- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00295412
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients
February 21, 2006 updated by: Université de Montréal
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Montreal, Quebec, Canada, H1N 3V2
- Centre de recherche Fernand-Seguin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with as schizophrenia spectrum disorder
- Patients with a comorbid substance use disorder
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Emmanuel Stip, Md, MSc, CSPQ, Centre de recherche Fernand-Seguin, Hôpital Louis-H Lafontaine, Departement of Psychiatry, Faculty of medicine, University of Montreal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 21, 2006
First Submitted That Met QC Criteria
February 21, 2006
First Posted (Estimate)
February 23, 2006
Study Record Updates
Last Update Posted (Estimate)
February 23, 2006
Last Update Submitted That Met QC Criteria
February 21, 2006
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Substance-Related Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- 5077-99904
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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