TY - JOUR
T1 - First controlled treatment trial of bipolar II hypomania with mixed symptoms
T2 - Quetiapine versus placebo
AU - Suppes, Trisha
AU - Ketter, Terence A.
AU - Gwizdowski, Iola S.
AU - Dennehy, Ellen B.
AU - Hill, Shelley J.
AU - Fischer, E. Grace
AU - Snow, Diane E.
AU - Gonzalez, Robert
AU - Sureddi, Suresh
AU - Shivakumar, Geetha
AU - Cosgrove, Victoria E.
N1 - Funding Information:
This project was supported by AstraZeneca Pharmaceuticals ( ISS0333 ). We thank Natalie Feldman, A.B. who assisted with the preparation and proof-reading of the manuscript.
PY - 2013/8/15
Y1 - 2013/8/15
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jad.2013.02.031
DO - 10.1016/j.jad.2013.02.031
M3 - Article
C2 - 23521871
AN - SCOPUS:84880919610
SN - 0165-0327
VL - 150
SP - 37
EP - 43
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
IS - 1
ER -