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

Washington University School of Medicine379 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

379

Conditions

Bipolar Disorder

Interventions

Lithium carbonateDRUG

Titrated until blood level is 1.1 to 1.3 mEq/L

ValproateDRUG

Titrated until blood level is 111 to 125 ug/mL

RisperidoneDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (5)

Children's National Medical Center

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

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Pittsburgh/WPIC

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Measured at Week 8

Secondary Outcomes

Modified Side Effects Form for Children and Adolescents

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.

Time frame: Measured at Week 8

K-SADS Mania Rating Scale

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.

Time frame: Measured at Week 8

Data from ClinicalTrials.gov

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