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Juvenile Bipolar Disorder Outpatient Program (ProCAB)

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ClinicalTrials.gov Identifier: NCT01000402
Recruitment Status : Unknown
Verified October 2009 by Federal University of Rio Grande do Sul.
Recruitment status was:  Recruiting
First Posted : October 23, 2009
Last Update Posted : October 23, 2009
Sponsor:
Collaborator:
Hospital de Clinicas de Porto Alegre
Information provided by:
Federal University of Rio Grande do Sul

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date October 23, 2009
Study Start Date  ICMJE February 2008
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
  • Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI [ Time Frame: Naturalistic Study - 2-year follow-up ]
  • Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder [ Time Frame: Naturalistic 2-year follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
  • Changes in ADHD symptoms according to SNAP-IV [ Time Frame: Naturalistic 2-year follow-up ]
  • Changes in Anxiety symptoms according to the SCARED-C and SCARED-P [ Time Frame: 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 [ Time Frame: Naturalistic 2-year follow-up ]
  • Presence and onset of adverse events secondary to treatment [ Time Frame: Naturalistic 2-year follow-up ]
  • Changes in SMD symptoms according to the Mood Symptom Questionnaire [ Time Frame: Naturalistic 2-year follow-up ]
  • Changes in general functioning according to the CGI and the CGAS [ Time Frame: Naturalistic 2-year follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Juvenile Bipolar Disorder Outpatient Program
Official Title  ICMJE Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder
Brief Summary 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Bipolar Disorder
  • Attention Deficit Disorder With Hyperactivity
Intervention  ICMJE 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
Study Arms  ICMJE Psychopharmacotherapy
No specific arms; Treatment decision based on available guidelines
Intervention: Drug: Psychopharmacotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000402
Other Study ID Numbers  ICMJE 07-641
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luis Augusto Paim Rohde, Federal University of Rio Grande do Sul
Study Sponsor  ICMJE Federal University of Rio Grande do Sul
Collaborators  ICMJE Hospital de Clinicas de Porto Alegre
Investigators  ICMJE
Principal Investigator: Luis A Rohde, D.Sc. Federal University of Rio Grande do Sul
PRS Account Federal University of Rio Grande do Sul
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP