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
Recruitment status was Recruiting
Sponsor:
Federal University of Rio Grande do Sul
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Attention Deficit Disorder With Hyperactivity |
Drug: Psychopharmacotherapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder |
Resource links provided by NLM:
Further study details as provided by Federal University of Rio Grande do Sul:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000402
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000402
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
Additional Information:
No publications provided
| 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 |
| Study First Received: | October 22, 2009 |
| Last Updated: | October 22, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
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:
|
Attention Deficit Disorder with Hyperactivity Bipolar Disorder Disease Affective Disorders, Psychotic Attention Deficit and Disruptive Behavior Disorders |
Mental Disorders Mental Disorders Diagnosed in Childhood Mood Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on March 01, 2015