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Juvenile Bipolar Disorder Outpatient Program (ProCAB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Federal University of Rio Grande do Sul.
Recruitment status was  Recruiting
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

October 22, 2009
October 22, 2009
February 2008
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Juvenile Bipolar Disorder Outpatient Program
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.

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

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Bipolar Disorder
  • Attention Deficit Disorder With Hyperactivity
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
Psychopharmacotherapy
No specific arms; Treatment decision based on available guidelines
Intervention: Drug: Psychopharmacotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
November 2014
October 2012   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
Yes
Contact: Silza Tramontina, D.Sc. +55 51 21018094 silza.tramontina@terra.com.br
Contact: Clarissa F Paim +55 51 21018094 cfpaim@hcpa.ufrgs.br
Brazil
 
NCT01000402
07-641
Yes
Luis Augusto Paim Rohde, Federal University of Rio Grande do Sul
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Principal Investigator: Luis A Rohde, D.Sc. Federal University of Rio Grande do Sul
Federal University of Rio Grande do Sul
October 2009

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