Juvenile Bipolar Disorder Outpatient Program

Brief Summary

Official Title: “Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder”

This is an outpatient program for children and adolescents with bipolar disorders. The naturalistic approach of the program will allow a proper investigation of the disorder, assessment of environmental and biological factors, the conduction of treatment studies, and follow-up of the subjects.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
  • Study Primary Completion Date: October 2012

Detailed Clinical Trial Description

Inclusion criteria:

Age 6-17 years old, male and female. Bipolar Disorder I, II, and NOS (subjects presenting episodes of distinct abnormally and persistently elevated, expansive, or irritable mood, accompanied by at least three -or four if the mood is only irritable – Criteria B symptoms and present to a significant degree for at least 24 hours.

Severe Mood Dysregulation (SMD), as defined by Brotman et al. (American Journal of Psychiatry, 2007)

Exclusion criteria:

Presence of a diagnosis of Pervasive Developmental Disorder, Schizophrenia, Drug Use Disorder, and any other counter indications to outpatient treatment (significant suicide or homicide risk)


K-SADS-PL-W WASI Clinical Interview

Outcome Measures:

CBCL for general psychopathology YMRS, CMRS-P, CMRS-T for manic symptoms CDRS and CDI for depressive symptoms SNAP-IV for ADHD symptoms Scared-C and Scared-P for anxiety symptoms CGI for clinical impression, CGAS for global functioning Petersen Pubertal Scale Mood Symptom Questionnaire for SMD Screening tests for leaning disorders Family Environmental Scale, Life Events Scale, Expressed Emotion Adjective Checklist, Resilience Scale, Quality of Life for environmental and psychological factors Medication Adverse Events Checklist

Interventions Used in this Clinical Trial

  • Drug: Psychopharmacotherapy
    • Lithium (according to response, serum levels, and tolerance) 150-1500mg Valproate (according to response, serum levels, and tolerance) 125-2000mg Risperidone (according to response, and tolerance)0.5-6mg Olanzapine(according to response, and tolerance)2.5-20mg Ziprasidone(according to response, and tolerance)40-160mg Topiramate (according to response, and tolerance)25-300mg Quetiapine (according to response, and tolerance)25-500mg Aripiprazole (according to response, and tolerance)5-20mg Lamotrigine (according to response, and tolerance)25-200mg Fluoxetine (according to response, and tolerance) 1-40mg Sertraline (according to response, and tolerance)25-200mg Methylphenidate (according to weight, response, and tolerance)0.3 -0.7mg/kg/day

Arms, Groups and Cohorts in this Clinical Trial

  • Other: Psychopharmacotherapy
    • No specific arms; Treatment decision based on available guidelines

Outcome Measures for this Clinical Trial

Primary Measures

  • Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI
    • Time Frame: Naturalistic Study – 2-year follow-up
      Safety Issue?: Yes
  • Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder
    • Time Frame: Naturalistic 2-year follow-up
      Safety Issue?: No

Secondary Measures

  • Changes in ADHD symptoms according to SNAP-IV
    • Time Frame: Naturalistic 2-year follow-up
      Safety Issue?: Yes
  • Changes in Anxiety symptoms according to the SCARED-C and SCARED-P
    • Time Frame: Naturalistic 2-year follow-up
      Safety Issue?: Yes
  • Changes in family functioning according to the FES-R, individual functioning according to the EEAC and Resilience Scale, environmental factors according to the Stressful Life Events Scale
    • Time Frame: Naturalistic 2-year follow-up
      Safety Issue?: Yes
  • Presence and onset of adverse events secondary to treatment
    • Time Frame: Naturalistic 2-year follow-up
      Safety Issue?: Yes
  • Changes in SMD symptoms according to the Mood Symptom Questionnaire
    • Time Frame: Naturalistic 2-year follow-up
      Safety Issue?: No
  • Changes in general functioning according to the CGI and the CGAS
    • Time Frame: Naturalistic 2-year follow-up
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • 6-18 years-old;
  • Bipolar Disorder I, II or NOS
  • Severe Mood Dysregulation

Exclusion Criteria

  • Schizophrenia
  • Pervasive Developmental Disorder
  • Drug use disorder
  • Severe suicidal or homicidal risk, counterindicating outpatient treatment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Federal University of Rio Grande do Sul
  • Collaborator
    • Hospital de Clinicas de Porto Alegre
  • Provider of Information About this Clinical Study
    • Luis Augusto Paim Rohde, Federal University of Rio Grande do Sul
  • Overall Official(s)
    • Luis A Rohde, D.Sc., Principal Investigator, Federal University of Rio Grande do Sul
  • Overall Contact(s)
    • Silza Tramontina, D.Sc., +55 51 21018094, silza.tramontina@terra.com.br


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