Feasibility of short-term temporary discontinuation of serotonin reuptake inhibitors in patients planned for hip or knee arthroplasty

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sygehus Lillebaelt Vejle Sygehus

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2024-03-25

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Prophylaxis

To investigate the feasibility of short-term temporary discontinuation of SSRIs and SNRIs in a selected group of hip and knee arthroplasty patients with a focus on discontinuation syndrome and relapse of depression and anxiety

Conditions and MedDRA coding

Hip and knee osteoarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 18 years of age or older at the time of inclusion
2. Planed for primary unilateral THA/TKA/UKA
3. Oral treatment with SSRI/SNRI*-tablet(s)/capsule(s) in any dose (*ATC codes: N06AB04, N06AB06, N06AB10, N06AB05, N06AX21)
4. Understand written and spoken Danish language
5. Signed written informed consent form

Exclusion criteria 8

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of patients planned for THA/TKA/UKA in SSRI/SNRI therapy, who are able to discontinue SSRI/SNRI therapy perioperatively.

Secondary endpoints 5

1. 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.
2. 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.
3. 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.
4. The proportion of patients planned for THA/TKA/UKA in SSRI/SNRI therapy, who uses SSRIs/SNRIs 2 months after surgery.
5. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sygehus Lillebaelt Vejle Sygehus

Sponsor organisation

Sygehus Lillebaelt Vejle Sygehus

Address

Kabbeltoft 25

City

Vejle

Postcode

7100

Country

Denmark

Scientific contact point

Organisation

Sygehus Lillebaelt Vejle Sygehus

Contact name

Claus Varnum

Public contact point

Organisation

Sygehus Lillebaelt Vejle Sygehus

Contact name

Claus Varnum

Third parties 1

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications