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

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

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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.

Original languageEnglish (US)
Pages (from-to)37-43
Number of pages7
JournalJournal of Affective Disorders
Volume150
Issue number1
DOIs
StatePublished - Aug 15 2013

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Placebos
Bipolar Disorder
Depression
Therapeutics
Diagnostic and Statistical Manual of Mental Disorders
Quetiapine Fumarate
Clinical Trials
Interviews
Safety

All Science Journal Classification (ASJC) codes

  • Clinical Psychology
  • Psychiatry and Mental health

Cite this

Suppes, T., Ketter, T. A., Gwizdowski, I. S., Dennehy, E. B., Hill, S. J., Fischer, E. G., ... Cosgrove, V. E. (2013). First controlled treatment trial of bipolar II hypomania with mixed symptoms: Quetiapine versus placebo. Journal of Affective Disorders, 150(1), 37-43. https://doi.org/10.1016/j.jad.2013.02.031
Suppes, Trisha ; Ketter, Terence A. ; Gwizdowski, Iola S. ; Dennehy, Ellen B. ; Hill, Shelley J. ; Fischer, E. Grace ; Snow, Diane E. ; Gonzalez, Robert ; Sureddi, Suresh ; Shivakumar, Geetha ; Cosgrove, Victoria E. / First controlled treatment trial of bipolar II hypomania with mixed symptoms : Quetiapine versus placebo. In: Journal of Affective Disorders. 2013 ; Vol. 150, No. 1. pp. 37-43.
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Suppes, T, Ketter, TA, Gwizdowski, IS, Dennehy, EB, Hill, SJ, Fischer, EG, Snow, DE, Gonzalez, R, Sureddi, S, Shivakumar, G & Cosgrove, VE 2013, 'First controlled treatment trial of bipolar II hypomania with mixed symptoms: Quetiapine versus placebo', Journal of Affective Disorders, vol. 150, no. 1, pp. 37-43. https://doi.org/10.1016/j.jad.2013.02.031

First controlled treatment trial of bipolar II hypomania with mixed symptoms : Quetiapine versus placebo. / Suppes, Trisha; Ketter, Terence A.; Gwizdowski, Iola S.; Dennehy, Ellen B.; Hill, Shelley J.; Fischer, E. Grace; Snow, Diane E.; Gonzalez, Robert; Sureddi, Suresh; Shivakumar, Geetha; Cosgrove, Victoria E.

In: Journal of Affective Disorders, Vol. 150, No. 1, 15.08.2013, p. 37-43.

Research output: Contribution to journalArticle

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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.

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.

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