Tapered discontinuation vs. maintenance therapy of antipsychotic medication in patients with first-episode schizophrenia: Obstacles, findings, and lessons learned in the terminated randomized clinical trial TAILOR

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Aim: Evidence is insufficient regarding the consequences of discontinuing vs. maintaining antipsychotic medication in patients with first-episode schizophrenia. Our aim was to examine tapered discontinuation vs. maintenance treatment regarding remission of psychotic symptoms and impact on other areas. Methods: Patients included had a diagnosis of schizophrenia, were treated with antipsychotic medication, and were in remission of psychotic symptoms. Participants were randomized to tapered discontinuation or maintenance treatment with antipsychotic medication. Assessments were undertaken at baseline and after 1-year. The primary outcome was remission of psychotic symptoms without antipsychotic medication. Results: The trial was terminated due to insufficient recruitment. In total, 29 participants were included: 14 in the tapering/discontinuation group and 15 in the maintenance group. Adherence to maintenance treatment was poor. At 1-year follow-up, remission of psychotic symptoms without antipsychotic medication for 3 months was observed in five participants in the tapering/discontinuation group and two in the maintenance group. Conclusion: Due to insufficient recruitment this study does not provide a conclusion on whether unfavorable outcomes or advantages follow tapering of antipsychotic medication. Recruitment and adherence to maintenance treatment encountered obstacles. Based on experiences from this trial, we discussed alternative study designs as consistent evidence is still needed on whether to continue or discontinue antipsychotic medication in remitted patients with first-episode schizophrenia. Clinical trial registration: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000565-23/DK, EU Clinical Trials Register—EudraCT no. 2016–000565–23.

OriginalsprogEngelsk
Artikelnummer910703
TidsskriftFrontiers in Psychiatry
Vol/bind13
ISSN1664-0640
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
We thank patients for participating in the trial and the OPUS teams for participating in recruitment and completing interventions. Maj Nielsen worked in the trial as a nurse and research assistant with recruitment and assessments. Prof. Anne Maria Giraldi provided knowledge on measurements and theories of sexual functioning. OPEN Randomize undertook the randomization. Dr. Fokko J. Nienhuis trained the assessors in the GSDS. The GCP Unit at Copenhagen University Hospital and the GCP Unit at Aalborg and Aarhus University Hospitals monitored the trial.

Funding Information:
The TAILOR trial was funded by TrygFonden in Denmark (Grant Number 109436) (MN), The Capital Region of Denmark (MN) and The Medication Fund of the Regions of Denmark (Grant Number 15/1716) (MN). The Central Denmark Region and The Capital Region of Denmark supported the study indirectly by allowing the staff to follow the tapering manual but had no other influence on the study. The funders had no role in the study design, data collection, management, analysis and interpretation of data, writing the manuscript or the decision to submit for publication.

Publisher Copyright:
Copyright © 2022 Stürup, Hjorthøj, Albert, Dolmer, Birk, Ebdrup, Eplov, Jensen, Vernal, Speyer, Mors and Nordentoft.

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