To continue or not to continue? Antipsychotic medication maintenance versus dose-reduction/discontinuation in first episode psychosis : HAMLETT, a pragmatic multicenter single-blind randomized controlled trial
(2020) In Trials 21. p.1-19- Abstract
Background: Antipsychotic medication is effective for symptomatic treatment in schizophrenia-spectrum disorders. After symptom remission, continuation of antipsychotic treatment is associated with lower relapse rates and lower symptom severity compared to dose reduction/discontinuation. Therefore, most guidelines recommend continuation of treatment with antipsychotic medication for at least 1 year. Recently, however, these guidelines have been questioned as one study has shown that more patients achieved long-term functional remission in an early discontinuation condition - a finding that was not replicated in another recently published long-term study. Methods/design: The HAMLETT (Handling Antipsychotic Medication Long-term Evaluation... (More)
Background: Antipsychotic medication is effective for symptomatic treatment in schizophrenia-spectrum disorders. After symptom remission, continuation of antipsychotic treatment is associated with lower relapse rates and lower symptom severity compared to dose reduction/discontinuation. Therefore, most guidelines recommend continuation of treatment with antipsychotic medication for at least 1 year. Recently, however, these guidelines have been questioned as one study has shown that more patients achieved long-term functional remission in an early discontinuation condition - a finding that was not replicated in another recently published long-term study. Methods/design: The HAMLETT (Handling Antipsychotic Medication Long-term Evaluation of Targeted Treatment) study is a multicenter pragmatic single-blind randomized controlled trial in two parallel conditions (1:1) investigating the effects of continuation versus dose-reduction/discontinuation of antipsychotic medication after remission of a first episode of psychosis (FEP) on personal and social functioning, psychotic symptom severity, and health-related quality of life. In total 512 participants will be included, aged between 16 and 60 years, in symptomatic remission from a FEP for 3-6 months, and for whom psychosis was not associated with severe or life-threatening self-harm or violence. Recruitment will take place at 24 Dutch sites. Patients are randomized (1:1) to: continuation of antipsychotic medication until at least 1 year after remission (original dose allowing a maximum reduction of 25%, or another antipsychotic drug in similar dose range); or gradual dose reduction till eventual discontinuation of antipsychotics according to a tapering schedule. If signs of relapse occur in this arm, medication dose can be increased again. Measurements are conducted at baseline, at 3, and 6 months post-baseline, and yearly during a follow-up period of 4 years. Discussion: The HAMLETT study will offer evidence to guide patients and clinicians regarding questions concerning optimal treatment duration and when to taper off medication after remission of a FEP. Moreover, it may provide patient characteristics associated with safe dose reduction with a minimal risk of relapse. Trial status: Protocol version 1.3, October 2018. The study is active and currently recruiting patients (since September 2017), with the first 200 participants by the end of 2019. We anticipate completing recruitment in 2022 and final assessments (including follow-up 3.5 years after phase one) in 2026. Trial registration: European Clinical Trials Database, EudraCT number 2017-002406-12. Registered 7 June 2017.
(Less)
- author
- publishing date
- 2020-02-07
- type
- Contribution to journal
- publication status
- published
- keywords
- Antipsychotic medication, first episode psychosis, Discontinuation, Maintenance, Randomized controlled trial, Tapering, global functioning, Treatment
- in
- Trials
- volume
- 21
- article number
- 147
- pages
- 1 - 19
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:32033579
- scopus:85079082763
- ISSN
- 1745-6215
- DOI
- 10.1186/s13063-019-3822-5
- language
- English
- LU publication?
- no
- additional info
- Publisher Copyright: © 2020 The Author(s).
