CITALOPRAM for Osteoarthritis of hip and knee

Inclusion criteria

• {"criterion_text":"- 18 years of age or older at the time of inclusion"}
• {"criterion_text":"- Planed for primary unilateral THA/TKA/UKA"}
• {"criterion_text":"- Oral treatment with SSRI/SNRI*-tablet(s)/capsule(s) in any dose (*ATC codes: N06AB04, N06AB06, N06AB10, N06AB05, N06AX21)"}
• {"criterion_text":"- Understand written and spoken Danish language"}
• {"criterion_text":"- Signed written informed consent form"}

Exclusion criteria

• {"criterion_text":"- Earlier suicide attempt(s)"}
• {"criterion_text":"- Suicidal ideation"}
• {"criterion_text":"- Treatment with other psychopharmacological drugs than SSRIs/SNRIs except benzodiazepines** and 50 mg quetiapine (** ATC codes: N05BA*, N05CD* and N05CF)"}
• {"criterion_text":"- Depression or anxiety symptoms at the time of inclusion (MDI > 19 or SCL-92(anxiety) > Q3(sex))"}
• {"criterion_text":"- 2 or more depressive episodes the last 5 years"}
• {"criterion_text":"- Previous unsuccessful tapering of SSRIs/SNRIs"}
• {"criterion_text":"- Drug dependency"}
• {"criterion_text":"- Pregnancy"}

Primary endpoints

• {"endpoint_text":"- The proportion of patients planned for THA/TKA/UKA in SSRI/SNRI therapy, who are able to discontinue SSRI/SNRI therapy perioperatively.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- The proportions of patients planned for THA/TKA/UKA in SSRI/SNRI therapy, who opt out of the tapering of SSRI/SNRI therapy due to discontinuation syndrome, relapse of depression, relapse of anxiety or other reasons.","definition_or_measurement_approach":""}
• {"endpoint_text":"- The proportion of patients planned for THA/TKA/UKA in SSRI/SNRI therapy, who are not able to discontinue SSRI/SNRI therapy completely, but able to reduce their doses.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Discontinuation-Emergent Signs and Symptoms (DESS), Major Depression Inventory (MDI) and Symptom Checklist 92 (SCL-92) score at baseline, after 2 weeks, the day before surgery (after 5 weeks) and 2 months after surgery.","definition_or_measurement_approach":"Measured using DESS, MDI and SCL-92 at specified timepoints: baseline, 2 weeks, day before surgery (~5 weeks), and 2 months after surgery."}
• {"endpoint_text":"- The proportion of patients planned for THA/TKA/UKA in SSRI/SNRI therapy, who uses SSRIs/SNRIs 2 months after surgery.","definition_or_measurement_approach":""}
• {"endpoint_text":"- The proportion of patients planned for THA/TKA/UKA in SSRI/SNRI therapy able to discontinue SSRI/SNRI therapy perioperatively who uses SSRIs/SNRIs 2 months after surgery.","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

07-03-2024

Latest Decision Or Authorization Date

25-03-2024

Processing Time Days

18

Number Of Sites

5

Number Of Participants

100

Primary sponsor

Full Name

Sygehus Lillebaelt Vejle Sygehus

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties code: 1; contact email: GCP-enheden@rsyd.dk","organisation_type":"Hospital/Clinic/Other health care facility"}