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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT05466851
Eligibility Criteria:
Inclusion Criteria:
* 18 to 65 years of age.
* Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
* At the initial study enrollment, subjects must have fulfilled DSM-5 criteria for Major Depression, single episode or recurrent.
* At the initial study enrollment, subjects may have fulfilled DSM-5 criteria for an Anxiety Disorder Comorbid Psychiatric Disorders, specifically Anxiety Disorders (Panic Disorder, Specific Phobia, Social Anxiety Disorder, Generalized Anxiety Disorder), Obsessive Compulsive Disorder, or a prior diagnosis of Post-Traumatic Stress Disorder, and/or Attention Deficit Hyperactivity Disorder may be enrolled as per assessment and agreement of evaluating clinicians.
* Agree to participate in clinical treatment (medication management and psychotherapy)
Exclusion Criteria:
* Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
* History of head trauma or stroke (also known as a cerebrovascular accident).
* Clinically significant abnormal laboratory tests.
* Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold.
* Any use of opioid medication in the past 12 months
* Positive HIV test
* Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
* Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 12 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screen
* Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05466851
Study Brief:
Protocol Section:
NCT05466851