title: Oral scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the antidepressant effect of oral scopolamine as an adjunct to citalopram.
  
  
  METHODS
  In this randomized double-blind placebo-controlled study, patients were assessed in the outpatient clinics of 2 large hospitals from November 2011 to January 2012. Forty patients (18-55 years) with major depressive disorder (DSM-IV-TR criteria) and 17-Item Hamilton Depression Rating Scale (HDRS) score ≥ 22 were randomly assigned to scopolamine hydrobromide (1 mg/d) (n = 20) or placebo (n = 20) in addition to citalopram for 6 weeks. HDRS score was measured at baseline and days 4, 7, 14, 28, and 42. The primary outcome measure was HDRS score change from baseline to week 6 in the scopolamine group versus the placebo group. Response was defined as ≥ 50% decrease in HDRS score; remission, as HDRS score ≤ 7.
  
  
  RESULTS
  Augmentation with scopolamine was significantly more effective than placebo (F(1,38) = 5.831, P = .021). Patients receiving scopolamine showed higher rates of response (65%, 13/20 at week 4) and remission (65%, 13/20 at week 6) than the placebo group (30%, 6/20 and 20%, 4/20, respectively; P = .027, P = .004, respectively). Patients in the scopolamine group showed higher rates of dry mouth, blurred vision, and dizziness than the placebo group.
  
  
  CONCLUSIONS
  Oral scopolamine is a safe and effective adjunct for treatment of patients with moderate to severe major depressive disorder.
  
  
  BACKGROUND
  Iranian Registry of Clinical Trials identifier: IRCT201201181556N31.
authors.affiliation: Psychiatric Research Centre, Roozbeh Hospital, Tehran, Iran.
authors.forename: Danial
authors.initials: D
authors.lastname: Khajavi
authors.forename: Mehdi
authors.initials: M
authors.lastname: Farokhnia
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Modabbernia
authors.forename: Mandana
authors.initials: M
authors.lastname: Ashrafi
authors.forename: Seyed-Hesammedin
authors.initials: SH
authors.lastname: Abbasi
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D057189:Checklist; D018680:Cholinergic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007492:Iran; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory / Q000706:statistics & numerical data; D011594:Psychometrics; D012601:Scopolamine / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D018680:Cholinergic Antagonists; D015283:Citalopram; D012601:Scopolamine