SchizophreniaPhase 4NCT00108368
The Effects of Risperidone and Olanzapine on Thinking
A Phase 4 study testing Risperidone and Olanzapine in people with Schizophrenia and Psychotic Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition. Hypothesis: Risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- Risperidone and Olanzapine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Mar 2006
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with schizophrenia disorder by a DSM IV.
- Competent to sign informed consent
- No history of poor response to Risperdal and Zyprexa
- No organic brain disease
Who cannot join
- Mental retardation or any chronic medical illness which results in the patient not being appropriate for a switch to Risperdal or Zyprexa.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
Official title: The Cognitive Effects of Risperidone and Olanzapine
The goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition.
Hypothesis: Risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- Risperidone, Olanzapine
- Keywords
- schizophrenia, cognition, antipsychotic medication, information processing, social cognition, Psychotic
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
OlanzapineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startOct 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Janssen, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108368
- Sponsor's protocol ID
- MHBS-057-00S
- Status last verified
- Sep 2007
- First submitted
- 14 Apr 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
Publications
Sergi M, Green M, Widmark C, Reist C, Erhart S, Braff D, Kee K, Marder S, Mintz J. Social Cognition and Neurocognition: Effects of Risperidone, Olanzapine, and Haloperidol. Am J Psychiatry. 2007 Oct 1;164(10):1585-1592. doi: 10.1176/appi.ajp.2007.06091515.
PubMed 22688151Sergi MJ, Green MF, Widmark C, Reist C, Erhart S, Braff DL, Kee KS, Marder SR, Mintz J. Social cognition [corrected] and neurocognition: effects of risperidone, olanzapine, and haloperidol. Am J Psychiatry. 2007 Oct;164(10):1585-92. doi: 10.1176/appi.ajp.2007.06091515.
PubMed 17898351
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive Effects of Risperidone and Olanzapine
- ClinicalTrials.gov ID
- NCT00108368
- Acronym / sponsor ID
- MHBS-057-00S
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- schizophrenia, cognition, antipsychotic medication, information processing, social cognition, Psychotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Janssen, LP
- Study start
- Oct 2003
- Study completion
- Mar 2006
- First posted
- 15 Apr 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 goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition.
Hypothesis: Risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with schizophrenia disorder by a DSM IV.
- Competent to sign informed consent
- No history of poor response to Risperdal and Zyprexa
- No organic brain disease
Key exclusion criteria (1 listed)
- Mental retardation or any chronic medical illness which results in the patient not being appropriate for a switch to Risperdal or Zyprexa.
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 |
|---|---|---|
| Risperidone | Drug | – |
| Olanzapine | Drug | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
- Derived from this study: PubMed 22688151Sergi M, Green M, Widmark C, Reist C, Erhart S, Braff D, Kee K, Marder S, Mintz J. Social Cognition and Neurocognition: Effects of Risperidone, Olanzapine, and Haloperidol. Am J Psychiatry. 2007 Oct 1;164(10):1585-1592. doi: 10.1176/appi.ajp.2007.06091515.
- Derived from this study: PubMed 17898351Sergi MJ, Green MF, Widmark C, Reist C, Erhart S, Braff DL, Kee KS, Marder SR, Mintz J. Social cognition [corrected] and neurocognition: effects of risperidone, olanzapine, and haloperidol. Am J Psychiatry. 2007 Oct;164(10):1585-92. doi: 10.1176/appi.ajp.2007.06091515.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone and Olanzapine in people with Schizophrenia and Psychotic Disorders, run by US Department of Veterans Affairs 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 1 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 21 Jan 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00108368, which also lists 2 linked publications.
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 21 Jan 2009.