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
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