Efficacy of valproate versus lithium in mania or mixed mania

A randomized, open 12-week trial

Charles L. Bowden, Sergey Mosolov, Luchezar Hranov, Eric Chen, Hussain Habil, Ronnachai Kongsakon, Robert Manfredi, Hsin Nan Lin

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

The objective of this study was to compare the efficacy and safety of valproate and lithium in bipolar I patients experiencing a manic or a mixed episode. This international, randomized, open-label, parallel-group, equivalence study included 268 patients with bipolar I disorder. The starting dose of valproate was 20mg/kg/day and that of lithium was 800mg/day. Treatment duration was 12 weeks. The primary outcome measure was mean change in Young Mania Rating Scale score between baseline and study end. Secondary outcome measures were response and remission rates, change in Montgomery and Åsberg Depression Rating Scale and Clinical Global Impression Bipolar Disorder instrument score, and occurrence of adverse events. The mean change from baseline in Young Mania Rating Scale score was 15.8±5.3 in the lithium group and 17.3±9.4 in the valproate group. The 90% confidence interval of the intergroup difference (-0.69; 3.31) was within prespecified equivalence limits. Response rates were 72.6% in the lithium group and 79.5% in the valproate group. Remission rates were 58.5 and 71.9%, respectively. No intergroup differences were observed in median time to treatment response (21 days) or change in Clinical Global Impression Bipolar Disorder instrument or Montgomery and Åsberg Depression Rating Scale scores. Adverse events were reported in 42.8% of patients in the lithium group and 41.5% in the valproate group. Valproate and lithium showed comparable efficacy and tolerability in the treatment of acute mania over 12 weeks.

Original languageEnglish (US)
Pages (from-to)60-67
Number of pages8
JournalInternational Clinical Psychopharmacology
Volume25
Issue number2
DOIs
StatePublished - Mar 2010

Fingerprint

Valproic Acid
Bipolar Disorder
Lithium
Outcome Assessment (Health Care)
Depression
Therapeutics
Confidence Intervals
Safety

Keywords

  • Acute mania
  • Bipolar disorder
  • Eastern Europe
  • Lithium
  • South East Asia
  • Valproate

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

Cite this

Efficacy of valproate versus lithium in mania or mixed mania : A randomized, open 12-week trial. / Bowden, Charles L.; Mosolov, Sergey; Hranov, Luchezar; Chen, Eric; Habil, Hussain; Kongsakon, Ronnachai; Manfredi, Robert; Lin, Hsin Nan.

In: International Clinical Psychopharmacology, Vol. 25, No. 2, 03.2010, p. 60-67.

Research output: Contribution to journalArticle

Bowden, CL, Mosolov, S, Hranov, L, Chen, E, Habil, H, Kongsakon, R, Manfredi, R & Lin, HN 2010, 'Efficacy of valproate versus lithium in mania or mixed mania: A randomized, open 12-week trial', International Clinical Psychopharmacology, vol. 25, no. 2, pp. 60-67. https://doi.org/10.1097/YIC.0b013e328333ac1b
Bowden, Charles L. ; Mosolov, Sergey ; Hranov, Luchezar ; Chen, Eric ; Habil, Hussain ; Kongsakon, Ronnachai ; Manfredi, Robert ; Lin, Hsin Nan. / Efficacy of valproate versus lithium in mania or mixed mania : A randomized, open 12-week trial. In: International Clinical Psychopharmacology. 2010 ; Vol. 25, No. 2. pp. 60-67.
@article{93c0579c901a4222a7f8825be6c6d445,
title = "Efficacy of valproate versus lithium in mania or mixed mania: A randomized, open 12-week trial",
abstract = "The objective of this study was to compare the efficacy and safety of valproate and lithium in bipolar I patients experiencing a manic or a mixed episode. This international, randomized, open-label, parallel-group, equivalence study included 268 patients with bipolar I disorder. The starting dose of valproate was 20mg/kg/day and that of lithium was 800mg/day. Treatment duration was 12 weeks. The primary outcome measure was mean change in Young Mania Rating Scale score between baseline and study end. Secondary outcome measures were response and remission rates, change in Montgomery and {\AA}sberg Depression Rating Scale and Clinical Global Impression Bipolar Disorder instrument score, and occurrence of adverse events. The mean change from baseline in Young Mania Rating Scale score was 15.8±5.3 in the lithium group and 17.3±9.4 in the valproate group. The 90{\%} confidence interval of the intergroup difference (-0.69; 3.31) was within prespecified equivalence limits. Response rates were 72.6{\%} in the lithium group and 79.5{\%} in the valproate group. Remission rates were 58.5 and 71.9{\%}, respectively. No intergroup differences were observed in median time to treatment response (21 days) or change in Clinical Global Impression Bipolar Disorder instrument or Montgomery and {\AA}sberg Depression Rating Scale scores. Adverse events were reported in 42.8{\%} of patients in the lithium group and 41.5{\%} in the valproate group. Valproate and lithium showed comparable efficacy and tolerability in the treatment of acute mania over 12 weeks.",
keywords = "Acute mania, Bipolar disorder, Eastern Europe, Lithium, South East Asia, Valproate",
author = "Bowden, {Charles L.} and Sergey Mosolov and Luchezar Hranov and Eric Chen and Hussain Habil and Ronnachai Kongsakon and Robert Manfredi and Lin, {Hsin Nan}",
year = "2010",
month = "3",
doi = "10.1097/YIC.0b013e328333ac1b",
language = "English (US)",
volume = "25",
pages = "60--67",
journal = "International Clinical Psychopharmacology",
issn = "0268-1315",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - Efficacy of valproate versus lithium in mania or mixed mania

