Juvenile Bipolar Disorder Outpatient Program (ProCAB)

Federal University of Rio Grande do Sul

Status and phase: Unknown; Phase 4

Conditions: Attention Deficit Disorder With Hyperactivity; Bipolar Disorder

Treatments: Drug: Psychopharmacotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01000402

07-641

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Psychopharmacotherapy

Other group

Description:

No specific arms; Treatment decision based on available guidelines

Treatment:

Drug: Psychopharmacotherapy