title: First controlled treatment trial of bipolar II hypomania with mixed symptoms: quetiapine versus placebo.
abstract: OBJECTIVE
  To compare the efficacy and safety of adjunctive quetiapine (QTP) versus placebo (PBO) for patients with bipolar II disorder (BDII) currently experiencing mixed hypomanic symptoms in a 2-site, randomized, placebo-controlled, double-blind, 8-week investigation.
  
  
  METHODS
  Participants included 55 adults (age 18-65 years) who met criteria for BDII on the Structured Clinical Interview for DSM-IV-TR (SCID). Entrance criteria included a stable medication regimen for ≥2 weeks and hypomania with mixed symptoms (>12 on the Young Mania Rating Scale [YMRS] and >15 on the Montgomery Asberg Depression Rating Scale [MADRS] at two consecutive visits 1-3 days apart). Participants were randomly assigned to receive adjunctive quetiapine (n=30) or placebo (n=25).
  
  
  RESULTS
  Adjunctive quetiapine demonstrated significantly greater improvement than placebo in Clinical Global Impression for Bipolar Disorder Overall Severity scores (F(1)=10.12, p=.002) and MADRS scores (F(1)=6.93, p=.0138), but no significant differences were observed for YMRS scores (F(1)=3.68, p=.069). Side effects of quetiapine were consistent with those observed in previous clinical trials, with sedation/somnolence being the most common, occurring in 53.3% with QTP and 20.0% with PBO.
  
  
  CONCLUSIONS
  While QTP was significantly more effective than PBO for overall and depressive symptoms of BDII, there was no significant difference between groups in reducing symptoms of hypomania. Hypomania improved across both groups throughout the study.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Stanford University, School of Medicine, Stanford, CA, USA. tsuppes@stanford.edu
authors.forename: Trisha
authors.initials: T
authors.lastname: Suppes
authors.forename: Terence A
authors.initials: TA
authors.lastname: Ketter
authors.forename: Iola S
authors.initials: IS
authors.lastname: Gwizdowski
authors.forename: Ellen B
authors.initials: EB
authors.lastname: Dennehy
authors.forename: Shelley J
authors.initials: SJ
authors.lastname: Hill
authors.forename: E Grace
authors.initials: EG
authors.lastname: Fischer
authors.forename: Diane E
authors.initials: DE
authors.lastname: Snow
authors.forename: Robert
authors.initials: R
authors.lastname: Gonzalez
authors.forename: Suresh
authors.initials: S
authors.lastname: Sureddi
authors.forename: Geetha
authors.initials: G
authors.lastname: Shivakumar
authors.forename: Victoria E
authors.initials: VE
authors.lastname: Cosgrove
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D003987:Dibenzothiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D000069348:Quetiapine Fumarate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D010919:Placebos; D000069348:Quetiapine Fumarate
keywords: Bipolar II disorder; Bipolar disorder; Hypomania with mixed symptoms; Mixed features; Quetiapine; Treatment