NCT00057681

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
379

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2003

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 27, 2013

Completed
Last Updated

April 4, 2013

Status Verified

March 1, 2013

Enrollment Period

5.8 years

First QC Date

April 4, 2003

Results QC Date

May 29, 2012

Last Update Submit

March 27, 2013

Conditions

Bipolar Disorder

Keywords

Mania

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impressions-Bipolar Mania Improvement

    The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.

    Measured at Week 8

Secondary Outcomes (2)

  • Modified Side Effects Form for Children and Adolescents

    Measured at Week 8

  • K-SADS Mania Rating Scale

    Measured at Week 8

Study Arms (3)

1

EXPERIMENTAL

Participants will receive treatment with lithium for 8 to 16 weeks

Drug: Lithium carbonate

2

EXPERIMENTAL

Participants will receive treatment with valproate for 8 to 16 weeks

Drug: Valproate

3

EXPERIMENTAL

Participants will receive treatment with risperidone for 8 to 16 weeks

Drug: Risperidone

Interventions

Lithium carbonateDRUG

Titrated until blood level is 1.1 to 1.3 mEq/L

1
ValproateDRUG

Titrated until blood level is 111 to 125 ug/mL

Also known as: Depakote
2
RisperidoneDRUG

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

Also known as: Risperdal
3

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1093, United States

Location

University of Pittsburgh/WPIC

Pittsburgh, Pennsylvania, 15208, United States

Location

University of Texas

Galveston, Texas, 77555, United States

Location

Related Publications (6)

  • 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.

    PMID: 18199241BACKGROUND

  • 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.

    PMID: 22213771RESULT

  • 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.

    PMID: 26598476DERIVED

  • 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.

    PMID: 26598475DERIVED

  • 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.

    PMID: 22917200DERIVED

  • 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.

    PMID: 17335331DERIVED

MeSH Terms

Conditions

Bipolar DisorderMania

Interventions

Lithium CarbonateValproic AcidRisperidone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium CompoundsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Barbara Geller, M.D.
Organization
Washington University in St. Louis
gellerb@wustl.edu
314-747-3657

Study Officials

  • Barbara Geller, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2003

First Posted

April 7, 2003

Study Start

February 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 4, 2013

Results First Posted

March 27, 2013

Record last verified: 2013-03

Locations

US(5)