Juvenile Bipolar Disorder Outpatient Program (ProCAB)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder; Attention Deficit Disorder With Hyperactivity	Drug: Psychopharmacotherapy	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder
Study Start Date :	February 2008
Estimated Primary Completion Date :	October 2012
Estimated Study Completion Date :	November 2014

Arms and Interventions

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Arm

Intervention/treatment

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

Outcome Measures

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Primary Outcome Measures :

1. Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI [ Time Frame: Naturalistic Study - 2-year follow-up ]
2. Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder [ Time Frame: Naturalistic 2-year follow-up ]

Secondary Outcome Measures :

1. Changes in ADHD symptoms according to SNAP-IV [ Time Frame: Naturalistic 2-year follow-up ]
2. Changes in Anxiety symptoms according to the SCARED-C and SCARED-P [ Time Frame: Naturalistic 2-year follow-up ]
3. 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 ]
4. Presence and onset of adverse events secondary to treatment [ Time Frame: Naturalistic 2-year follow-up ]
5. Changes in SMD symptoms according to the Mood Symptom Questionnaire [ Time Frame: Naturalistic 2-year follow-up ]
6. Changes in general functioning according to the CGI and the CGAS [ Time Frame: Naturalistic 2-year follow-up ]

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Official Website of the ProCAB Outpatient Program 

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
First Posted:	October 23, 2009
Last Update Posted:	October 23, 2009
Last Verified:	October 2009

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:

Disease; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Pathologic Processes; Bipolar and Related Disorders; Mental Disorders	Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms