Bipolar Disorder Clinical Trial
Official title:
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.
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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