Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study

Jay A. Salpekar, Paramjit T. Joshi, David A. Axelson, Shauna P. Reinblatt, Gayane Yenokyan, Abanti Sanyal, John Walkup, Benedetto Vitiello, Joan Luby, Karen Wagner, Nasima Nusrat, Mark A. Riddle

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Objective: To assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder. Method: The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children and adolescents with. DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward. Results: CGI-BP-I-D ratings were better in the RISP group (60.7%) as compared to the LI (42.2%;. p = .03) or VAL (35.0%;. p = .003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95% CI = 2.67, 6.78), and compared to LI (mean = 3.63, 95% CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings. Conclusion: Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome + Clinical trial registration information-Treatment of Early Age Mania;. http://www.clinicaltrials.gov;. NCT00057681.

Original languageEnglish (US)
JournalJournal of the American Academy of Child and Adolescent Psychiatry
DOIs
StateAccepted/In press - 2015
Externally publishedYes

Fingerprint

Lithium Carbonate
Bipolar Disorder
Risperidone
Depression
Outcome Assessment (Health Care)
Clinical Trials
Pediatrics
Valproic Acid
Therapeutics
Diagnostic and Statistical Manual of Mental Disorders
Linear Models
Observation

Keywords

  • Bipolar
  • Clinical trial
  • Depression
  • Pediatrics
  • Treatment

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

Salpekar, J. A., Joshi, P. T., Axelson, D. A., Reinblatt, S. P., Yenokyan, G., Sanyal, A., ... Riddle, M. A. (Accepted/In press). Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study. Journal of the American Academy of Child and Adolescent Psychiatry. https://doi.org/10.1016/j.jaac.2015.09.016

Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study. / Salpekar, Jay A.; Joshi, Paramjit T.; Axelson, David A.; Reinblatt, Shauna P.; Yenokyan, Gayane; Sanyal, Abanti; Walkup, John; Vitiello, Benedetto; Luby, Joan; Wagner, Karen; Nusrat, Nasima; Riddle, Mark A.

In: Journal of the American Academy of Child and Adolescent Psychiatry, 2015.

Research output: Contribution to journalArticle

Salpekar, JA, Joshi, PT, Axelson, DA, Reinblatt, SP, Yenokyan, G, Sanyal, A, Walkup, J, Vitiello, B, Luby, J, Wagner, K, Nusrat, N & Riddle, MA 2015, 'Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study', Journal of the American Academy of Child and Adolescent Psychiatry. https://doi.org/10.1016/j.jaac.2015.09.016
Salpekar, Jay A. ; Joshi, Paramjit T. ; Axelson, David A. ; Reinblatt, Shauna P. ; Yenokyan, Gayane ; Sanyal, Abanti ; Walkup, John ; Vitiello, Benedetto ; Luby, Joan ; Wagner, Karen ; Nusrat, Nasima ; Riddle, Mark A. / Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2015.
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abstract = "Objective: To assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder. Method: The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children and adolescents with. DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward. Results: CGI-BP-I-D ratings were better in the RISP group (60.7{\%}) as compared to the LI (42.2{\%};. p = .03) or VAL (35.0{\%};. p = .003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95{\%} CI = 2.67, 6.78), and compared to LI (mean = 3.63, 95{\%} CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings. Conclusion: Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome + Clinical trial registration information-Treatment of Early Age Mania;. http://www.clinicaltrials.gov;. NCT00057681.",
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AU - Reinblatt, Shauna P.

AU - Yenokyan, Gayane

AU - Sanyal, Abanti

AU - Walkup, John

AU - Vitiello, Benedetto

AU - Luby, Joan

AU - Wagner, Karen

AU - Nusrat, Nasima

AU - Riddle, Mark A.

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N2 - Objective: To assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder. Method: The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children and adolescents with. DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward. Results: CGI-BP-I-D ratings were better in the RISP group (60.7%) as compared to the LI (42.2%;. p = .03) or VAL (35.0%;. p = .003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95% CI = 2.67, 6.78), and compared to LI (mean = 3.63, 95% CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings. Conclusion: Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome + Clinical trial registration information-Treatment of Early Age Mania;. http://www.clinicaltrials.gov;. NCT00057681.

AB - Objective: To assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder. Method: The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children and adolescents with. DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward. Results: CGI-BP-I-D ratings were better in the RISP group (60.7%) as compared to the LI (42.2%;. p = .03) or VAL (35.0%;. p = .003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95% CI = 2.67, 6.78), and compared to LI (mean = 3.63, 95% CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings. Conclusion: Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome + Clinical trial registration information-Treatment of Early Age Mania;. http://www.clinicaltrials.gov;. NCT00057681.

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