This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
Psychotherapeutic agents are often administered without sufficient testing to children and adolescents, often on a long-term basis, to reduce aggression. Many pressures, including managed care, will increase the utilization of pharmacotherapy in the outpatient setting to treat serious problems. Lithium is the most promising agent for the treatment of aggression in children and adolescents. However, it has not been shown that lithium is an effective treatment for these patients in the outpatient (non-hospital) setting, or on a long-term basis. The purpose of this study is to examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression). The proposed study is a two-phased clinical trial of lithium for the treatment of aggression in conduct disorder. Both phases are double-blind and placebo-controlled with randomization and employ a parallel groups design. Phase 1 contains a short-term 8-week controlled trial, with twice as many subjects randomized to lithium as placebo, increasing the pool of potential lithium responders to continue to Phase 2. In Phase 2, lithium responders from Phase 1 enter a 6-month long-term controlled trial. Every attempt is made to define responders to lithium.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, United States
Overt Aggression Scale-Modified
Time frame: Weekly in short term phase, Monthly in long-term phase
Clinical Global Impressions-Improvement Item
Time frame: Weekly in short term phase, Monthly in long-term phase
Children's Psychiatric Rating Scale-Selected Items
Time frame: Weekly in short term phase, Monthly in long-term phase
IOWA
Time frame: Weekly in short term phase, Monthly in long-term phase
DOTES
Time frame: Weekly in short term phase, Monthly in long-term phase
TESS
Time frame: Weekly in short term phase, Monthly in long-term phase
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.