SchizophreniaPhase 4NCT00295412
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients
A Phase 4 study testing quetiapine (drug) in people with Schizophrenia and Substance Use Disorders, run by Université de Montréal at 1 site in Canada.
Trial summary
The lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in schizophrenia is associated with negative consequences. Unfortunately, there no clear guidelines for the pharmacological treatment of this dual diagnosis population. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Substance Use Disorders
- What is being tested?
- quetiapine (drug)
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- 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 55 years
- All sexes
- Adult
Who may be able to join
- Patients with as schizophrenia spectrum disorder
- Patients with a comorbid substance use disorder
Who cannot join
- Patients already on quetiapine or clozapine
- Patients hospitalized or acutely ill
- Total score lower than 65 on the PANSS
- Pregnancy
- Female subjects of childbearing potential without adequate contraception
- Abnormal liver function (hepatic enzymes more than 3 times the upper normal limits)
- Any clinically meaningful unstable renal, hepatic, cardiovascular, respiratory, cerebrovascular disease or other serious, progressive physical disease.
Trial locations and contacts
1 site in 1 country.
About this study
The lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in schizophrenia is associated with negative consequences. Unfortunately, there no clear guidelines for the pharmacological treatment of this dual diagnosis population. Preliminary results suggest that second-generation antipsychotic drugs (mainly clozapine) may relieve drug cravings in schizophrenia. We performed a 12-week pilot study to evaluate the impact of quetiapine, a second-generation antipsychotic, on substance abuse parameters, psychiatric symptoms and side effects in patients schizophrenia and comorbid substance use disorders. Our expectation was a 20 % decrease in drug cravings from baseline to end-point.
- Conditions
- Schizophrenia, Substance Use Disorders
- Being tested
- quetiapine (drug)
- Medical subject headings
- Schizophrenia, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapine (drug)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Emmanuel Stip, Md, MSc, CSPQ, Principal investigator, Centre de recherche Fernand-Seguin, Hôpital Louis-H Lafontaine, Departement of Psychiatry, Faculty of medicine, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295412
- Sponsor's protocol ID
- 5077-99904
- Status last verified
- Sep 2005
- First submitted
- 21 Feb 2006
- Last updated
- 23 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00295412
- Acronym / sponsor ID
- 5077-99904
- Conditions
- Schizophrenia, Substance Use Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- AstraZeneca
- First posted
- 23 Feb 2006 (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 lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in schizophrenia is associated with negative consequences. Unfortunately, there no clear guidelines for the pharmacological treatment of this dual diagnosis population. Preliminary results suggest that second-generation antipsychotic drugs (mainly clozapine) may relieve drug cravings in schizophrenia. We performed a 12-week pilot study to evaluate the impact of quetiapine, a second-generation antipsychotic, on substance abuse parameters, psychiatric symptoms and side effects in patients schizophrenia and comorbid substance use disorders. Our expectation was a 20 % decrease in drug cravings from baseline to end-point.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with as schizophrenia spectrum disorder
- Patients with a comorbid substance use disorder
Key exclusion criteria (7 listed)
- Patients already on quetiapine or clozapine
- Patients hospitalized or acutely ill
- Total score lower than 65 on the PANSS
- Pregnancy
- Female subjects of childbearing potential without adequate contraception
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) | 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 23 Feb 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.
Emmanuel Stip, Md, MSc, CSPQ principal investigator
Centre de recherche Fernand-Seguin, Hôpital Louis-H Lafontaine, Departement of Psychiatry, Faculty of medicine, University of Montreal
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 quetiapine (drug) in people with Schizophrenia and Substance Use Disorders, run by Université de Montréal at 1 site in Canada.
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 2 inclusion and 7 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 23 Feb 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 Canada. 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 23 Feb 2006.