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 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT03428828
Eligibility Criteria:
Inclusion Criteria:
* right-handed adults (ages 18 - 55) with a primary diagnosis of MDD according to diagnostic criteria DSM-5 for recurrent MDD who are currently depressed will be recruited to participate
* must be able to give written informed consent prior to participation
* must have fewer than 45% memories categorized as specific on the Autobiographical Memory Test
* must have a SHAPS score \> 4, indicating the presence of anhedonia
* unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
* previously failed to respond to two previous SSRI medications according to either a medical record review or clinical interview during Visit 1
Exclusion Criteria:
* have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
* met DSM-IV criteria for alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
* have a history of traumatic brain injury
* are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
* are currently pregnant or breast feeding
* are unable to complete questionnaires written in English
* current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population
* have a DSM-5 diagnosis of psychotic or organic mental disorder, bipolar I or II disorder or any past or current manic or hypomanic symptoms, autism, or a primary diagnosis of an anxiety disorder (though co-morbid anxiety will not be excluded)
* have any eye problems or difficulties in corrected vision.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03428828
Study Brief:
Protocol Section:
NCT03428828