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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT00878150
Eligibility Criteria:
Inclusion Criteria:
* hospitalized for TBI within the last 10 years, and at least one month post-injury
* sustained a complicated mild to severe TBI as indicated by Glasgow Coma Scale score of 3-12 or had documented intracranial abnormalities on CT scan or had post-traumatic amnesia (PTA) of at least 7 days
* meet screening criteria for major depression
* speak English fluently
* resides in any of the the 50 United States
Exclusion Criteria:
* does not have a telephone
* does not have a stable address
* history of bipolar disorder or schizophrenia, or current psychosis or suicidal intent
* current alcohol or substance dependence (within last month)
* evidence of significant cognitive impairment on neuropsychological testing
* started on an antidepressant medication within 6 weeks or planning to start on an antidepressant within the 16-week study
* currently in psychotherapy for depression or plan to start psychotherapy for depression within the 16-week study period
* refusal to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00878150
Study Brief:
Protocol Section:
NCT00878150