Clinical trial NCT01000402: Juvenile Bipolar Disorder Outpatient Program
Official title: Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bipolar Disorder
Attention Deficit Disorder With Hyperactivity
Keywords: Bipolar Disorder
Attention-Deficit/Hyperactivity Disorder
Genetics
Environmental Factors
Family Factors
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
First posted: 2009-10-23
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI
timeFrame: Naturalistic Study - 2-year follow-up
measure: Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder
timeFrame: Naturalistic 2-year follow-up
Secondary outcomes:
measure: Changes in ADHD symptoms according to SNAP-IV
timeFrame: Naturalistic 2-year follow-up
measure: Changes in Anxiety symptoms according to the SCARED-C and SCARED-P
timeFrame: Naturalistic 2-year follow-up
measure: 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
timeFrame: Naturalistic 2-year follow-up
measure: Presence and onset of adverse events secondary to treatment
timeFrame: Naturalistic 2-year follow-up
measure: Changes in SMD symptoms according to the Mood Symptom Questionnaire
timeFrame: Naturalistic 2-year follow-up
measure: Changes in general functioning according to the CGI and the CGAS
timeFrame: Naturalistic 2-year follow-up
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Luis A Rohde, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References: