ProCAB: Juvenile Bipolar Disorder Outpatient Program

• Sponsor: Federal University of Rio Grande do Sul (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01000402
• Collaborator: Hospital de Clinicas de Porto Alegre (Other)
• Enrollment: 150
• Location: 1
• Arm: 1
• Duration (Months): 81
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• 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: Feb 1, 2008
• Anticipated Primary Completion Date: Oct 1, 2012
• Anticipated Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: 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

Primary Outcome Measures

1. Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI [Naturalistic Study - 2-year follow-up]

2. Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder [Naturalistic 2-year follow-up]

Secondary Outcome Measures

1. Changes in ADHD symptoms according to SNAP-IV [Naturalistic 2-year follow-up]

2. Changes in Anxiety symptoms according to the SCARED-C and SCARED-P [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 [Naturalistic 2-year follow-up]

4. Presence and onset of adverse events secondary to treatment [Naturalistic 2-year follow-up]

5. Changes in SMD symptoms according to the Mood Symptom Questionnaire [Naturalistic 2-year follow-up]

6. Changes in general functioning according to the CGI and the CGAS [Naturalistic 2-year follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS	Brazil	90350-903

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Official Website of the ProCAB Outpatient Program

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01000402
• Other Study ID Numbers: 07-641
• First Posted: Oct 23, 2009
• Last Update Posted: Oct 23, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Bipolar Disorder; Attention-Deficit/Hyperactivity Disorder; Genetics; Environmental Factors; Family Factors
• Additional relevant MeSH terms: Hyperkinesis; Disease; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Oct 23, 2009