Schizoaffective Disorder, Schizophrenia, Substance Abuse, Substance Dependence
Conditions
Keywords
Cocaine Abuse, Cocaine Dependence, Amphetamine Abuse, Amphetamine Dependence, Schizophrenia, Comorbid, Schizoaffective Disorder
Brief summary
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.
Detailed description
Schizophrenia is a serious mental illness that afflicts approximately 1% of the population (1). Often these patients have comorbid cocaine and amphetamine dependence, which increases the severity of psychotic symptoms associated with schizophrenia, decreases treatment compliance and worsens prognosis. The treatment of schizophrenia with comorbid cocaine and/or amphetamine dependence is complex and involves adherence to psychiatric medications, most often antipsychotic agents, along with participation in specific substance abuse treatment such as structured living, attendance at self-help group meetings, individual and group therapy and a commitment to sobriety. In the absence of specific pharmacotherapy of cocaine and amphetamine dependence, various antipsychotic medications have been compared to see if they impact comorbid cocaine and amphetamine abuse in addition to their antipsychotic effects. The primary objective of this study is to test whether Seroquel as a mono-therapy decreases cocaine and/or methamphetamine use in patients with schizophrenia as compared to risperidone.
Interventions
DRUGQuetiapine
DRUGRisperidone
Sponsors
AstraZeneca
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 50% or greater decrease in the drug use determined by the Time Line Follow Back method versus baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed