Osteo Arthritis KneeNCT04728581
Improving Sleep After TKA Using Mirtazapine and Quetiapine
A study testing Mirtazapine and Quetiapine in people with Osteo Arthritis Knee and Insomnia, run by St. Anna Ziekenhuis, Geldrop, Netherlands at 2 sites in Netherlands.
Trial summary
Use of mirtazapine and quetiapine for improvement of sleep quality after TKA Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Insomnia
- What is being tested?
- Mirtazapine and Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jan 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for TKA
Who cannot join
- use of benzodiazepines
- use of anti-depressants
- use of oxycodone
- patients diagnosed with obstructive sleep apnea syndrome, severe respiratory insufficiency, or myasthenia
- a known hypersensitivity to mirtazapine, quetiapine and/or related to the gelatinous (placebo) capsule
- insufficient understanding of the Dutch language.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michiel Siebelt contact
Netherlands2 sites
Knowledge Center for Orthopedic Surgery, St. Anna hospital
Geldrop
St. Anna hospital
Geldrop
Walter van der Weegen, 06-34282788, w.vander.weegen@st-anna.nl
About this study
Official title: Mirtazapine and Quetiapine as Treatment for Postoperative Sleep Disturbance After Fast-track Knee Replacement
Use of mirtazapine and quetiapine for improvement of sleep quality after TKA
Read the detailed description
Background After knee replacement surgery there is a loss of quantity and quality of sleep. Loss of sleep is associated with increased pain perception. Subsequently, patients use more analgesic medication and it takes them longer to fully recover from surgery. Low doses of the tetracyclic antidepressant mirtazapine and the neuroleptic quetiapine are nowadays off-label prescribed for insomnia and improve length and quality of deep sleep phases. Quetiapine and mirtazapine could improve sleep after knee replacement surgery and improve patient recovery. This placebo-controlled, randomized, double-blind study investigates the effect of quetiapine and mirtazapine on functional recovery after total knee arthroplasty.
Methods This is a prospective, single center, double-blinded randomized controlled trial. 165 patients with knee osteoarthritis scheduled for total knee arthroplasty will be randomly allocated to a low-dose quetiapine (LDQ), a low-dose mirtazapine (LDM) group or a placebo group. Outcomes will be evaluated at baseline, 2, 4, 6 and 12 weeks after surgery. Functional outcome after total knee arthroplasty is measured using a patient related outcome measure through the Oxford Knee Score (OKS). In order to measure postoperative sleep quality, patients will be monitored using the Leeds Sleep evaluation questionnaire (LSEQ). Furthermore, pain is registered using a visual analogue scale (VAS), weekly opioid use is monitored, and general health status is reported through the EQ-5D. Analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models. This trial complies with the SPIRIT guidelines for randomized controlled trials.
Discussion This study will provide clinicians with evidence whether quetiapine contributes to rehabilitation of patients undergoing fast-track knee replacement surgery.
- Conditions
- Osteo Arthritis Knee, Insomnia
- Being tested
- Mirtazapine, Quetiapine, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
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.
QuetiapineDrug
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.
PlaceboDrug
a gelatinous capsule without an active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | use of placebo during first 2 weeks after TKA surgery Receives: Drug: Placebo |
| Low dose Mirtazapine | Experimental | Use of Mirtazapine 3.75mg before lights-out, allowed to increase medication to 7.5mg Receives: Drug: Mirtazapine |
| Low dose Quetiapine | Experimental | use of Quetiapine 3.125mg before lights-out, allowed to increase medication to 6.25mg Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score (OKS)
Validated functional knee score after TKA, minimum score 12 (best outcome), maximum score 60 (worst outcome)
Measured: 6 weeks after surgery
Secondary outcomes (8)
Leeds Sleep Evaluation questionnaire (LSEQ)
Validated sleep score in 3 dimensions of sleep
Measured: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Visual Analogue Scale (VAS) for fatigue
Visual analogue reporting of fatigue after sleep, indicated on a 0 (best outcome) to 100 (worst outcome) mm line
Measured: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Visual Analogue Scale (VAS) for sleep quality
Visual analogue reporting of quality sleep, indicated on a 0 (worst outcome) to 100 (best outcome) mm line
Measured: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Visual Analogue Scale (VAS) for pain in rest
Visual analogue reporting of knee pain while resting, indicated on a 0 (best outcome) to 100 (worst outcome) mm line
Measured: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Visual Analogue Scale (VAS) for pain during activity
Visual analogue reporting of knee pain during exercises, indicated on a 0 (best outcome) to 100 (worst outcome) mm line
Measured: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
EuroQol (EQ) 5D
General well being score, full health represented by 11111 score (overall score for the Netherlands of 1,000), worst health represented by 55555 score (overal score for the Netherlands of -0,329)
Measured: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Morphine use
Total amount (mg) morphine use after surgery is documented
