NCT01000402|UnknownPhase 4DMC
Juvenile Bipolar Disorder Outpatient Program
ProCAB
Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder
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Sponsor study identifier
interventional
150
1 country
1
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 22, 2009
Actual (reported)October 23, 2009
Actual (reported)October 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI
Naturalistic Study - 2-year follow-up
Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder
Naturalistic 2-year follow-up
Changes in ADHD symptoms according to SNAP-IV
Naturalistic 2-year follow-up
Changes in Anxiety symptoms according to the SCARED-C and SCARED-P
Naturalistic 2-year follow-up
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
Naturalistic 2-year follow-up
Presence and onset of adverse events secondary to treatment
Naturalistic 2-year follow-up
Changes in SMD symptoms according to the Mood Symptom Questionnaire
Naturalistic 2-year follow-up
No specific arms; Treatment decision based on available guidelines
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90350-903, Brazil
Luis A Rohde, D.Sc.
Federal University of Rio Grande do Sul
First Submitted
October 22, 2009
First Posted
October 23, 2009
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 23, 2009
Record last verified: 2009-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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