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Completed

NCT Number: NCT00057681

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's National Medical Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lithium Carbonate

Drug

Titrated until blood level is 1.1 to 1.3 mEq/L

Valproate

Drug

Titrated until blood level is 111 to 125 ug/mL

Other names: Depakote

Risperidone

Drug

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

Other names: Risperdal

Primary outcomes

  1. Clinical Global Impressions-Bipolar Mania Improvement

    Time frame: Measured at Week 8

    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.

Secondary outcomes

  1. Modified Side Effects Form for Children and Adolescents

    Time frame: Measured at Week 8

    The Modified Side Effects Form for Children and Adolescents includes 62 potential side effects, with measures of frequency and severity for each item. Frequencies are 0=not present, 1=1-2 days, 2=3-4 days, 3=5-7 days. Severity scores are 0=not present, 1=mild (does not interfere with functioning), 2=moderate (some interference with functioning), 3=severe (functioning is significantly impaired because of side effects). Items for cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nose, genito urinary, dermatology, musculo-skeletal, and other side effects are included. For analyses, side effects that were reported at any frequency and a severity of 2 or greater were considered present.

  2. K-SADS Mania Rating Scale

    Time frame: Measured at Week 8

    The K-SADS Mania Rating Scale (KMRS) is comprised of 15 items modified from WASH-U-KSADS items. The individual items are scored on a 1-6 severity scale and then these item scores are summed to create an overall KMRS score. Guidelines for interpretation are as follows: 0-11 = no or minimal mania, 12-17 = mild mania, 18-25 = moderate mania, 26+ = marked or worse mania. The maximum possible score is 64.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treatment of Early Age Mania (TEAM) Study

Acronym: TEAM

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Apr 7, 2003
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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