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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT00237393
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD.
* Score of at least 50 on the CAPS-SX at baseline.
* Competent to give informed consent.
* If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential.
* Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase.
* Other medications, if any, must have been kept stable for at least one month prior to randomization.
Exclusion Criteria:
* History of sensitivity to quetiapine
* Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period.
* Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease.
* Medical disorders that may cause or exacerbate anxiety symptoms.
* Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria.
* Schizophrenia, schizoaffective disorder, or bipolar disorder.
* Suicidal or homicidal ideation or other clinically significant dangerousness
* Currently seeking compensation or increase in compensation for the effects of the trauma.
* Initiation or change in psychotherapy within 3 months of randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00237393
Study Brief:
Protocol Section:
NCT00237393