Schizophrenia Clinical Trial
Official title:
Seroquel (Quetiapine) Therapy for Schizophrenia and Schizoaffective Disorders and Comorbid Cocaine and/or Amphetamine Abuse/Dependence: A Comparative Study With Risperidone
Verified date | October 2006 |
Source | Creighton University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
It is hypothesized that the atypical antipsychotic, Seroquel, will cause significant
reduction in drug and alcohol cravings in patients with schizophrenia and comorbid cocaine
and/methamphetamine dependence compared to the atypical antipsychotic, risperidone
(Risperdal).
Patients treated with Seroquel will have less use of cocaine and/or methamphetamine as
measured by the Time Line Follow-back, over a 24-week follow-up period.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Ages 19 - 65. 2. Diagnosis of schizophrenia or schizoaffective disorder with comorbid cocaine and/or amphetamine abuse/dependence as confirmed by Structured Clinical Interview for DSM-IV. 3. Comorbid diagnoses of depression, anxiety and/or personality disorders are permitted. 4. Ability to provide signed informed consent. 5. Stable general medical health. Exclusion Criteria: 1. Dangerous to self or others. 2. Pregnancy, inability or unwillingness to use approved methods of birth control. 3. Inability or unwillingness to provide signed informed consent. 4. Diagnosis of bipolar disorder, primary major depressive disorder (As major Axis I diagnosis). 5. Inability to attend outpatient research clinic. 6. Medical conditions, which would preclude use of Seroquel. 7. Absolute need for ongoing treatment with antipsychotic other than Seroquel. 8. Medical instability defined as likelihood of needing to change prescription medication during the course of the study. 9. Patients currently taking quetiapine or risperidone. 10. Patients with unsuccessful treatment with quetiapine or risperidone. 11. Subjects with a HAM-D score of =20 at screening. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Creighton University Psychiatry and Research Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Creighton University | AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 50% or greater decrease in the drug use determined by the Time Line Follow Back method versus baseline. | |||
Secondary | Psychiatric symptoms will be assessed with the CGI, PANSS, BPRS, HAM-D, and HAM-A.Safety and tolerability will be assessed by patient and physician reported adverse events and AIMS.Quality of life will be assessed with QoLI. |
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