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Study on Temporarily Stopping Duloxetine, Sertraline, and Paroxetine in Patients with Hip or Knee Osteoarthritis Undergoing Surgery

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What is this study about?

This clinical trial is focused on patients with hip and knee osteoarthritis who are scheduled for hip or knee replacement surgery. The study is investigating the possibility of temporarily stopping certain medications known as serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) before surgery. These medications include duloxetine, sertraline hydrochloride, paroxetine hydrochloride, citalopram, and citalopram hydrobromide. The purpose of the study is to see if patients can safely stop taking these medications for a short time without experiencing withdrawal symptoms or a return of depression and anxiety.

Participants in the study will be asked to stop taking their SSRI or SNRI medication for a short period before their surgery. The study will monitor how well patients manage without their medication and whether they experience any symptoms of withdrawal or a return of their mental health conditions. The study will also look at how many patients are able to reduce their medication dose if they cannot stop completely. Patients will be assessed at different times: at the start of the study, two weeks later, the day before surgery, and two months after surgery.

The study aims to understand the effects of stopping these medications temporarily and to gather information on how many patients can successfully do so. This information could help improve care for patients undergoing hip or knee replacement surgery who are taking SSRIs or SNRIs. The study will run until 2026, with recruitment starting in 2024.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as being 18 years or older, planning for hip or knee surgery, and current use of specific medications like duloxetine, sertraline, paroxetine, escitalopram, or citalopram.

Understanding of the Danish language and signing a consent form are also required.

2 medication adjustment

The study involves a temporary discontinuation or reduction of serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) before surgery.

Medications are taken orally in tablet or capsule form. The specific dosage and frequency depend on individual treatment plans.

3 monitoring period

During the study, symptoms related to discontinuation, depression, and anxiety are monitored using specific assessments like the Discontinuation-Emergent Signs and Symptoms (DESS), Major Depression Inventory (MDI), and Symptom Checklist 92 (SCL-92).

These assessments occur at the start, after 2 weeks, the day before surgery (after 5 weeks), and 2 months post-surgery.

4 surgery

The planned hip or knee surgery is performed. The study focuses on the feasibility of discontinuing or reducing medication around this time.

5 post-surgery follow-up

Two months after surgery, the use of SSRIs or SNRIs is evaluated to determine if discontinuation or dose reduction was successful.

The study aims to understand the proportion of patients who can discontinue or reduce their medication during this period.

Who Can Join the Study?

  • Must be 18 years of age or older at the time of joining the study.
  • Scheduled for a primary unilateral THA/TKA/UKA, which means a planned surgery for a hip or knee replacement on one side.
  • Currently taking SSRI/SNRI medications, which are types of antidepressants, in any dose. These medications are usually in tablet or capsule form.
  • Must be able to understand written and spoken Danish.
  • Must have signed a written informed consent form, which means agreeing to participate in the study after being informed about it.

Who Cannot Join the Study?

  • Patients who are not diagnosed with hip and knee osteoarthritis cannot participate. Osteoarthritis is a condition that affects the joints, causing pain and stiffness.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not undergoing hip or knee replacement surgery cannot participate. Arthroplasty is a type of surgery to replace or repair a joint.
  • Patients who are not taking SSRIs or SNRIs cannot participate. These are types of medications used to treat depression and anxiety.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Næstved Hospital Næstved Denmark
Odense University Hospital Odense Denmark
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Aalborg University Hospital Aalborg Denmark
Haqveqna Hscvjvox Hvidovre Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
01.04.2024

Trial locations

Investigated drugs:

Serotonin Reuptake Inhibitors (SSRIs) are a group of medications commonly used to treat depression and anxiety. They work by increasing the levels of serotonin, a natural substance in the brain that helps maintain mental balance. In this trial, the focus is on temporarily stopping these medications to see if it is feasible and to monitor any effects on the patient’s mental health, such as withdrawal symptoms or a return of depression and anxiety symptoms.

Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) are another type of medication used to treat depression and anxiety. They function by increasing the levels of serotonin and norepinephrine, which are chemicals in the brain that help regulate mood. The trial aims to assess the possibility of temporarily discontinuing these medications in patients undergoing hip or knee surgery, while observing any potential withdrawal effects or recurrence of mental health issues.

Investigated diseases:

Hip and knee osteoarthritis – This is a degenerative joint disease that affects the cartilage in the hip and knee joints. Over time, the cartilage wears down, leading to pain, stiffness, and reduced mobility. The condition progresses gradually, with symptoms worsening as the cartilage continues to deteriorate. Patients may experience swelling and a grating sensation in the affected joints. As the disease advances, it can lead to significant discomfort and difficulty in performing daily activities. The progression can vary among individuals, with some experiencing rapid deterioration and others having a slower progression.

Trial ID:
2023-509988-24-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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