NCT04728581

Brief Summary

Use of mirtazapine and quetiapine for improvement of sleep quality after TKA

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2024Jan 2027

First Submitted

Initial submission to the registry

January 12, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

June 2, 2023

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

January 12, 2021

Last Update Submit

June 1, 2023

Conditions

Osteo Arthritis KneeInsomnia

Outcome Measures

Primary Outcomes (1)

  • Oxford Knee Score (OKS)

    Validated functional knee score after TKA, minimum score 12 (best outcome), maximum score 60 (worst outcome)

    6 weeks after surgery

Secondary Outcomes (8)

  • Leeds Sleep Evaluation questionnaire (LSEQ)

    1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

  • Visual Analogue Scale (VAS) for fatigue

    1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

  • Visual Analogue Scale (VAS) for sleep quality

    1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

  • Visual Analogue Scale (VAS) for pain in rest

    1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

  • Visual Analogue Scale (VAS) for pain during activity

    1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

  • +3 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

use of placebo during first 2 weeks after TKA surgery

Drug: Placebo

Low dose Mirtazapine

EXPERIMENTAL

Use of Mirtazapine 3.75mg before lights-out, allowed to increase medication to 7.5mg

Drug: Mirtazapine

Low dose Quetiapine

EXPERIMENTAL

use of Quetiapine 3.125mg before lights-out, allowed to increase medication to 6.25mg

Drug: Quetiapine

Interventions

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.

Low dose 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.

Low dose Quetiapine
PlaceboDRUG

a gelatinous capsule without an active ingredient

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for TKA

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Knowledge Center for Orthopedic Surgery, St. Anna hospital

Geldrop, Netherlands

Location

St. Anna hospital

Geldrop, Netherlands

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

MirtazapineQuetiapine Fumarate

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic Chemicals

Central Study Contacts

Walter van der Weegen

CONTACT

06-34282788w.vanderweegen@st-anna.nl

Michiel Siebelt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Placebo controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 28, 2021

Study Start

January 1, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

June 2, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

All data free accessible upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
First year after publication
Access Criteria
After written request, and received permission

Locations

NL(2)