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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01530204
Eligibility Criteria:
Inclusion Criteria:
1. \>/= age 60
2. meets accepted clinical criteria for knee OA based on the American College of Rheumatology 1986 clinical criteria guidelines.
3. Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score in the range of 7-15 (to minimize including subjects with knee OA so severe they may be better served by arthroplasty)
4. PHQ-9 scores 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.
5. Modified Mini Mental State (3MS) Examination \>/= 80.
6. Has or is willing to establish care with a personal physician prior to any experimental procedures.
Exclusion Criteria:
1. Major Depressive Episode or anxiety disorder within the past 1 year
2. Currently taking an antidepressant
3. History of bipolar or schizophrenia
4. Drug or alcohol use disorder within the past 12 months
5. Receiving knee-related workers compensation or involved in knee pain-related litigation.
6. Currently taking an anti-anxiety medicine \> 4 times/week for the past 4 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01530204
Study Brief:
Protocol Section:
NCT01530204