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:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT01896934
Eligibility Criteria:
Inclusion Criteria:
1. Age 60 years or older.
2. Current diagnosis of major depressive disorder (DSM-IV-TR), single episode, recurrent or chronic, without psychotic features, as detected by MINI and clinical exam.
3. Minimum MADRS score ≥ 15.
4. Mini-Mental State Exam ≥ 22.
5. Ability to read and write English.
Exclusion Criteria:
1. Current or past diagnoses of other Axis I psychiatric disorders, including panic disorder and substance dependence.
2. Any use of illicit substances (such as marijuana or cocaine) or abuse of prescription medications (such as benzodiazepines or opiates) within the last three months.
3. Presence of acute suicidality
4. Current or past psychosis
5. Known primary neurological disorder, including dementia, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
6. Chronic untreated medical disorders (including but not limited to hypertension, hyperlipidemia, fibromyalgia, hypothyroidism, or any other disorder) where treatment is warranted
7. Need for continuous oxygen use or any medical disorder where the hypercapnia challenge would be contraindicated or put the subject at increased risk. This would include active respiratory disease, chronic angina or other unstable cardiac conditions.
8. Any physical or intellectual disability affecting completion of assessments
9. MRI contraindications
10. Electroconvulsive therapy in last 6 months
11. Use of fluoxetine in the last 6 weeks. Occasional use of benzodiazepines or non-benzodiazepine sedatives (such as zolpidem, eszopiclone, or zaleplon) during the last month is allowable.
12. Known allergy or hypersensitivity to sertraline
13. A failed therapeutic trial of sertraline in the current depressive episode (defined as at least 6 weeks of treatment at a daily dose of 100mg or higher)
14. Current or planned psychotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01896934
Study Brief:
Protocol Section:
NCT01896934