Psychotic DisordersNCT00222495
A Comparative Study of New Medications for Psychosis in Adolescents
A study testing quetiapine, olanzapine and risperidone in people with Psychotic Disorders and Schizophrenia, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia, Schizophreniform Disorders
- What is being tested?
- quetiapine, olanzapine and risperidone
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
About this study
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.
Read the 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.
- Being tested
- quetiapine, olanzapine, risperidone
- Keywords
- Psychotic Disorders in adolescents, Schizophrenia in adolescents, Schizophreniform Disorders in adolescents, Schizoaffective Disorders in adolescents
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapineDrug
olanzapineDrug
risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2002
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Jensen, Jonathan B., M.D.
- Investigators
- Jonathan Jensen, M.D., Principal investigator, University of MinnesotaS. Charles Schulz, M.D., Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222495
- Sponsor's protocol ID
- 0205M26041
- Status last verified
- Sep 2006
- First submitted
- 16 Sep 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of New Medications for Psychosis in Adolescents
- ClinicalTrials.gov ID
- NCT00222495
- Acronym / sponsor ID
- 0205M26041
- Keywords
- Psychotic Disorders in adolescents, Schizophrenia in adolescents, Schizophreniform Disorders in adolescents, Schizoaffective Disorders in adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- AstraZeneca, Jensen, Jonathan B., M.D.
- Study start
- Aug 2002
- Study completion
- Aug 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quetiapine | Drug | – |
| olanzapine | Drug | – |
| risperidone | Drug | – |
Primary outcome
SCI-PANSS = Structured Clinical Interview - Positive and Negative Syndrome Scale
CGI = Clinical Global Impressions
GAF = Global Assessment of Functioning Scale
5 secondary outcomes
Neuropsychological assessment battery
Calgary Depression Symptoms for Schizophrenia
AIMS = Abnormal Involuntary Movement Scale
Barnes-Akathisia Rating Scale
SAS = Simpson Angus Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Jensen, M.D. principal investigator
University of Minnesota
S. Charles Schulz, M.D. study director
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quetiapine, olanzapine and risperidone in people with Psychotic Disorders and Schizophrenia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCI-PANSS = Structured Clinical Interview - Positive and Negative Syndrome Scale. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2006.