A double-blind, randomized, placebo-controlled trial of oxcarbazepine in the treatment of bipolar disorder in children and adolescents

Karen Wagner, Robert A. Kowatch, Graham J. Emslie, Robert L. Findling, Timothy E. Wilens, Kevin McCague, Joseph D'Souza, Artur Wamil, Robert B. Lehman, Douglas Berv, David Linden

Research output: Contribution to journalArticle

Abstract

Objective: This multicenter trial examined the efficacy and safety of oxcarbazepine in the treatment of bipolar disorder in children and adolescents. Method: A total of 116 outpatients 7 to 18 years of age with bipolar I disorder, manic or mixed, were recruited at 20 centers in the United States and randomly assigned to receive 7 weeks of double-blinded, flexibly dosed treatment with oxcarbazepine (maximum dose 900-2400 mg/day) or placebo. The primary efficacy measure was the mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS), using the last-observation-carried-forward method. Results: Oxcarbazepine (mean dose= 1515 mg/day) did not significantly improve YMRS scores at endpoint compared with placebo [adjusted mean change: oxcarbazepine, -10.90 (N=55); placebo, -9.79 (N=55)]. Dizziness, nausea, somnolence, diplopia, fatigue, and rash were each reported in at least 5% of the patients in the oxcarbazepine group with an incidence at least twice that of the placebo group. The majority of adverse events were mild to moderate and occurred during the titration period. Eleven patients (19%) in the oxcarbazepine group discontinued the study because of adverse events, compared with two (4%) in the placebo group. Conclusions: Oxcarbazepine is not significantly superior to placebo in the treatment of bipolar disorder in youths. While the overall adverse event profile was similar to that reported for patients with epilepsy, the incidence of psychiatric adverse events for both the oxcarbazepine and placebo groups was higher than that reported for the epilepsy population.

Original languageEnglish (US)
Pages (from-to)1179-1186
Number of pages8
JournalAmerican Journal of Psychiatry
Volume163
Issue number7
DOIs
StatePublished - Jul 2006

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Bipolar Disorder
Randomized Controlled Trials
Placebos
Therapeutics
Epilepsy
Diplopia
oxcarbazepine
Incidence
Dizziness
Exanthema
Nausea
Multicenter Studies
Fatigue
Psychiatry
Outpatients
Observation
Safety
Population

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

A double-blind, randomized, placebo-controlled trial of oxcarbazepine in the treatment of bipolar disorder in children and adolescents. / Wagner, Karen; Kowatch, Robert A.; Emslie, Graham J.; Findling, Robert L.; Wilens, Timothy E.; McCague, Kevin; D'Souza, Joseph; Wamil, Artur; Lehman, Robert B.; Berv, Douglas; Linden, David.

In: American Journal of Psychiatry, Vol. 163, No. 7, 07.2006, p. 1179-1186.

Research output: Contribution to journalArticle

Wagner, K, Kowatch, RA, Emslie, GJ, Findling, RL, Wilens, TE, McCague, K, D'Souza, J, Wamil, A, Lehman, RB, Berv, D & Linden, D 2006, 'A double-blind, randomized, placebo-controlled trial of oxcarbazepine in the treatment of bipolar disorder in children and adolescents', American Journal of Psychiatry, vol. 163, no. 7, pp. 1179-1186. https://doi.org/10.1176/appi.ajp.163.7.1179
Wagner, Karen ; Kowatch, Robert A. ; Emslie, Graham J. ; Findling, Robert L. ; Wilens, Timothy E. ; McCague, Kevin ; D'Souza, Joseph ; Wamil, Artur ; Lehman, Robert B. ; Berv, Douglas ; Linden, David. / A double-blind, randomized, placebo-controlled trial of oxcarbazepine in the treatment of bipolar disorder in children and adolescents. In: American Journal of Psychiatry. 2006 ; Vol. 163, No. 7. pp. 1179-1186.
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abstract = "Objective: This multicenter trial examined the efficacy and safety of oxcarbazepine in the treatment of bipolar disorder in children and adolescents. Method: A total of 116 outpatients 7 to 18 years of age with bipolar I disorder, manic or mixed, were recruited at 20 centers in the United States and randomly assigned to receive 7 weeks of double-blinded, flexibly dosed treatment with oxcarbazepine (maximum dose 900-2400 mg/day) or placebo. The primary efficacy measure was the mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS), using the last-observation-carried-forward method. Results: Oxcarbazepine (mean dose= 1515 mg/day) did not significantly improve YMRS scores at endpoint compared with placebo [adjusted mean change: oxcarbazepine, -10.90 (N=55); placebo, -9.79 (N=55)]. Dizziness, nausea, somnolence, diplopia, fatigue, and rash were each reported in at least 5{\%} of the patients in the oxcarbazepine group with an incidence at least twice that of the placebo group. The majority of adverse events were mild to moderate and occurred during the titration period. Eleven patients (19{\%}) in the oxcarbazepine group discontinued the study because of adverse events, compared with two (4{\%}) in the placebo group. Conclusions: Oxcarbazepine is not significantly superior to placebo in the treatment of bipolar disorder in youths. While the overall adverse event profile was similar to that reported for patients with epilepsy, the incidence of psychiatric adverse events for both the oxcarbazepine and placebo groups was higher than that reported for the epilepsy population.",
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AU - Wagner, Karen

