Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder

NCT00181935 | Completed Phase 4

• 1 other identifier: 2001-P-000422
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of extrapyramidal side effects.

Conditions

Bipolar Disorder; Mania

Keywords

bipolar disorder; preschoolers; risperdal; zyprexa

Outcome Measures

Primary Outcomes (3)

• reduction in symptoms measured by

• Young Mania Rating Scale

• Mania Symptom Checklist

Interventions

risperidone (Risperdal) DRUG

olanzapine (Zyprexa) DRUG

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female patients, 4-6 years of age.
• Parent or legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
• Patients and their legal representative must be considered reliable.
• Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document.
• Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
• Patients must have an initial score on the Y-MRS total score of at least 15.
• Patient must be able to participate in mandatory blood draws.

You may not qualify if:

• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
• Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
• Uncorrected hypothyroidism or hyperthyroidism.
• History of severe allergies or multiple adverse drug reactions.
• Non-febrile seizures without a clear and resolved etiology.
• Leukopenia or history of leukopenia without a clear and resolved etiology.
• Judged clinically to be at serious suicidal risk.
• Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol
• History of intolerance or non-responder to risperidone, or olanzapine as determined by the principal investigator.
• Treatment with nonreversible monoamine oxidase inhibitor within 2 weeks prior to Visit 2.
• Current diagnosis of schizophrenia.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Risperidone; Olanzapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2001
• Study Completion: July 1, 2004
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

US (1)