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NCT00295412 Clinical Trial

The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients

Schizophrenia Clinical Trial

Official title:
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00295412
Other study ID # 5077-99904
Secondary ID
Status Completed
Phase Phase 4
First received February 21, 2006
Last updated February 21, 2006

Study information
Verified date September 2005
Source Université de Montréal
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• quetiapine (drug)

Locations
Country Name City State
Canada Centre de recherche Fernand-Seguin Montreal Quebec

Sponsors (2)
Lead Sponsor Collaborator
Université de Montréal AstraZeneca

Country where clinical trial is conducted

Canada, 

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