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Juvenile Bipolar Disorder Outpatient Program (ProCAB)

This study is currently recruiting participants.
Verified October 2009 by Federal University of Rio Grande do Sul
Sponsor:
Collaborator:
Hospital de Clinicas de Porto Alegre
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01000402
First received: October 22, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Attention Deficit Disorder With Hyperactivity
 Drug: Psychopharmacotherapy
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI [ Time Frame: Naturalistic Study - 2-year follow-up ] [ Designated as safety issue: Yes ]
  • Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder [ Time Frame: Naturalistic 2-year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in ADHD symptoms according to SNAP-IV [ Time Frame: Naturalistic 2-year follow-up ] [ Designated as safety issue: Yes ]
  • Changes in Anxiety symptoms according to the SCARED-C and SCARED-P [ Time Frame: Naturalistic 2-year follow-up ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Presence and onset of adverse events secondary to treatment [ Time Frame: Naturalistic 2-year follow-up ] [ Designated as safety issue: Yes ]
  • Changes in SMD symptoms according to the Mood Symptom Questionnaire [ Time Frame: Naturalistic 2-year follow-up ] [ Designated as safety issue: No ]
  • Changes in general functioning according to the CGI and the CGAS [ Time Frame: Naturalistic 2-year follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: February 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Psychopharmacotherapy
No specific arms; Treatment decision based on available guidelines
 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

Detailed 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)

Diagnosis:

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

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000402

Contacts
Contact: Silza Tramontina, D.Sc. +55 51 21018094 silza.tramontina@terra.com.br
Contact: Clarissa F Paim +55 51 21018094 cfpaim@hcpa.ufrgs.br

Locations
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90350-903
Contact: Clarissa F Paim     +55 51 21018094     cfpaim@hcpa.ufrgs.br    
Contact: Silza Tramontina, D.Sc.     +55 51 21018094     silza.tramontina@terra.com.br    
Principal Investigator: Luis A Rohde, D.Sc.            
Sub-Investigator: Silza Tramontina, D.Sc.            
Sub-Investigator: Cristian P Zeni, M.Sc.            
Sub-Investigator: Carla R Ketzer, M.Sc.            
Sub-Investigator: Gabriel F Pheula, MD            
Sub-Investigator: Fernanda V Krieger, MD            
Sub-Investigator: Sandra Petresco, M.Sc.            
Sub-Investigator: Roberta S Coelho, B.Sc.            
Sub-Investigator: Adriana F Perez, M.Sc.            
Sub-Investigator: Lanuzia Brum, BA            
Sub-Investigator: Ana P Guimaraes, M.Sc.            
Sub-Investigator: Henrique T Ludwig            
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Luis A Rohde, D.Sc. Federal University of Rio Grande do Sul
  More Information

Additional Information:
Official Website of the ProCAB Outpatient Program  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Luis Augusto Paim Rohde, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01000402     History of Changes
Other Study ID Numbers: 07-641
Study First Received: October 22, 2009
Last Updated: October 22, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
Bipolar Disorder
Attention-Deficit/Hyperactivity Disorder
Genetics
Environmental Factors
Family Factors

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Affective Disorders, Psychotic
Mood Disorders
 Mental Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013