T2 - A randomized, open 12-week trial

AU - Bowden, Charles L.

AU - Mosolov, Sergey

AU - Hranov, Luchezar

AU - Chen, Eric

AU - Habil, Hussain

AU - Kongsakon, Ronnachai

AU - Manfredi, Robert

AU - Lin, Hsin Nan

PY - 2010/3

Y1 - 2010/3

N2 - The objective of this study was to compare the efficacy and safety of valproate and lithium in bipolar I patients experiencing a manic or a mixed episode. This international, randomized, open-label, parallel-group, equivalence study included 268 patients with bipolar I disorder. The starting dose of valproate was 20mg/kg/day and that of lithium was 800mg/day. Treatment duration was 12 weeks. The primary outcome measure was mean change in Young Mania Rating Scale score between baseline and study end. Secondary outcome measures were response and remission rates, change in Montgomery and Åsberg Depression Rating Scale and Clinical Global Impression Bipolar Disorder instrument score, and occurrence of adverse events. The mean change from baseline in Young Mania Rating Scale score was 15.8±5.3 in the lithium group and 17.3±9.4 in the valproate group. The 90% confidence interval of the intergroup difference (-0.69; 3.31) was within prespecified equivalence limits. Response rates were 72.6% in the lithium group and 79.5% in the valproate group. Remission rates were 58.5 and 71.9%, respectively. No intergroup differences were observed in median time to treatment response (21 days) or change in Clinical Global Impression Bipolar Disorder instrument or Montgomery and Åsberg Depression Rating Scale scores. Adverse events were reported in 42.8% of patients in the lithium group and 41.5% in the valproate group. Valproate and lithium showed comparable efficacy and tolerability in the treatment of acute mania over 12 weeks.

AB - The objective of this study was to compare the efficacy and safety of valproate and lithium in bipolar I patients experiencing a manic or a mixed episode. This international, randomized, open-label, parallel-group, equivalence study included 268 patients with bipolar I disorder. The starting dose of valproate was 20mg/kg/day and that of lithium was 800mg/day. Treatment duration was 12 weeks. The primary outcome measure was mean change in Young Mania Rating Scale score between baseline and study end. Secondary outcome measures were response and remission rates, change in Montgomery and Åsberg Depression Rating Scale and Clinical Global Impression Bipolar Disorder instrument score, and occurrence of adverse events. The mean change from baseline in Young Mania Rating Scale score was 15.8±5.3 in the lithium group and 17.3±9.4 in the valproate group. The 90% confidence interval of the intergroup difference (-0.69; 3.31) was within prespecified equivalence limits. Response rates were 72.6% in the lithium group and 79.5% in the valproate group. Remission rates were 58.5 and 71.9%, respectively. No intergroup differences were observed in median time to treatment response (21 days) or change in Clinical Global Impression Bipolar Disorder instrument or Montgomery and Åsberg Depression Rating Scale scores. Adverse events were reported in 42.8% of patients in the lithium group and 41.5% in the valproate group. Valproate and lithium showed comparable efficacy and tolerability in the treatment of acute mania over 12 weeks.

KW - Acute mania

KW - Bipolar disorder

KW - Eastern Europe

KW - Lithium

KW - South East Asia

KW - Valproate

UR - http://www.scopus.com/inward/record.url?scp=76349118291&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=76349118291&partnerID=8YFLogxK

U2 - 10.1097/YIC.0b013e328333ac1b

DO - 10.1097/YIC.0b013e328333ac1b

M3 - Article

VL - 25

SP - 60

EP - 67

JO - International Clinical Psychopharmacology

JF - International Clinical Psychopharmacology

SN - 0268-1315

IS - 2

ER -