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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT02484456
Eligibility Criteria:
* INCLUSION CRITERIA:
* 18 to 65 years of age.
* Subjects must have a level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding. To verify this, subjects must score greater than or equal to 80% on the consent quiz.
* Subjects must fulfill Diagnostic and Statistical Manual (DSM)-IV or DSM-V criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Subjects must be experiencing a current major depressive episode of at least 4 weeks duration.
* Subjects must have an initial score of at least 18 on the HDRS at screening and at baseline of study phase I.
* Subjects must have a current or past history of lack of response to one adequate antidepressant trial (may be from the same chemical class) operationally defined using the modified-Antidepressant Treatment History Form (ATHF).
EXCLUSION CRITERIA:
* Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V.
* Subjects with a history of DSM-IV drug or alcohol dependency or abuse (or alcohol use disorder per DSM-V),except for caffeine or nicotine dependence within the preceding 3 months.
* Head injury that results in loss of consciousness exceeding 5 minutes (for the imaging component of the study).
* Subjects with a DSM IV or DSM-V Axis II diagnosis of borderline or antisocial personality disorder.
* Pregnant or nursing women or women of child bearing potential not using at least 1 medically accepted means of contraception from the time of enrollment in the study until 1 month after completion of the second phase. Examples of medically accepted means of contraception include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence or partner with vasectomy. .
* Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
* Subjects with clinical hyperthyroidism or hypothyroidism.
* Subjects with one or more seizures without a clear and resolved etiology.
* Clinically significant abnormal laboratory tests.
* Treatment with a reversible monoamine oxidase inhibitor (MAOI) within 4 weeks of study phase II.
* Treatment with fluoxetine or aripiprazole within 5 weeks of study phase II.
* Treatment with any other disallowed concomitant medication or TMS 14 days before randomization.
* Treatment with clozapine or electroconvulsive therapy (ECT) within 1 month of randomization.
* Lifetime history of deep brain stimulation.
* Subjects who, in the Principal Investigator's judgment, pose a current serious suicidal or homicidal risk.
* Positive HIV test
* Contraindications to MRS (metal in body, claustrophobia, etc for imaging)
* No structured psychotherapy will be permitted during the total duration of the study. Subjects unable or unwilling to stop psychotherapy will be unable to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02484456
Study Brief:
Protocol Section:
NCT02484456