- id
- 535e77a4-e52d-4712-aedc-1d3cc9069056
- date added to LUP
- 2024-10-21 10:52:05
- date last changed
- 2025-06-03 18:28:44
@article{535e77a4-e52d-4712-aedc-1d3cc9069056,
abstract = {{<p>Background: Antipsychotic medication is effective for symptomatic treatment in schizophrenia-spectrum disorders. After symptom remission, continuation of antipsychotic treatment is associated with lower relapse rates and lower symptom severity compared to dose reduction/discontinuation. Therefore, most guidelines recommend continuation of treatment with antipsychotic medication for at least 1 year. Recently, however, these guidelines have been questioned as one study has shown that more patients achieved long-term functional remission in an early discontinuation condition - a finding that was not replicated in another recently published long-term study. Methods/design: The HAMLETT (Handling Antipsychotic Medication Long-term Evaluation of Targeted Treatment) study is a multicenter pragmatic single-blind randomized controlled trial in two parallel conditions (1:1) investigating the effects of continuation versus dose-reduction/discontinuation of antipsychotic medication after remission of a first episode of psychosis (FEP) on personal and social functioning, psychotic symptom severity, and health-related quality of life. In total 512 participants will be included, aged between 16 and 60 years, in symptomatic remission from a FEP for 3-6 months, and for whom psychosis was not associated with severe or life-threatening self-harm or violence. Recruitment will take place at 24 Dutch sites. Patients are randomized (1:1) to: continuation of antipsychotic medication until at least 1 year after remission (original dose allowing a maximum reduction of 25%, or another antipsychotic drug in similar dose range); or gradual dose reduction till eventual discontinuation of antipsychotics according to a tapering schedule. If signs of relapse occur in this arm, medication dose can be increased again. Measurements are conducted at baseline, at 3, and 6 months post-baseline, and yearly during a follow-up period of 4 years. Discussion: The HAMLETT study will offer evidence to guide patients and clinicians regarding questions concerning optimal treatment duration and when to taper off medication after remission of a FEP. Moreover, it may provide patient characteristics associated with safe dose reduction with a minimal risk of relapse. Trial status: Protocol version 1.3, October 2018. The study is active and currently recruiting patients (since September 2017), with the first 200 participants by the end of 2019. We anticipate completing recruitment in 2022 and final assessments (including follow-up 3.5 years after phase one) in 2026. Trial registration: European Clinical Trials Database, EudraCT number 2017-002406-12. Registered 7 June 2017.</p>}},
author = {{Begemann, Marieke J.H. and Thompson, Ilse A. and Veling, Wim and Gangadin, Shiral S. and Geraets, Chris N.W. and Van 'T Hag, Erna and Müller-Kuperus, Sanne J. and Oomen, Priscilla P. and Voppel, Alban E. and Van Der Gaag, Mark and Kikkert, Martijn J. and Van Os, Jim and Smit, H. Filip E. and Knegtering, Rikus H. and Wiersma, Sybren and Stouten, Luyken H. and Gijsman, Harm J. and Wunderink, Lex and Staring, Anton B.P. and Veerman, Selene R.T. and Mahabir, Amrita G.S. and Kurkamp, Jörg and Pijnenborg, Gerdina H.M. and Veen, Natalie D. and Marcelis, Machteld and Grootens, Koen P. and Faber, Gunnar and Van Beveren, Nico J. and Been, Agaath and Van Den Brink, Truus and Bak, Maarten and Van Amelsvoort, Therese A.M.J. and Ruissen, Andrea and Blanke, Christine and Groen, Karin and De Haan, Lieuwe and Sommer, Iris E.C.}},
issn = {{1745-6215}},
keywords = {{Antipsychotic medication, first episode psychosis; Discontinuation; Maintenance; Randomized controlled trial; Tapering, global functioning; Treatment}},
language = {{eng}},
month = {{02}},
pages = {{1--19}},
publisher = {{BioMed Central (BMC)}},
series = {{Trials}},
title = {{To continue or not to continue? Antipsychotic medication maintenance versus dose-reduction/discontinuation in first episode psychosis : HAMLETT, a pragmatic multicenter single-blind randomized controlled trial}},
url = {{http://dx.doi.org/10.1186/s13063-019-3822-5}},
doi = {{10.1186/s13063-019-3822-5}},
volume = {{21}},
year = {{2020}},
}