SchizophreniaNCT00018642
Quetiapine vs Haloperidol Decanoate for the Long Term Treatment of Schizophrenia and Schizoaffective Disorder
A study testing quetiapine and haloperidol decanoate in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- quetiapine and haloperidol decanoate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1997to Mar 2002
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia or Schizoaffective Disorder diagnosed by DSM-IV
- Between the ages 18-60.
- A candidate for maintenance antipsychotic therapy. This means that patients will have had at least two documented episodes of acute schizophrenic illness or at least two years of continuing psychotic symptoms.
Who cannot join
- Organic brain disease.
- Mental Retardation
- Chronic medical illness which would make antipsychotic medication inappropriate.
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: Predicting the Optimal Pharmacotherapy for Outpatients With Schizophrenia
The purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. The study will determine if quetiapine causes fewer problems than haloperidol with side effects such as stiffness and restlessness and whether it costs the VA more or less to treat patients with quetiapine. In addition, blood samples will be collected every three months to determine if certain chemicals in the blood can influence the outcome of the subjects' illness.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- quetiapine, haloperidol decanoate
- Keywords
- quetiapine, haloperidol decanoate
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapineDrug
haloperidol decanoateDrug
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 startApr 1997
- Study completionMar 2002
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018642
- Sponsor's protocol ID
- MHBS-042-96F
- 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
- Predicting the Optimal Pharmacotherapy for Outpatients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00018642
- Acronym / sponsor ID
- MHBS-042-96F
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- quetiapine, haloperidol decanoate
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 1997
- Study completion
- Mar 2002
- 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.
The purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. The study will determine if quetiapine causes fewer problems than haloperidol with side effects such as stiffness and restlessness and whether it costs the VA more or less to treat patients with quetiapine. In addition, blood samples will be collected every three months to determine if certain chemicals in the blood can influence the outcome of the subjects' illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Schizophrenia or Schizoaffective Disorder diagnosed by DSM-IV
- Between the ages 18-60.
- A candidate for maintenance antipsychotic therapy. This means that patients will have had at least two documented episodes of acute schizophrenic illness or at least two years of continuing psychotic symptoms.
Key exclusion criteria (3 listed)
- Organic brain disease.
- Mental Retardation
- Chronic medical illness which would make antipsychotic medication inappropriate.
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 | – |
| haloperidol decanoate | 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 study testing quetiapine and haloperidol decanoate in people with Schizophrenia and Schizoaffective Disorder, 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 3 inclusion and 3 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.
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.