Juvenile Bipolar Disorder Outpatient Program (ProCAB)
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ClinicalTrials.gov Identifier: NCT01000402 |
Recruitment Status
: Unknown
Verified October 2009 by Federal University of Rio Grande do Sul.
Recruitment status was: Recruiting
First Posted
: October 23, 2009
Last Update Posted
: October 23, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder Attention Deficit Disorder With Hyperactivity | Drug: Psychopharmacotherapy | Phase 4 |
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 (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 |

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
|
- Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI [ Time Frame: 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 ]
- Changes in ADHD symptoms according to SNAP-IV [ Time Frame: Naturalistic 2-year follow-up ]
- Changes in Anxiety symptoms according to the SCARED-C and SCARED-P [ Time Frame: 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 ]
- Presence and onset of adverse events secondary to treatment [ Time Frame: Naturalistic 2-year follow-up ]
- Changes in SMD symptoms according to the Mood Symptom Questionnaire [ Time Frame: Naturalistic 2-year follow-up ]
- Changes in general functioning according to the CGI and the CGAS [ Time Frame: Naturalistic 2-year follow-up ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000402
Contact: Silza Tramontina, D.Sc. | +55 51 21018094 | silza.tramontina@terra.com.br | |
Contact: Clarissa F Paim | +55 51 21018094 | cfpaim@hcpa.ufrgs.br |
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 |
Principal Investigator: | Luis A Rohde, D.Sc. | Federal University of Rio Grande do Sul |
Additional Information:
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 Key Record Dates |
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 |