Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania. — Lithium2  

Bipolar Disorder Clinical Trial

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.

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The following are the objectives of this study:

1. To determine if lithium is more efficacious in reducing symptoms of mania than placebo.

2. To describe the short-term safety of lithium in the pediatric population relative to placebo treatment.

3. To examine the effectiveness and efficacy of lithium as a maintenance treatment for children and adolescents with bipolar I disorder.

4. To examine the long-term and short-term safety and tolerability of lithium in pediatric bipolar I disorder.

5. To examine the effects of lithium treatment over time on specific aspects of cognitive functioning that have been reported to be adversely affected by lithium in the adult population.

6. More specifically, to determine the integrity of fine-motor, attention, verbal memory, and selected executive function domains prior to treatment at baseline, at the end of week 8/early termination of the Efficacy Phase, and at the end of week 24/early termination from the Long- Term Effectiveness Phase (after 24/32 weeks of lithium treatment).

7. To examine the relationship between systemic exposure to lithium and effectiveness and toxicity.

8. To examine the long-term safety and tolerability of combination therapy, lithium plus other psychotropic agents, in pediatric bipolar I disorder.

9. To critically assess the efficacy of lithium for prophylaxis against recurrence of mood symptoms in children and adolescents.

10. In those participants who discontinue treatment with lithium and experience a mood relapse, to determine the duration of lithium treatment necessary before re-stabilization is achieved.

11. To evaluate the influence of intrinsic factors [e.g. age, gender, race, renal function, height, (measured by stadiometer) and weight] on lithium exposure.

The Study population for this study: Children and adolescents 7- 17 years of age who meet DSM-IV diagnostic criteria for Bipolar I (mania, mixed mania) without psychotic symptoms as determined by a child and adolescent psychiatrist will be eligible for this study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

• NCT number: NCT01166425
• Study type: Interventional
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2010
• Completion date: April 2013