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A Comparative Study of New Medications for Psychosis in Adolescents

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ClinicalTrials.gov Identifier: NCT00222495
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 11, 2006
Sponsor:
Collaborators:
AstraZeneca
Jensen, Jonathan B., M.D.
Information provided by:
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Schizophrenia Schizophreniform Disorders Schizoaffective Disorders Drug: quetiapine Drug: olanzapine Drug: risperidone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of New Medications for Psychosis in Adolescents
Study Start Date : August 2002
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. SCI-PANSS = Structured Clinical Interview - Positive and Negative Syndrome Scale
  2. CGI = Clinical Global Impressions
  3. GAF = Global Assessment of Functioning Scale

Secondary Outcome Measures :
  1. Neuropsychological assessment battery
  2. Calgary Depression Symptoms for Schizophrenia
  3. AIMS = Abnormal Involuntary Movement Scale
  4. Barnes-Akathisia Rating Scale
  5. SAS = Simpson Angus Scale


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects are between the ages of 12-18 and have a diagnosis of a psychotic illness.
  2. Subject currently meets criteria for one of the following disorders: schizophrenia, schizoaffective disorder (mainly schizophrenic), schizophreniform disorder, and psychosis NOS.
  3. 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.
  4. If subject is taking antipsychotic medication before study entry, their medicine will be discontinued for 1-4 days depending on symptoms.

Exclusion Criteria:

  1. Subject has a medical disorders that would interfere with the study, such as epilepsy, thyroid disease, liver disease, AIDS, etc.
  2. Subject currently has substance dependence.
  3. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222495


Locations
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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
AstraZeneca
Jensen, Jonathan B., M.D.
Investigators
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Principal Investigator: Jonathan Jensen, M.D. University of Minnesota - Clinical and Translational Science Institute
Study Director: S. Charles Schulz, M.D. University of Minnesota - Clinical and Translational Science Institute

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ClinicalTrials.gov Identifier: NCT00222495     History of Changes
Other Study ID Numbers: 0205M26041
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Psychotic Disorders in adolescents
Schizophrenia in adolescents
Schizophreniform Disorders in adolescents
Schizoaffective Disorders in adolescents
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Olanzapine
Risperidone
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents