Attention Deficit Disorder With Hyperactivity, Bipolar Disorder
Conditions
Keywords
Bipolar Disorder, Attention-Deficit/Hyperactivity Disorder, Genetics, Environmental Factors, Family Factors
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
Interventions
DRUGPsychopharmacotherapy
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
Sponsors
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder | Naturalistic 2-year follow-up |
| Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI | Naturalistic Study - 2-year follow-up |
Secondary
| Measure | Time frame |
|---|---|
| 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 ADHD symptoms according to SNAP-IV | Naturalistic 2-year follow-up |
| Changes in general functioning according to the CGI and the CGAS | Naturalistic 2-year follow-up |
| Changes in SMD symptoms according to the Mood Symptom Questionnaire | Naturalistic 2-year follow-up |
| Changes in Anxiety symptoms according to the SCARED-C and SCARED-P | Naturalistic 2-year follow-up |
Countries
Brazil
Contacts
Primary ContactSilza Tramontina, D.Sc.
Backup ContactClarissa F Paim
Outcome results
None listed