Lithium Treatment of Acute Mania in Adolescents: A Placebo-Controlled Discontinuation Study
Saved in:
| Title: | Lithium Treatment of Acute Mania in Adolescents: A Placebo-Controlled Discontinuation Study |
|---|---|
| Language: | English |
| Authors: | Kafantaris, Vivian, Coletti, Daniel J., Dicker, Robert |
| Source: | Journal of the American Academy of Child and Adolescent Psychiatry. Aug 2004 43(8):984-993. |
| Availability: | Lippincott Williams & Wilkins, P.O. Box 1620, Hagerstown, MD 21741. Tel: 800-638-3030 (Toll Free); Fax: 301-223-2400. |
| Peer Reviewed: | Y |
| Page Count: | 10 |
| Publication Date: | 2004 |
| Document Type: | Journal Articles Reports - Research Tests/Questionnaires |
| Descriptors: | Psychiatry, Adolescents, Statistical Significance, Drug Therapy, Outcomes of Treatment |
| ISSN: | 0890-8567 |
| Abstract: | Objective: There are no published placebo-controlled studies of any agent in the treatment of acute mania in children or adolescents. This is the first placebo-controlled study of lithium's efficacy in the treatment of acute mania in adolescents. Method: In this discontinuation study, participants received open treatment with lithium at therapeutic serum levels (mean 0.99 mEq/L) for at least 4 weeks. Responders were randomly assigned to continue or discontinue lithium during a 2-week double-blind, placebo-controlled phase. This study had 80% power to detect a 40% difference in exacerbation rates between groups (10% on lithium versus 50% on placebo). Results: Twenty-three of 40 protocol participants (57.5%) experienced a clinically significant symptom exacerbation during the 2-week double-blind phase. However, the slightly lower exacerbation rate in the group maintained on lithium (10/19 or 52.6%) versus the group switched to placebo (13/21 or 61.9%) did not reach statistical significance. Conclusions: This study does not support a large effect for lithium continuation treatment of adolescents with acute mania, mostly due to the unexpectedly high rate of exacerbations in the group that continued on lithium. Further studies are warranted to clarify whether acute mania in adolescents is lithium responsive. |
| Abstractor: | Author |
| Entry Date: | 2005 |
| Accession Number: | EJ696471 |
| Database: | ERIC |
| Abstract: | Objective: There are no published placebo-controlled studies of any agent in the treatment of acute mania in children or adolescents. This is the first placebo-controlled study of lithium's efficacy in the treatment of acute mania in adolescents. Method: In this discontinuation study, participants received open treatment with lithium at therapeutic serum levels (mean 0.99 mEq/L) for at least 4 weeks. Responders were randomly assigned to continue or discontinue lithium during a 2-week double-blind, placebo-controlled phase. This study had 80% power to detect a 40% difference in exacerbation rates between groups (10% on lithium versus 50% on placebo). Results: Twenty-three of 40 protocol participants (57.5%) experienced a clinically significant symptom exacerbation during the 2-week double-blind phase. However, the slightly lower exacerbation rate in the group maintained on lithium (10/19 or 52.6%) versus the group switched to placebo (13/21 or 61.9%) did not reach statistical significance. Conclusions: This study does not support a large effect for lithium continuation treatment of adolescents with acute mania, mostly due to the unexpectedly high rate of exacerbations in the group that continued on lithium. Further studies are warranted to clarify whether acute mania in adolescents is lithium responsive. |
|---|---|
| ISSN: | 0890-8567 |