AU - Kowatch, Robert A.

AU - Emslie, Graham J.

AU - Findling, Robert L.

AU - Wilens, Timothy E.

AU - McCague, Kevin

AU - D'Souza, Joseph

AU - Wamil, Artur

AU - Lehman, Robert B.

AU - Berv, Douglas

AU - Linden, David

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N2 - Objective: This multicenter trial examined the efficacy and safety of oxcarbazepine in the treatment of bipolar disorder in children and adolescents. Method: A total of 116 outpatients 7 to 18 years of age with bipolar I disorder, manic or mixed, were recruited at 20 centers in the United States and randomly assigned to receive 7 weeks of double-blinded, flexibly dosed treatment with oxcarbazepine (maximum dose 900-2400 mg/day) or placebo. The primary efficacy measure was the mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS), using the last-observation-carried-forward method. Results: Oxcarbazepine (mean dose= 1515 mg/day) did not significantly improve YMRS scores at endpoint compared with placebo [adjusted mean change: oxcarbazepine, -10.90 (N=55); placebo, -9.79 (N=55)]. Dizziness, nausea, somnolence, diplopia, fatigue, and rash were each reported in at least 5% of the patients in the oxcarbazepine group with an incidence at least twice that of the placebo group. The majority of adverse events were mild to moderate and occurred during the titration period. Eleven patients (19%) in the oxcarbazepine group discontinued the study because of adverse events, compared with two (4%) in the placebo group. Conclusions: Oxcarbazepine is not significantly superior to placebo in the treatment of bipolar disorder in youths. While the overall adverse event profile was similar to that reported for patients with epilepsy, the incidence of psychiatric adverse events for both the oxcarbazepine and placebo groups was higher than that reported for the epilepsy population.

AB - Objective: This multicenter trial examined the efficacy and safety of oxcarbazepine in the treatment of bipolar disorder in children and adolescents. Method: A total of 116 outpatients 7 to 18 years of age with bipolar I disorder, manic or mixed, were recruited at 20 centers in the United States and randomly assigned to receive 7 weeks of double-blinded, flexibly dosed treatment with oxcarbazepine (maximum dose 900-2400 mg/day) or placebo. The primary efficacy measure was the mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS), using the last-observation-carried-forward method. Results: Oxcarbazepine (mean dose= 1515 mg/day) did not significantly improve YMRS scores at endpoint compared with placebo [adjusted mean change: oxcarbazepine, -10.90 (N=55); placebo, -9.79 (N=55)]. Dizziness, nausea, somnolence, diplopia, fatigue, and rash were each reported in at least 5% of the patients in the oxcarbazepine group with an incidence at least twice that of the placebo group. The majority of adverse events were mild to moderate and occurred during the titration period. Eleven patients (19%) in the oxcarbazepine group discontinued the study because of adverse events, compared with two (4%) in the placebo group. Conclusions: Oxcarbazepine is not significantly superior to placebo in the treatment of bipolar disorder in youths. While the overall adverse event profile was similar to that reported for patients with epilepsy, the incidence of psychiatric adverse events for both the oxcarbazepine and placebo groups was higher than that reported for the epilepsy population.

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