Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.
Public ClinicalTrials.gov record NCT01166425. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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 Period.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study Design This is the second study of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric participants with bipolar I disorder. In order to examine the treatment of bipolar disorder with lithium, this study will include four phases of treatment. The first phase, the Efficacy Phase, will include participants being randomized to either lithium or placebo for 8 weeks to determine the efficacy of lithium in the treatment of children and adolescents with bipolar I disorder. Once participants complete the Efficacy Phase, participants may be eligible to continue in the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase, participants will be randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those participants who experience a mood relapse during the Discontinuation Phase will be enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks.
Study identification
- NCT ID
- NCT01166425
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- NIH
- Enrollment
- 81 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2010
- Primary completion
- Mar 31, 2013
- Completion
- Mar 31, 2013
- Last update posted
- Oct 8, 2013
2010 – 2013
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | — |
| University of Illinois at Chicago | South Chicago Heights | Illinois | 60612 | — |
| University of Kansas School of Medicine | Psychiatry and Behavioral Sciences, 1010 N Kansas St, Wichita | Kansas | 67214 | — |
| University of Massachusetts Medical School | Biotech One Suite 100, 365 Plantation, Worcester | Massachusetts | 01605 | — |
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | — |
| Columbia University | New York | New York | 10032 | — |
| University of North Carolina - Chapel Hill | Department of Psychiatry, CB 7160, Chapel Hill | North Carolina | 27599 | — |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 10032 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Seattle Childrens Hospital Research Institute | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01166425, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2013 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01166425 live on ClinicalTrials.gov.