A Phase 4 interventional study of Psychopharmacotherapy in Bipolar Disorder and Attention Deficit Disorder With Hyperactivity, sponsored by Federal University of Rio Grande do Sul. Status unknown at 1 site in Brazil. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-23.
Sponsored by Federal University of Rio Grande do Sul · Phase 4 and Interventional
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.
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
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Federal University of Rio Grande do Sul is the lead sponsor of 118 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Federal University of Rio Grande do Sul