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:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01224067
Eligibility Criteria:
Inclusion Criteria:
* Male and female outpatients, age 18-65.
* Diagnosis of Social Anxiety Disorder (SAD), generalized subtype, by DSM-IV criteria.
* Liebowitz Social Anxiety Scale (LSAS) rating greater than or equal to 50 for both phases.
* Hamilton Depression Scale (HAM-D-17) score less than or equal to 16.
Exclusion Criteria:
* Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
* Patients with current or history of bipolar disorder, schizophrenia, or other psychotic conditions.
* Patients with a history of alcohol or substance abuse or dependence within the last six months or a positive toxicology screen consistent with abuse at baseline.
* Patients with significant unstable medical illness, including any medical pathology considered not well-controlled with conventional treatment, i.e., that may require during the study period medication adjustment, ongoing tests or procedures, intensive treatment or hospitalization. In addition, baseline laboratory tests will be conducted and required to be within normal limits or have no clinical significance for patient entry in the study.
* Severe personality disorders likely to interfere with study participation or who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.
* Ongoing psychotherapy directed toward the treatment of social anxiety disorder.
* History of hypersensitivity to sertraline and quetiapine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01224067
Study Brief:
Protocol Section:
NCT01224067