A Randomized, Double-Blind, Placebo Controlled Study of the Efficacy of Lithium for the Treatment of Pediatric Mania followed by an Open Label Long-Term Safety Period, Double-Blind, Placebo-Controlled Discontinuation Phase, and Open Label Restabilization

Focus of Study: 

Bipolar I Disorder, presently manic


mso-bidi-lThe purpose of this study is to learn about lithium in the treatment of pediatric patients with bipolar I disorder.  This is a multiphase treatment study.  Subjects will be eligible to continue to subsequent phases based on how well they respond to the study drug, lithium. 

The study will include four phases of treatment:

Phase 1 – Efficacy Phase which lasts 8 weeks

Phase 2 – Long-Term Effectiveness Phase which lasts up to 24 weeks

Phase 3 – Discontinuation Phase which lasts up to 28 weeks

Phase 4 – Restabilization Phase which lasts 8 weeks

Primary Completion Date: 
Ages of Eligibility: 
7-17 years
Inclusion Criteria: 
  • Subjects age 7 to 17
  • Patients must meet criteria for manic or mixed episodes in Bipolar I disorder;
  • The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements, and the legal guardian must give written informed consent and the youth, written assent;
  • The subject is willing and clinically able to discontinue exlusion medications during the screenign period and before beginning treatment with lithium. (No stable patients will be asked to discontinue medications);
  • ECG and blood work showing no clinically significant abnormalities.
Exclusion Criteria: 
  • Patient who is clinically stable on current medication regimen for bipolar disorder;
  • A current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder, Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder, or an IQ less than 70.
  • Positive drug screen at screening and on retest 1-3 weeks later or diagnosis of Substance Dependence;
  • Evidence of current serious homicidal/suicidal ideation and/or active hallucinations and delusions
  • Any use of medication that may interact with lithium (unless medication can be discontinued);                                         
  • Psychotherapy treatments started within 4 weeks of screening;
  • Previous adequate trial with lithium, or history of allergy to lithium, or history of lithium intolerance;
  • Psychiatric hospitalization within 1 month of screening for psychosis or serious homicidal/serious suicidal ideation;
  • Females who are currently pregnant or lactating, or sexually active females who are not using an adequate form of birth control;
  • Subjects who are unable to swallow the study medication;

Contact person : Cheryl Alderman 

Phone: 1-800-708-0048       

E-mail: ASPIRE@unc.edu


UNC Neurosciences Hospital DNC clinic

Sponsors & Collaborators: 



Linmarie Sikich, MD