Improving Sleep After TKA Using Mirtazapine and Quetiapine
NCT04728581 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165
Last updated 2023-06-02
Summary
Use of mirtazapine and quetiapine for improvement of sleep quality after TKA
Conditions
- Osteo Arthritis Knee
- Insomnia
Interventions
- DRUG
-
Mirtazapine
Use of 3.75mg mirtazapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 7.5mg mirtazapine.
- DRUG
-
Quetiapine
Use of 3.125mg quetiapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 6.25mg mirtazapine.
- DRUG
-
a gelatinous capsule without an active ingredient
Sponsors & Collaborators
-
St. Anna Ziekenhuis, Geldrop, Netherlands
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2026-05-01
- Completion
- 2027-01-01
Countries
- Netherlands
Study Locations
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