initials: A
authors.lastname: Ravindran
authors.forename: I-Shin
authors.initials: IS
authors.lastname: Shiah
authors.forename: Hubert
authors.initials: H
authors.lastname: Wong
authors.forename: Nazlin
authors.initials: N
authors.lastname: Walji
authors.forename: Raymond W
authors.initials: RW
authors.lastname: Lam
authors.forename: Lakshmi N
authors.initials: LN
authors.lastname: Yatham
mesh_terms: D000328:Adult; D018692:Antimanic Agents / Q000008:administration & dosage; D001714:Bipolar Disorder / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D002116:Calcitonin / Q000008:administration & dosage*; D004311:Double-Blind Method; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000188:drug therapy / Q000209:etiology / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D018692:Antimanic Agents; D059085:Nasal Sprays; D002116:Calcitonin
keywords: bipolar disorder; calcitonin; nasal spray; refractory mania