Quetiapine monotherapy in the treatment of patients with bipolar I or II depression and a rapid-cycling disease course: A randomized, double-blind, placebo-controlled study

Eduard Vieta, J. R. Calabrese, J. M. Goikolea, S. Raines, W. Macfadden, Mohammed Alam, Valerie Arnold, Charles Bailey, Guy Brannon, David Brown, Joseph Calabrese, John Carman, Andrew Cutler, Bernadette D'Souza, Naresh Emmanuel, Lawrence Ginsberg, Ram Gopalan, William Granger, Laszlo Gyulai, Howard HassmanSaul Helfing, George Joseph, Paul Keck, Terrence Ketter, Arif Khan, Ari Kiev, Irving Kolin, James Knutson, Michael Levy, H. E. Logue, David Marks, Greg Mattingly, Charles Merideth, Janice Miller, Dennis Munjack, William Privitera, Fred Reimherr, Robert Riesenberg, Leon Rosenberg, Leon Rubenfaer, David Sack, Abbey Strauss, David Walling, Richard Weisler

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Abstract

Objectives: To investigate the efficacy and tolerability of quetiapine monotherapy in patients with bipolar I or II disorder with a rapid-cycling disease course. Methods: Adult patients with a DSM-IV diagnosis of bipolar disorder, most recent episode depressed, with a rapid-cycling disease course from a previously completed multicenter trial randomized to 8 weeks of treatment with quetiapine 600 mg/day (n=31), quetiapine 300 mg/day (n=42), or placebo (n=35) were included in this sub-analysis. The primary efficacy variable was change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Results: Quetiapine (600 and 300 mg/day) provided significantly greater mean reductions from baseline to week 8 in the MADRS total score than placebo (-21.1, -20.7 versus -11.6, both p<0.001) in this patient population. Effect sizes in patients with a rapid-cycling disease course were 1.2 (600 mg/day) and 1.1 (300 mg/day) and were similar for bipolar I (0.98 and 1.22) and bipolar II (1.45 and 0.97) sub-groups. Significant improvements were also noted on the Clinical Global Impression, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Pittsburgh Sleep Quality Index, and Quality of Life Enjoyment and Satisfaction Questionnaire scales. Quetiapine was generally well tolerated with moderate increases in weight and extrapyramidal side effects compared to placebo. The incidence of treatment-emergent mania was similar to placebo. Conclusions: Quetiapine monotherapy (600 or 300 mg/day) is clinically effective and well tolerated in the short-term treatment of depressive episodes in patients with bipolar I or II disorder who have a rapid-cycling disease course.

Original languageEnglish (US)
Pages (from-to)413-425
Number of pages13
JournalBipolar Disorders
Volume9
Issue number4
DOIs
StatePublished - Jun 1 2007

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Placebos
Depression
Bipolar Disorder
Therapeutics
Diagnostic and Statistical Manual of Mental Disorders
Multicenter Studies
Quetiapine Fumarate
Sleep
Anxiety
Quality of Life
Weights and Measures
Incidence
Population

All Science Journal Classification (ASJC) codes

  • Psychiatry and Mental health
  • Biological Psychiatry

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Quetiapine monotherapy in the treatment of patients with bipolar I or II depression and a rapid-cycling disease course : A randomized, double-blind, placebo-controlled study. / Vieta, Eduard; Calabrese, J. R.; Goikolea, J. M.; Raines, S.; Macfadden, W.; Alam, Mohammed; Arnold, Valerie; Bailey, Charles; Brannon, Guy; Brown, David; Calabrese, Joseph; Carman, John; Cutler, Andrew; D'Souza, Bernadette; Emmanuel, Naresh; Ginsberg, Lawrence; Gopalan, Ram; Granger, William; Gyulai, Laszlo; Hassman, Howard; Helfing, Saul; Joseph, George; Keck, Paul; Ketter, Terrence; Khan, Arif; Kiev, Ari; Kolin, Irving; Knutson, James; Levy, Michael; Logue, H. E.; Marks, David; Mattingly, Greg; Merideth, Charles; Miller, Janice; Munjack, Dennis; Privitera, William; Reimherr, Fred; Riesenberg, Robert; Rosenberg, Leon; Rubenfaer, Leon; Sack, David; Strauss, Abbey; Walling, David; Weisler, Richard.

In: Bipolar Disorders, Vol. 9, No. 4, 01.06.2007, p. 413-425.

