Juvenile Bipolar Disorder Outpatient Program
- Conditions
- Bipolar DisorderAttention Deficit Disorder With Hyperactivity
- Interventions
- Drug: Psychopharmacotherapy
- Registration Number
- NCT01000402
- Lead Sponsor
- Federal University of Rio Grande do Sul
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 6-18 years-old;
- Bipolar Disorder I, II or NOS
- Severe Mood Dysregulation
- Schizophrenia
- Pervasive Developmental Disorder
- Drug use disorder
- Severe suicidal or homicidal risk, counterindicating outpatient treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Psychopharmacotherapy Psychopharmacotherapy No specific arms; Treatment decision based on available guidelines
- Primary Outcome Measures
Name Time Method Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI Naturalistic Study - 2-year follow-up Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder Naturalistic 2-year follow-up
- Secondary Outcome Measures
Name Time Method Changes in ADHD symptoms according to SNAP-IV Naturalistic 2-year follow-up Changes in Anxiety symptoms according to the SCARED-C and SCARED-P 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 Naturalistic 2-year follow-up Presence and onset of adverse events secondary to treatment Naturalistic 2-year follow-up Changes in SMD symptoms according to the Mood Symptom Questionnaire Naturalistic 2-year follow-up Changes in general functioning according to the CGI and the CGAS Naturalistic 2-year follow-up
Trial Locations
- Locations (1)
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil