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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02376257
Eligibility Criteria:
Inclusion Criteria:
* Must have a DSM diagnosis of major depression as determined by structured diagnostic interview
* Must be free of psychotropic medications other than serotonin selective reuptake inhibitors (SSRIs) for at least 2 weeks
* No current suicidal ideation
* Able to speak and understand English
* Must be between the ages of 18 and 65, inclusive
* Must be a male, or a female who is not of childbearing potential (i.e., surgically sterile, postmenopausal for at least 1 year) or who is non-pregnant, non-lactating and using a medically accepted method of contraception. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, hormonal contraceptives. A woman of childbearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the trial
Exclusion Criteria:
* A DSM diagnosis of dementia, neurodegenerative disease, or other organic mental disorder; substance use disorder other than nicotine or caffeine in the last 3 months; bulimia or anorexia within the last 3 months; lifetime history of psychotic disorder or, bipolar disorder, or developmental disorder;
* A diagnosis of organic brain syndrome, mental retardation, or other cognitive dysfunction that could interfere with a participants capacity to participate in CBT or to complete safety and efficacy assessments
* A history of seizures (apart from childhood febrile seizures) or head trauma causing ongoing cognitive impairment
* An uncontrolled, unstable clinically significant medical condition (e.g., renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy, or poorly controlled hypertension (\> 150/90mmHg) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the study physician or investigator
* Medical illness including hypertension, cardiac disease, liver disease, pulmonary diseases, central nervous system disease, and epilepsy;
* Recent (1 year) suicidal attempts or current suicidal ideation
* For women, currently pregnant, plans to be pregnant in the next 2 months, or currently breastfeeding
* Treatment with phenytoin, isoniazid, or propranolol or known sensitivity to modafinil or cycloserine
* A history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment
* Use of psychotropic medication (including stimulants) other than SSRIs
* Current daily use of alcohol or regular binge alcohol use as determined on the medical screen
* Insufficient command of the English language (i.e., cannot carry on a conversation with an interviewer in the English language or read associated text)
* Receipt of CBT in the previous five years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02376257
Study Brief:
Protocol Section:
NCT02376257