A Comparative Study of New Medications for Psychosis in Adolescents

NCT00222495 | Completed

• 1 other identifier: 0205M26041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorders

Keywords

Psychotic Disorders in adolescents; Schizophrenia in adolescents; Schizophreniform Disorders in adolescents; Schizoaffective Disorders in adolescents

Outcome Measures

Primary Outcomes (3)

• SCI-PANSS = Structured Clinical Interview - Positive and Negative Syndrome Scale

• CGI = Clinical Global Impressions

• GAF = Global Assessment of Functioning Scale

Secondary Outcomes (5)

• Neuropsychological assessment battery

• Calgary Depression Symptoms for Schizophrenia

• AIMS = Abnormal Involuntary Movement Scale

• Barnes-Akathisia Rating Scale

• SAS = Simpson Angus Scale

Interventions

quetiapine DRUG

olanzapine DRUG

risperidone DRUG

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• \. Subject meets criteria for brief psychosis or mood disorder with psychotic features.
• \. Female subject is pregnant or nursing.

Sponsors & Collaborators

• University of Minnesota: lead
• AstraZeneca: collaborator
• Jensen, Jonathan B., M.D.: collaborator

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Quetiapine Fumarate; Olanzapine; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jonathan Jensen, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• S. Charles Schulz, M.D.

  University of Minnesota

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2002
• Study Completion: August 1, 2006
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

US (1)