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A Comparative Study of New Medications for Psychosis in Adolescents

Primary Purpose

Psychotic Disorders, Schizophrenia, Schizophreniform Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
quetiapine
olanzapine
risperidone
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Psychotic Disorders in adolescents, Schizophrenia in adolescents, Schizophreniform Disorders in adolescents, Schizoaffective Disorders in adolescents

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2005
Last Updated
September 7, 2006
Sponsor
University of Minnesota
Collaborators
AstraZeneca, Jensen, Jonathan B., M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00222495
Brief Title
A Comparative Study of New Medications for Psychosis in Adolescents
Official Title
A Comparative Study of New Medications for Psychosis in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Minnesota
Collaborators
AstraZeneca, Jensen, Jonathan B., M.D.

4. Oversight

5. Study Description

Brief Summary
The overall goal of this study is to determine the efficacy and tolerability of three atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) in the treatment of adolescents with psychosis. It is hypothesized that the three medications will be equally effective in reducing the symptoms of psychosis.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorders
Keywords
Psychotic Disorders in adolescents, Schizophrenia in adolescents, Schizophreniform Disorders in adolescents, Schizoaffective Disorders in adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
quetiapine
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Type
Drug
Intervention Name(s)
risperidone
Primary Outcome Measure Information:
Title
SCI-PANSS = Structured Clinical Interview - Positive and Negative Syndrome Scale
Title
CGI = Clinical Global Impressions
Title
GAF = Global Assessment of Functioning Scale
Secondary Outcome Measure Information:
Title
Neuropsychological assessment battery
Title
Calgary Depression Symptoms for Schizophrenia
Title
AIMS = Abnormal Involuntary Movement Scale
Title
Barnes-Akathisia Rating Scale
Title
SAS = Simpson Angus Scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Jensen, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S. Charles Schulz, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Study Director
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

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