Risperidone and quetiapine and olanzapine in Psychotic Disorders and Schizophrenia and Schizoaffective Disorders - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to compare the efficacy and tolerance of three atypical antipsychotics, which are medications that have been in use for about the last 10 years, in the treatment of psychosis in adolescents. Efficacy refers to how well the medications work in decreasing symptoms associated with schizophrenia, and tolerance refers to the level of side effects and the compliance with taking the medications. All three medications have demonstrated efficacy in treating psychosis without causing extra pyramidal side effects (uncontrolled muscle movements) that are associated with typical, or older antipsychotic medications. Young people may be at a greater risk for side effects from the typical antipsychotic medications. There are studies of the efficacy and tolerance among patients under 18-years-old taking the three drugs in this study: risperidone, olanzapine, and quetiapine. However, at this time there is little data available comparing these three medications. This study is an open-label, random assignment, 12-week study to assess the efficacy and tolerance of these three atypical antipsychotic medications in the treatment of adolescents (ages 12-18) with schizophrenia or psychosis. The participants will be informed of which medication she/he is taking, and will be assigned to the medication randomly (based on chance rather than choice).

There are additional theoretical beliefs in regard to this study as well. A secondary hypothesis of this study is that quetiapine will have less extra pyramidal side effects (EPS) and less prolactin-related side effects than risperidone. A third hypothesis is that quetiapine will lead to less weight gain than olanzapine and risperidone. Finally, it is hypothesized that because of the fewer side effects, quetiapine will be better tolerated than risperidone and olanzapine.

Study Type

Interventional

Enrollment

30

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Minneapolis, Minnesota, United States, 55454
    - University of Minnesota Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects are between the ages of 12-18 and have a diagnosis of a psychotic illness.
Subject currently meets criteria for one of the following disorders: schizophrenia, schizoaffective disorder (mainly schizophrenic), schizophreniform disorder, and psychosis NOS.
Subject is in good physical health and not suffering from any medical disorder that might mimic psychosis or lead to medical difficulty with the study medications.
If subject is taking antipsychotic medication before study entry, their medicine will be discontinued for 1-4 days depending on symptoms.

Exclusion Criteria:

Subject has a medical disorders that would interfere with the study, such as epilepsy, thyroid disease, liver disease, AIDS, etc.
Subject currently has substance dependence.
Subject is talking a medication that inhibits or induces the cytochrome P450 3A4 (specific medications listed in Appendix of protocol).

3. Subject meets criteria for brief psychosis or mood disorder with psychotic features.

4. Female subject is pregnant or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
SCI-PANSS = Structured Clinical Interview - Positive and Negative Syndrome Scale
CGI = Clinical Global Impressions
GAF = Global Assessment of Functioning Scale

Secondary Outcome Measures

Outcome Measure
Neuropsychological assessment battery
Calgary Depression Symptoms for Schizophrenia
AIMS = Abnormal Involuntary Movement Scale
Barnes-Akathisia Rating Scale
SAS = Simpson Angus Scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

AstraZeneca

Jensen, Jonathan B., M.D.

Investigators

Principal Investigator: Jonathan Jensen, M.D., University of Minnesota
Study Director: S. Charles Schulz, M.D., University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria