First controlled treatment trial of bipolar II hypomania with mixed symptoms: quetiapine versus placebo.

Abstract

OBJECTIVES:

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: Trisha Suppes, Terence A Ketter, Iola S Gwizdowski, Ellen B Dennehy, Shelley J Hill, E Grace Fischer, Diane E Snow, Robert Gonzalez, Suresh Sureddi, Geetha Shivakumar, Victoria E Cosgrove
• Journal: Journal of affective disorders (J Affect Disord) Vol. 150 Issue 1 Pg. 37-43 (Aug 15 2013) ISSN: 1573-2517 [Electronic] Netherlands
• PMID: 23521871 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Published by Elsevier B.V.

Chemical References

• Antipsychotic Agents
• Dibenzothiazepines
• Placebos
• Quetiapine Fumarate

Topics

• Adolescent
• Adult
• Aged
• Antipsychotic Agents (adverse effects, therapeutic use)
• Bipolar Disorder (drug therapy, psychology)
• Dibenzothiazepines (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Placebos
• Quetiapine Fumarate
• Treatment Outcome
• Young Adult