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Trial NCT00000385

Resource URI: http://static.linkedct.org/resource/trials/NCT00000385
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/18478>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/6208>
linkedct:brief_title Long-Term Lithium Treatment for Aggressive Conduct Disorder
linkedct:condition <http://static.linkedct.org/resource/condition/3185>
linkedct:condition <http://static.linkedct.org/resource/condition/676>
linkedct:criteria Inclusion Criteria: 1. Males and females 2. Ages between 9 and 17 years. 3. Conduct disorder according to DSM-IV (As rated on the DICA-IV). 4. The aggression criterion at screening Exclusion Criteria: 1. Mental Retardation. 2. Pervasive Developmental Disorder(s). 3. Major Depressive Disorder or Dysthymic Disorder. 4. Bipolar Disorder. 5. Psychotic Disorder (including Schizophreniform Disorder and Schizophrenia). 6. Major medical problem such as cardiac, renal, and thyroid diseases, or seizure disorder. 7. History of psychoactive medication in the previous 2 weeks. 8. Current Pregnancy in females. 9. History of Substance Dependence in the past month. 10. Prior to the proposed study, a history of lithium treatment with serum lithium levels of 0.4 mEq/L or higher for a cumulative period of greater than 10 days.
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 17 Years
linkedct:eligibility_minimum_age 9 Years
linkedct:end_date June 2005
linkedct:enrollment 59 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:has_dmc No
linkedct:id NCT00000385
linkedct:intervention <http://static.linkedct.org/resource/intervention/42128>
linkedct:intervention <http://static.linkedct.org/resource/intervention/42700>
rdfs:label Trial NCT00000385
linkedct:lastchanged_date April 15, 2008
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:location <http://static.linkedct.org/resource/location/160657>
linkedct:nct_id NCT00000385
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Long-Term Lithium for Aggressive Conduct Disorder
linkedct:org_study_id R29 MH57093
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/49954>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000385>
linkedct:phase Phase 3
linkedct:primary_completion_date December 2003
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/78635>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/78636>
linkedct:secondary_id DSIR CT-M
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/111372>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/26544>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/38051>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/59494>
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date September 1997
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
rdf:type linkedct:trials
linkedct:verification_date April 2008