Open-label lithium for the treatment of adolescents with bipolar depression.
OBJECTIVE
To investigate the effectiveness and tolerability of lithium for the treatment of acute depression in adolescents with bipolar disorder. We hypothesized that patients receiving open-label treatment with lithium during a 6-week period would experience a statistically and clinically significant decrease in depressive symptoms and tolerate lithium treatment fairly well.


METHODS
Twenty-seven adolescents (12-18 years old) with an episode of depression associated with bipolar disorder type I received open-label lithium 30 mg/kg (twice-daily dosing), which was adjusted to achieve a therapeutic serum level (1.0-1.2 mEq/L). Effectiveness measures included the Children's Depression Rating Scale-Revised (CDRS-R) and Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). Adverse events were assessed weekly.


RESULTS
Mean CDRS-R scores significantly decreased from baseline to endpoint (mean [SD] change = -25.5 (20.4); p < .001), resulting in a large effect size of 1.7. Response and remission rates (defined by a > or = 50% reduction in CDRS-R score from baseline to endpoint, and a CDRS-R score < or = 28 and a CGI-BP Improvement score of 1 or 2, respectively) were 48% and 30%. Side effects, which were generally mild to moderate in severity, included headache (74%), nausea/vomiting (67%), stomachache (30%), and abdominal cramps (19%).


CONCLUSIONS
The findings of this study indicate that lithium may be effective and is relatively well tolerated for the treatment of an acute episode of depression in adolescents with bipolar disorder. Controlled studies of lithium in adolescent bipolar depression are needed.
Dr. Patel is with the College of Pharmacy and Department of Psychiatry and Drs. DelBello, Adler, and Strakowski, and Ms. Bryan are with the Center for Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati; Dr. Kowatch is with the Division of Psychiatry at Cincinnati Children's Hospital Medical Center (CCHMC); Mr. Stanford is with the Department of Psychiatry, University of Cincinnati. Electronic address: nick.patel@uc.edu.
Nick C
NC
Patel
Dr. Patel is with the College of Pharmacy and Department of Psychiatry and Drs. DelBello, Adler, and Strakowski, and Ms. Bryan are with the Center for Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati; Dr. Kowatch is with the Division of Psychiatry at Cincinnati Children's Hospital Medical Center (CCHMC); Mr. Stanford is with the Department of Psychiatry, University of Cincinnati.
Melissa P
MP
Delbello
Dr. Patel is with the College of Pharmacy and Department of Psychiatry and Drs. DelBello, Adler, and Strakowski, and Ms. Bryan are with the Center for Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati; Dr. Kowatch is with the Division of Psychiatry at Cincinnati Children's Hospital Medical Center (CCHMC); Mr. Stanford is with the Department of Psychiatry, University of Cincinnati.
Holly S
HS
Bryan
Dr. Patel is with the College of Pharmacy and Department of Psychiatry and Drs. DelBello, Adler, and Strakowski, and Ms. Bryan are with the Center for Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati; Dr. Kowatch is with the Division of Psychiatry at Cincinnati Children's Hospital Medical Center (CCHMC); Mr. Stanford is with the Department of Psychiatry, University of Cincinnati.
Caleb M
CM
Adler
Dr. Patel is with the College of Pharmacy and Department of Psychiatry and Drs. DelBello, Adler, and Strakowski, and Ms. Bryan are with the Center for Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati; Dr. Kowatch is with the Division of Psychiatry at Cincinnati Children's Hospital Medical Center (CCHMC); Mr. Stanford is with the Department of Psychiatry, University of Cincinnati.
Robert A
RA
Kowatch
Dr. Patel is with the College of Pharmacy and Department of Psychiatry and Drs. DelBello, Adler, and Strakowski, and Ms. Bryan are with the Center for Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati; Dr. Kowatch is with the Division of Psychiatry at Cincinnati Children's Hospital Medical Center (CCHMC); Mr. Stanford is with the Department of Psychiatry, University of Cincinnati.
Kevin
K
Stanford
Dr. Patel is with the College of Pharmacy and Department of Psychiatry and Drs. DelBello, Adler, and Strakowski, and Ms. Bryan are with the Center for Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati; Dr. Kowatch is with the Division of Psychiatry at Cincinnati Children's Hospital Medical Center (CCHMC); Mr. Stanford is with the Department of Psychiatry, University of Cincinnati.
Stephen M
SM
Strakowski
D000293:Adolescent; D018692:Antimanic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D016651:Lithium Carbonate / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male
D018692:Antimanic Agents; D016651:Lithium Carbonate