Phase 4
Completed N=23
Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder
Source: ClinicalTrials.gov NCT00156715 ↗Enrolled (actual)
23
Serious AEs
18.8%
Results posted
Dec 2010
Primary outcomePrimary: Mean Number of Drinking Days Per Week — 2.7 Drinking Days per Week
Summary
The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing substance use in persons diagnosed with schizophrenia. The primary hypothesis is that quetiapine treatment will be associated with a decrease in substance use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Drinking Days Per Week |
2.7 | — |
| SECONDARY Clinical Symptoms |
65.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-65
- Schizophrenia or schizoaffective disorder
- Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) criteria for a substance use disorder (alcohol use disorder [AUD]; abuse or dependence)
- Active substance use on at least 8 days during the 4 weeks prior to randomization.
- Current treatment with antipsychotic medication.
- Able to provide informed consent, or in the case of patients with legal court appointed guardians willing to give assent, with the consent of the guardian.
- Not actively suicidal.
Exclusion Criteria
- Current treatment with, decanoate antipsychotic, clozapine, or doses of quetiapine not approved by the team of investigators. Individuals treated with depot antipsychotic must wait until the end of their injection cycle before starting on study medication.
- Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
- Currently residing in a residential program designed to treat substance use disorders.
- Treatment at baseline with a psychotropic agent proposed to curtail substance use.
- Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.
- Unable to take part in the assessments in a meaningful way
- Hypersensitivity/intolerance to quetiapine
- Serious, unstable medical condition
- Participation in clinical trial of an investigational drug within 30 days of baseline visit, or concurrent participation in a treatment study of a psychosocial intervention
Data sourced from ClinicalTrials.gov (NCT00156715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.