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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT02766192
Eligibility Criteria:
Inclusion Criteria:
1. Men or women, 21-60 years of age;
2. Patients attending the outpatient psychiatry clinic of Cooper University Hospital will be screened for this study using DSM-IV diagnostic criteria for PTSD.
3. Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document;
4. Participants must fulfill DSM-IV criteria for current civilian or combat-related PTSD, based on clinical assessment by a study psychiatrist, on the self-rated PTSD Check list (PCL-C scores must be at least 51and CAPS score must be at least 50 at screening on the first 17 items of the scale).
5. Women must be using a medically accepted reliable means of contraception (oral contraceptive medication etc.) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year);
6. Women of childbearing potential must have a negative pregnancy test at screening and pre-infusion;
7. Throughout this study, the participants will be on stable dosage(s) of medication(s).
Exclusion Criteria:
1. Meet criteria for psychotic disorders, e.g. schizophrenia/ schizoaffective disorder.
2. Women who are pregnant or are breast-feeding (because the medical risk of using ketamine during pregnancy and breast-feeding are unknown);
3. Serious, unstable medical illnesses such as hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease (including obstructive sleep apnea, history of difficulty with airway management during previous anesthetics, ischemic heart disease and uncontrolled hypertension, and history of severe head injury);
4. Clinically significant abnormal findings of laboratory parameters, or physical examination;
5. Patients with uncorrected hypothyroidism or hyperthyroidism;
6. Histories of mental retardation
7. History of one or more seizures without a clear and resolved etiology;
8. Drug or alcohol abuse or dependence within the preceding 3 months: phencyclidine (PCP) is especially important in this context because of its resemblance with ketamine not only in structure but also its pharmacodynamic effects on NMDA receptors.
9. Previous recreational use of ketamine;
10. Diagnosis of schizotypal or antisocial personality disorder (since these are known to reduce the possibility of study completion; other Axis II diagnoses will be allowed).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT02766192
Study Brief:
Protocol Section:
NCT02766192