Juvenile Bipolar Disorder Outpatient Program (ProCAB)

October 22, 2009 updated by: Federal University of Rio Grande do Sul

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90350-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI
Time Frame: Naturalistic Study - 2-year follow-up
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
Naturalistic 2-year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in ADHD symptoms according to SNAP-IV
Time Frame: Naturalistic 2-year follow-up
Naturalistic 2-year follow-up
Changes in Anxiety symptoms according to the SCARED-C and SCARED-P
Time Frame: Naturalistic 2-year follow-up
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
Naturalistic 2-year follow-up
Presence and onset of adverse events secondary to treatment
Time Frame: Naturalistic 2-year follow-up
Naturalistic 2-year follow-up
Changes in SMD symptoms according to the Mood Symptom Questionnaire
Time Frame: Naturalistic 2-year follow-up
Naturalistic 2-year follow-up
Changes in general functioning according to the CGI and the CGAS
Time Frame: Naturalistic 2-year follow-up
Naturalistic 2-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Luis A Rohde, D.Sc., Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Estimate)

October 23, 2009

Last Update Submitted That Met QC Criteria

October 22, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-641

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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