Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT00352469
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of alcohol dependence and an anxiety disorder (generalized anxiety disorder, post traumatic disorder, panic disorder, obsessive compulsive disorder, etc.) based on Mini-International Neuropsychiatric Interview (MINI) for DSM IV.
2. Subject reports a minimum of 48 standard alcoholic drinks (or an average of 12 drinks/wk) in a consecutive 30-day period (i.e., a minimum of 40% days drinking), and has 2 or more days of heavy drinking (defined as ≥5 drinks/day in males and ≥4 drinks/day in females) in this same period as measured by the Time Line Follow Back.
3. Male and female patients between 19-65 years of age.
4. Ability to provide informed consent.
5. Medically and psychiatrically stable defined as not requiring inpatient treatment.
Exclusion Criteria:
1. Inability to provide informed consent.
2. Need for inpatient treatment
3. Need for inpatient detoxification for substance other than alcohol
4. Evidence of active dependence on a substance other than alcohol (with the exception of nicotine) as assessed by a urine drug screen.
5. Medically or psychiatrically unstable patients, defined as requiring inpatient treatment.
6. Pregnancy, nursing or refusal to use a reliable method of birth control in women.
7. Current treatment with other antipsychotic medications, which cannot be switched to Seroquel SR.
8. Patients with known allergy to Seroquel IR/SR or treatment failure to Seroquel IR/SR.
9. Exclude patients (pts) with unstable diabetes.
10. Exclude pts over 65
11. Exclude pts with dementia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT00352469
Study Brief:
Protocol Section:
NCT00352469