Research output: Contribution to journalArticle

Vieta, E, Calabrese, JR, Goikolea, JM, Raines, S, Macfadden, W, Alam, M, Arnold, V, Bailey, C, Brannon, G, Brown, D, Calabrese, J, Carman, J, Cutler, A, D'Souza, B, Emmanuel, N, Ginsberg, L, Gopalan, R, Granger, W, Gyulai, L, Hassman, H, Helfing, S, Joseph, G, Keck, P, Ketter, T, Khan, A, Kiev, A, Kolin, I, Knutson, J, Levy, M, Logue, HE, Marks, D, Mattingly, G, Merideth, C, Miller, J, Munjack, D, Privitera, W, Reimherr, F, Riesenberg, R, Rosenberg, L, Rubenfaer, L, Sack, D, Strauss, A, Walling, D & Weisler, R 2007, 'Quetiapine monotherapy in the treatment of patients with bipolar I or II depression and a rapid-cycling disease course: A randomized, double-blind, placebo-controlled study', Bipolar Disorders, vol. 9, no. 4, pp. 413-425. https://doi.org/10.1111/j.1399-5618.2007.00479.x
Vieta, Eduard ; Calabrese, J. R. ; Goikolea, J. M. ; Raines, S. ; Macfadden, W. ; Alam, Mohammed ; Arnold, Valerie ; Bailey, Charles ; Brannon, Guy ; Brown, David ; Calabrese, Joseph ; Carman, John ; Cutler, Andrew ; D'Souza, Bernadette ; Emmanuel, Naresh ; Ginsberg, Lawrence ; Gopalan, Ram ; Granger, William ; Gyulai, Laszlo ; Hassman, Howard ; Helfing, Saul ; Joseph, George ; Keck, Paul ; Ketter, Terrence ; Khan, Arif ; Kiev, Ari ; Kolin, Irving ; Knutson, James ; Levy, Michael ; Logue, H. E. ; Marks, David ; Mattingly, Greg ; Merideth, Charles ; Miller, Janice ; Munjack, Dennis ; Privitera, William ; Reimherr, Fred ; Riesenberg, Robert ; Rosenberg, Leon ; Rubenfaer, Leon ; Sack, David ; Strauss, Abbey ; Walling, David ; Weisler, Richard. / Quetiapine monotherapy in the treatment of patients with bipolar I or II depression and a rapid-cycling disease course : A randomized, double-blind, placebo-controlled study. In: Bipolar Disorders. 2007 ; Vol. 9, No. 4. pp. 413-425.
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abstract = "Objectives: To investigate the efficacy and tolerability of quetiapine monotherapy in patients with bipolar I or II disorder with a rapid-cycling disease course. Methods: Adult patients with a DSM-IV diagnosis of bipolar disorder, most recent episode depressed, with a rapid-cycling disease course from a previously completed multicenter trial randomized to 8 weeks of treatment with quetiapine 600 mg/day (n=31), quetiapine 300 mg/day (n=42), or placebo (n=35) were included in this sub-analysis. The primary efficacy variable was change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Results: Quetiapine (600 and 300 mg/day) provided significantly greater mean reductions from baseline to week 8 in the MADRS total score than placebo (-21.1, -20.7 versus -11.6, both p<0.001) in this patient population. Effect sizes in patients with a rapid-cycling disease course were 1.2 (600 mg/day) and 1.1 (300 mg/day) and were similar for bipolar I (0.98 and 1.22) and bipolar II (1.45 and 0.97) sub-groups. Significant improvements were also noted on the Clinical Global Impression, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Pittsburgh Sleep Quality Index, and Quality of Life Enjoyment and Satisfaction Questionnaire scales. Quetiapine was generally well tolerated with moderate increases in weight and extrapyramidal side effects compared to placebo. The incidence of treatment-emergent mania was similar to placebo. Conclusions: Quetiapine monotherapy (600 or 300 mg/day) is clinically effective and well tolerated in the short-term treatment of depressive episodes in patients with bipolar I or II disorder who have a rapid-cycling disease course.",
author = "Eduard Vieta and Calabrese, {J. R.} and Goikolea, {J. M.} and S. Raines and W. Macfadden and Mohammed Alam and Valerie Arnold and Charles Bailey and Guy Brannon and David Brown and Joseph Calabrese and John Carman and Andrew Cutler and Bernadette D'Souza and Naresh Emmanuel and Lawrence Ginsberg and Ram Gopalan and William Granger and Laszlo Gyulai and Howard Hassman and Saul Helfing and George Joseph and Paul Keck and Terrence Ketter and Arif Khan and Ari Kiev and Irving Kolin and James Knutson and Michael Levy and Logue, {H. E.} and David Marks and Greg Mattingly and Charles Merideth and Janice Miller and Dennis Munjack and William Privitera and Fred Reimherr and Robert Riesenberg and Leon Rosenberg and Leon Rubenfaer and David Sack and Abbey Strauss and David Walling and Richard Weisler",
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T1 - Quetiapine monotherapy in the treatment of patients with bipolar I or II depression and a rapid-cycling disease course

T2 - A randomized, double-blind, placebo-controlled study

AU - Vieta, Eduard

AU - Calabrese, J. R.

