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

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 guidelin...

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Published in:	Current controlled trials in cardiovascular medicine Vol. 21; no. 1; pp. 147 - 19
Main Authors:	Begemann, Marieke J H, Thompson, Ilse A, Veling, Wim, Gangadin, Shiral S, Geraets, Chris N W, van 't Hag, Erna, Müller-Kuperus, Sanne J, Oomen, Priscilla P, Voppel, Alban E, van der Gaag, Mark, Kikkert, Martijn J, Van Os, Jim, Smit, H Filip E, Knegtering, Rikus H, Wiersma, Sybren, Stouten, Luyken H, Gijsman, Harm J, Wunderink, Lex, Staring, Anton B P, Veerman, Selene R T, Mahabir, Amrita G S, Kurkamp, Jörg, Pijnenborg, Gerdina H M, Veen, Natalie D, Marcelis, Machteld, Grootens, Koen P, Faber, Gunnar, van Beveren, Nico J, Been, Agaath, van den Brink, Truus, Bak, Maarten, van Amelsvoort, Therese A M J, Ruissen, Andrea, Blanke, Christine, Groen, Karin, de Haan, Lieuwe, Sommer, Iris E C
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 07-02-2020 BioMed Central BMC
Subjects:	Adolescent Adult Antipsychotic agents Antipsychotic Agents - administration & dosage Antipsychotic Agents - standards Antipsychotic medication, first episode psychosis Antipsychotics Care and treatment Clinical outcomes Clinical trials Cognition & reasoning Comparative analysis Discontinuation Dopamine Dose-Response Relationship, Drug Drug Administration Schedule Drug dosages Female Follow-Up Studies Humans Maintenance Male Medical research Middle Aged Multicenter Studies as Topic Practice Guidelines as Topic Pragmatic Clinical Trials as Topic Psychosis Psychotic Disorders - diagnosis Psychotic Disorders - drug therapy Psychotropic drugs Quality of Life Randomized controlled trial Remission (Medicine) Remission Induction - methods Schizophrenia Severity of Illness Index Single-Blind Method Study Protocol Suicides & suicide attempts Tapering, global functioning Treatment Treatment Outcome Violence Young Adult Netherlands Tapering, global functioning Discontinuation Treatment Maintenance Antipsychotic medication, first episode psychosis Randomized controlled trial
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Summary:	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. 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. 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. 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. European Clinical Trials Database, EudraCT number 2017-002406-12. Registered 7 June 2017.
ISSN:	1745-6215 1745-6215
DOI:	10.1186/s13063-019-3822-5