Juvenile Bipolar Disorder Outpatient Program

Bipolar Disorder Clinical Trial

— ProCAB  

Official title:

Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01000402
• Other study ID #: 07-641
• Status: Recruiting
• Phase: Phase 4
• First received: October 22, 2009
• Last updated: October 22, 2009
• Start date: February 2008
• Est. completion date: November 2014

Study information

• Verified date: October 2009
• Source: Federal University of Rio Grande do Sul
• Contact: Silza Tramontina, D.Sc.
• Phone: +55 51 21018094
• Email: silza.tramontina[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Bipolar Disorder
• Disease
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI		Naturalistic Study - 2-year follow-up	Yes
Primary	Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder		Naturalistic 2-year follow-up	No
Secondary	Changes in ADHD symptoms according to SNAP-IV		Naturalistic 2-year follow-up	Yes
Secondary	Changes in Anxiety symptoms according to the SCARED-C and SCARED-P		Naturalistic 2-year follow-up	Yes
Secondary	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	Yes
Secondary	Presence and onset of adverse events secondary to treatment		Naturalistic 2-year follow-up	Yes
Secondary	Changes in SMD symptoms according to the Mood Symptom Questionnaire		Naturalistic 2-year follow-up	No
Secondary	Changes in general functioning according to the CGI and the CGAS		Naturalistic 2-year follow-up	Yes

External Links

•   Official Website of the ProCAB Outpatient Program