AU - Goikolea, J. M.

AU - Raines, S.

AU - Macfadden, W.

AU - Alam, Mohammed

AU - Arnold, Valerie

AU - Bailey, Charles

AU - Brannon, Guy

AU - Brown, David

AU - Calabrese, Joseph

AU - Carman, John

AU - Cutler, Andrew

AU - D'Souza, Bernadette

AU - Emmanuel, Naresh

AU - Ginsberg, Lawrence

AU - Gopalan, Ram

AU - Granger, William

AU - Gyulai, Laszlo

AU - Hassman, Howard

AU - Helfing, Saul

AU - Joseph, George

AU - Keck, Paul

AU - Ketter, Terrence

AU - Khan, Arif

AU - Kiev, Ari

AU - Kolin, Irving

AU - Knutson, James

AU - Levy, Michael

AU - Logue, H. E.

AU - Marks, David

AU - Mattingly, Greg

AU - Merideth, Charles

AU - Miller, Janice

AU - Munjack, Dennis

AU - Privitera, William

AU - Reimherr, Fred

AU - Riesenberg, Robert

AU - Rosenberg, Leon

AU - Rubenfaer, Leon

AU - Sack, David

AU - Strauss, Abbey

AU - Walling, David

AU - Weisler, Richard

PY - 2007/6/1

Y1 - 2007/6/1

N2 - Objectives: To investigate the efficacy and tolerability of quetiapine monotherapy in patients with bipolar I or II disorder with a rapid-cycling disease course. Methods: Adult patients with a DSM-IV diagnosis of bipolar disorder, most recent episode depressed, with a rapid-cycling disease course from a previously completed multicenter trial randomized to 8 weeks of treatment with quetiapine 600 mg/day (n=31), quetiapine 300 mg/day (n=42), or placebo (n=35) were included in this sub-analysis. The primary efficacy variable was change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Results: Quetiapine (600 and 300 mg/day) provided significantly greater mean reductions from baseline to week 8 in the MADRS total score than placebo (-21.1, -20.7 versus -11.6, both p<0.001) in this patient population. Effect sizes in patients with a rapid-cycling disease course were 1.2 (600 mg/day) and 1.1 (300 mg/day) and were similar for bipolar I (0.98 and 1.22) and bipolar II (1.45 and 0.97) sub-groups. Significant improvements were also noted on the Clinical Global Impression, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Pittsburgh Sleep Quality Index, and Quality of Life Enjoyment and Satisfaction Questionnaire scales. Quetiapine was generally well tolerated with moderate increases in weight and extrapyramidal side effects compared to placebo. The incidence of treatment-emergent mania was similar to placebo. Conclusions: Quetiapine monotherapy (600 or 300 mg/day) is clinically effective and well tolerated in the short-term treatment of depressive episodes in patients with bipolar I or II disorder who have a rapid-cycling disease course.

AB - Objectives: To investigate the efficacy and tolerability of quetiapine monotherapy in patients with bipolar I or II disorder with a rapid-cycling disease course. Methods: Adult patients with a DSM-IV diagnosis of bipolar disorder, most recent episode depressed, with a rapid-cycling disease course from a previously completed multicenter trial randomized to 8 weeks of treatment with quetiapine 600 mg/day (n=31), quetiapine 300 mg/day (n=42), or placebo (n=35) were included in this sub-analysis. The primary efficacy variable was change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Results: Quetiapine (600 and 300 mg/day) provided significantly greater mean reductions from baseline to week 8 in the MADRS total score than placebo (-21.1, -20.7 versus -11.6, both p<0.001) in this patient population. Effect sizes in patients with a rapid-cycling disease course were 1.2 (600 mg/day) and 1.1 (300 mg/day) and were similar for bipolar I (0.98 and 1.22) and bipolar II (1.45 and 0.97) sub-groups. Significant improvements were also noted on the Clinical Global Impression, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Pittsburgh Sleep Quality Index, and Quality of Life Enjoyment and Satisfaction Questionnaire scales. Quetiapine was generally well tolerated with moderate increases in weight and extrapyramidal side effects compared to placebo. The incidence of treatment-emergent mania was similar to placebo. Conclusions: Quetiapine monotherapy (600 or 300 mg/day) is clinically effective and well tolerated in the short-term treatment of depressive episodes in patients with bipolar I or II disorder who have a rapid-cycling disease course.

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