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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01246908
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 20 to 65 years of age
2. Able to read, understand and converse in English and provide written, dated informed consent
3. Diagnosed with Major Depressive Disorder (MDD)and Treatment Resistant Depression(TRD)
4. Females on acceptable method of contraception
Exclusion Criteria:
1. Major depressive episode greater than five years
2. A history of a Substance Use Disorder with the exception of nicotine dependence in the past 12 months
3. Obsessive-Compulsive Disorder (OCD), Panic Disorder, Post-traumatic Stress Disorder (PTSD
4. A history of schizophrenia or schizoaffective disorders
5. A history of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within the past five years
6. A history of Antisocial Personality Disorder or Borderline Personality Disorder
7. Recent suicidal behavior and is at risk of such behavior during the course of the study
8. Electroconvulsive therapy (ECT) within the past five years
9. Transcranial Magnetic Stimulation (TMS) for the treatment of the current episode of depression
10. Vagus Nerve Stimulation (VNS) at any time
11. Any psychoactive drugs within one to four weeks prior to the randomization visit depending on the type of drug
12. Significant abnormality on the screening physical examination
13. Significant cardiac abnormalities such as uncontrolled hypertension, recent myocardial infarction, Congestive heart failure (CHF), Angina pectoris
14. A history within the past two years of significant head trauma, surgical procedure involving the brain,degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation
15. A history of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months
16. A history of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening
17. Participation in an investigational study in the past one month
18. A positive screening urine test for drugs of abuse
19. Female subject who is pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01246908
Study Brief:
Protocol Section:
NCT01246908