Measured: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Oxford knee score
Validated functional knee score after TKA, minimum score 12 (best outcome), maximum score 60 (worst outcome)
Measured: 1 week before surgery; first day postoperative; 2; 4; 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Jan 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Anna Ziekenhuis, Geldrop, Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728581
- Sponsor's protocol ID
- W021-001
- Status last verified
- Jun 2023
- First submitted
- 12 Jan 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data free accessible upon request
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirtazapine and Quetiapine as Treatment for Postoperative Sleep Disturbance After Fast-track Knee Replacement
- ClinicalTrials.gov ID
- NCT04728581
- Acronym / sponsor ID
- W021-001
- Conditions
- Osteo Arthritis Knee, Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- St. Anna Ziekenhuis, Geldrop, NetherlandsUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of mirtazapine and quetiapine for improvement of sleep quality after TKA
Detailed description
Background After knee replacement surgery there is a loss of quantity and quality of sleep. Loss of sleep is associated with increased pain perception. Subsequently, patients use more analgesic medication and it takes them longer to fully recover from surgery. Low doses of the tetracyclic antidepressant mirtazapine and the neuroleptic quetiapine are nowadays off-label prescribed for insomnia and improve length and quality of deep sleep phases. Quetiapine and mirtazapine could improve sleep after knee replacement surgery and improve patient recovery. This placebo-controlled, randomized, double-blind study investigates the effect of quetiapine and mirtazapine on functional recovery after total knee arthroplasty.
Methods This is a prospective, single center, double-blinded randomized controlled trial. 165 patients with knee osteoarthritis scheduled for total knee arthroplasty will be randomly allocated to a low-dose quetiapine (LDQ), a low-dose mirtazapine (LDM) group or a placebo group. Outcomes will be evaluated at baseline, 2, 4, 6 and 12 weeks after surgery. Functional outcome after total knee arthroplasty is measured using a patient related outcome measure through the Oxford Knee Score (OKS). In order to measure postoperative sleep quality, patients will be monitored using the Leeds Sleep evaluation questionnaire (LSEQ). Furthermore, pain is registered using a visual analogue scale (VAS), weekly opioid use is monitored, and general health status is reported through the EQ-5D. Analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models. This trial complies with the SPIRIT guidelines for randomized controlled trials.
Discussion This study will provide clinicians with evidence whether quetiapine contributes to rehabilitation of patients undergoing fast-track knee replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebouse of placebo during first 2 weeks after TKA surgery |
| Low dose Mirtazapine | Experimental | Drug: MirtazapineUse of Mirtazapine 3.75mg before lights-out, allowed to increase medication to 7.5mg |
| Low dose Quetiapine | Experimental | Drug: Quetiapineuse of Quetiapine 3.125mg before lights-out, allowed to increase medication to 6.25mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for TKA
Key exclusion criteria (6 listed)
- use of benzodiazepines
- use of anti-depressants
- use of oxycodone
- patients diagnosed with obstructive sleep apnea syndrome, severe respiratory insufficiency, or myasthenia
- a known hypersensitivity to mirtazapine, quetiapine and/or related to the gelatinous (placebo) capsule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirtazapineUse 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 | Low dose Mirtazapine |
| QuetiapineUse 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 | Low dose Quetiapine |
| Placeboa gelatinous capsule without an active ingredient | Drug | Placebo |
Primary outcome
Oxford Knee Score (OKS)
Time frame: 6 weeks after surgery
Validated functional knee score after TKA, minimum score 12 (best outcome), maximum score 60 (worst outcome)
8 secondary outcomes
Leeds Sleep Evaluation questionnaire (LSEQ)
Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Visual Analogue Scale (VAS) for fatigue
Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Visual Analogue Scale (VAS) for sleep quality
Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Visual Analogue Scale (VAS) for pain in rest
Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Visual Analogue Scale (VAS) for pain during activity
Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
EuroQol (EQ) 5D
Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Morphine use
Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery
Oxford knee score
Time frame: 1 week before surgery; first day postoperative; 2; 4; 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Yes. All data free accessible upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michiel Siebelt contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirtazapine and Quetiapine in people with Osteo Arthritis Knee and Insomnia, run by St. Anna Ziekenhuis, Geldrop, Netherlands at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter van der Weegen (06-34282788, w.vanderweegen@st-anna.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Knee Score (OKS) (time frame: 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.