SchizophreniaPhase 4NCT00018668
Antipsychotic Response in Schizophrenia
A Phase 4 study testing Risperidone, Olanzapine and Quetiapine in people with Schizophrenia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a specific disease process, as in negative schizophrenia or depression or it can be the result of medications used to treat forms of mental illness. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone, Olanzapine and Quetiapine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Sep 2004
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Schizophrenia diagnosis currently treated with conventional antipsychotic willing to be switched to an atypical antipsychotic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veterans Affairs
San Diego, California, 92161
About this study
Official title: Psychopharmacologic Aspects of Motor Slowing in Schizophrenia
Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a specific disease process, as in negative schizophrenia or depression or it can be the result of medications used to treat forms of mental illness. Prior research has lead to a novel instrumental approach for distinguishing subtypes of motor slowing - one type related to cognitive processes and another related to parkinsonism. The purpose of this study is to test whether new medications used to treat schizophrenia improve the cognitive or parkinsonian components of motor slowing. Patients will be studied in the laboratory before and 8-weeks after starting a new antipsychotic. The n of this study = 60 patients. The results of this study will improve our understanding of the complex interactions between cognitive processing and motor behavior in patients with psychotic illnesses and how drugs work to treat these problems.
- Conditions
- Schizophrenia
- Being tested
- Risperidone, Olanzapine, Quetiapine
- Keywords
- Antipsychotics, schizophrenia, motor retardation, bradykinesia
- Medical subject headings
- Schizophrenia, Psychomotor Disorders, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
OlanzapineDrug
QuetiapineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startOct 2000
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018668
- Sponsor's protocol ID
- MHBS-041-00S
- Status last verified
- Dec 2004
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
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
- Psychopharmacologic Aspects of Motor Slowing in Schizophrenia
- ClinicalTrials.gov ID
- NCT00018668
- Acronym / sponsor ID
- MHBS-041-00S
- Conditions
- Schizophrenia
- Keywords
- Antipsychotics, schizophrenia, motor retardation, bradykinesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2000
- Study completion
- Sep 2004
- First posted
- 5 Jul 2001 (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.
Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a specific disease process, as in negative schizophrenia or depression or it can be the result of medications used to treat forms of mental illness. Prior research has lead to a novel instrumental approach for distinguishing subtypes of motor slowing - one type related to cognitive processes and another related to parkinsonism. The purpose of this study is to test whether new medications used to treat schizophrenia improve the cognitive or parkinsonian components of motor slowing. Patients will be studied in the laboratory before and 8-weeks after starting a new antipsychotic. The n of this study = 60 patients. The results of this study will improve our understanding of the complex interactions between cognitive processing and motor behavior in patients with psychotic illnesses and how drugs work to treat these problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | – |
| Quetiapine | 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.
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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, Olanzapine and Quetiapine in people with Schizophrenia, 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?
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?
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.