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ProCAB: Assessment and Follow-up of Pediatric Bipolar Disorder
NCT01000402Phase 4
Key facts
- Status
- Unknown
- Start
- Feb 2008
- Primary completion
- Oct 2012
- Countries
- 1
- Sponsor
- Universidade Federal do Rio Grande do Sul
- Modality
- DNA Intercalators/Alkylators
- Conditions
- bipolar disorder (BD)attention deficit hyperactivity disorder (ADHD)disruptive mood dysregulation disorder (DMDD)
01
Overview
Phase 4, open-label trial of lithium, valproic acid, risperidone, olanzapine, ziprasidone and 7 more in bipolar disorder (BD), attention deficit hyperactivity disorder (ADHD) and disruptive mood dysregulation disorder (DMDD), sponsored by Universidade Federal do Rio Grande do Sul. Primary endpoint: Young Mania Rating Scale at 2 years. Status: unknown.
02
Design
- Study design
- Non-randomizedOpen-label
03
Who it enrols
Children and adolescents aged 6-18 with Bipolar Disorder (I, II, or NOS) or Severe Mood Dysregulation, excluding those with Schizophrenia, PDD, or significant suicide/homicide risk.
04
Endpoints
Primary
Young Mania Rating Scale
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