Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder

NCT00181727

Bipolar Disorder Mania

COMPLETED PHASE4

Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents

NCT00195767

Bipolar I Disorder, Manic or Mixed

COMPLETED PHASE3

A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents

NCT00195780

Bipolar I Disorder

COMPLETED PHASE3

An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

NCT00067262

Bipolar Disorder

COMPLETED PHASE3

Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents

NCT00271258

Bipolar Disorder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Participants will receive treatment with lithium for 8 to 16 weeks

Group Type EXPERIMENTAL

Lithium carbonate

Intervention Type DRUG

Titrated until blood level is 1.1 to 1.3 mEq/L

2

Participants will receive treatment with valproate for 8 to 16 weeks

Group Type EXPERIMENTAL

Valproate

Intervention Type DRUG

Titrated until blood level is 111 to 125 ug/mL

3

Participants will receive treatment with risperidone for 8 to 16 weeks

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lithium carbonate

Titrated until blood level is 1.1 to 1.3 mEq/L

Intervention Type DRUG

Valproate

Titrated until blood level is 111 to 125 ug/mL

Intervention Type DRUG

Risperidone

Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Depakote Risperdal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks
* CGAS less than or equal to 60
* Good physical health

Exclusion Criteria

* Schizophrenia or any pervasive developmental disorder
* Major medical or neurological disease
* History of addiction to illicit substances or alcohol or drug abuse within the last 4 weeks
* IQ less than 70
* Pregnancy or breast-feeding
* Unacceptable methods of contraception
* In-patient care at baseline

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara Geller, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

University of Pittsburgh/WPIC

Pittsburgh, Pennsylvania, United States

Site Status

University of Texas

Galveston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Tillman R, Geller B, Klages T, Corrigan M, Bolhofner K, Zimerman B. Psychotic phenomena in 257 young children and adolescents with bipolar I disorder: delusions and hallucinations (benign and pathological). Bipolar Disord. 2008 Feb;10(1):45-55. doi: 10.1111/j.1399-5618.2008.00480.x.

Reference Type BACKGROUND

PMID: 18199241 (View on PubMed)

Geller B, Luby JL, Joshi P, Wagner KD, Emslie G, Walkup JT, Axelson DA, Bolhofner K, Robb A, Wolf DV, Riddle MA, Birmaher B, Nusrat N, Ryan ND, Vitiello B, Tillman R, Lavori P. A randomized controlled trial of risperidone, lithium, or divalproex sodium for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents. Arch Gen Psychiatry. 2012 May;69(5):515-28. doi: 10.1001/archgenpsychiatry.2011.1508. Epub 2012 Jan 2.

Reference Type RESULT

PMID: 22213771 (View on PubMed)

Walkup JT, Wagner KD, Miller L, Yenokyan G, Luby JL, Joshi PT, Axelson DA, Robb A, Salpekar JA, Wolf D, Sanyal A, Birmaher B, Vitiello B, Riddle MA. Treatment of Early-Age Mania: Outcomes for Partial and Nonresponders to Initial Treatment. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):1008-19. doi: 10.1016/j.jaac.2015.09.015. Epub 2015 Oct 8.

Reference Type DERIVED

PMID: 26598476 (View on PubMed)

Salpekar JA, Joshi PT, Axelson DA, Reinblatt SP, Yenokyan G, Sanyal A, Walkup JT, Vitiello B, Luby JL, Wagner KD, Nusrat N, Riddle MA. Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):999-1007.e4. doi: 10.1016/j.jaac.2015.09.016. Epub 2015 Oct 8.

Reference Type DERIVED

PMID: 26598475 (View on PubMed)

Vitiello B, Riddle MA, Yenokyan G, Axelson DA, Wagner KD, Joshi P, Walkup JT, Luby J, Birmaher B, Ryan ND, Emslie G, Robb A, Tillman R. Treatment moderators and predictors of outcome in the Treatment of Early Age Mania (TEAM) study. J Am Acad Child Adolesc Psychiatry. 2012 Sep;51(9):867-78. doi: 10.1016/j.jaac.2012.07.001. Epub 2012 Jul 31.

Reference Type DERIVED

PMID: 22917200 (View on PubMed)

Tillman R, Geller B. Diagnostic characteristics of child bipolar I disorder: does the "Treatment of Early Age Mania (team)" sample generalize? J Clin Psychiatry. 2007 Feb;68(2):307-14. doi: 10.4088/jcp.v68n0218.

Reference Type DERIVED

PMID: 17335331 (View on PubMed)