Table of contents
- Trial overview
- Who is studied
- Treatment strategies being compared
- Study phase and size
- Main outcomes being measured
- What this trial is trying to learn
Trial overview
The main trial in the data is HAMLETT, which stands for Handling Antipsychotic Medication: Long-term Evaluation of Targeted Treatment.[1] It is an interventional study, which means researchers assign treatment strategies and then compare the results.[1]
This study looks at people who are in remission after a first episode of psychosis and compares continuing antipsychotic medication with early dose reduction or stopping treatment.[1] Haloperidol is one of the antipsychotic medicines listed in the study interventions.[1]
Who is studied
The target group is patients who have recovered from a first episode of psychosis.[1] In simple terms, this means people whose first psychotic episode has improved enough to be considered in remission.[1]
The study is designed to help understand what happens after recovery, especially for people who may be deciding whether to stay on medication or lower the dose.[1]
Treatment strategies being compared
The trial compares continuation of antipsychotic medication for at least one year with early dose reduction/discontinuation.[1] Dose reduction means using less medicine, and discontinuation means stopping it.[1]
Several antipsychotic medicines are listed in the intervention set, including Haloperidol, Clozapine, Tiapride, Sertindole, Paliperidone, Olanzapine, Sulpiride, Aripiprazole, Lurasidone, Risperidone, Amisulpride, Chlorpromazine, Pimozide, and Quetiapine.[1] The trial is not focused on one single medicine only; it is testing treatment management after remission.[1]
Study phase and size
HAMLETT is a Phase 3 trial.[1] Phase 3 studies usually test a treatment strategy in a larger group and compare outcomes in a more practical setting.[1]
The planned enrollment is 444 participants.[1] The trial status is listed as authorised.[1]
Main outcomes being measured
The primary outcome is based on what patients and their relatives said was most important in a survey by Anoiksis, a Dutch patient organisation.[1] This outcome focuses on long-term social recovery, which is how well a person returns to normal life roles, relationships, and activities.[1]
The main measurement tool is the World Health Organization Disability Assessment Schedule, also called WHODAS-II.[1] WHODAS-II measures disability and how well someone manages daily life and social functioning.[1]
The brief summary also says the study looks at personal and social functioning over short-term periods such as 1 to 2 years, and longer-term periods such as 3 to 4 years.[1]
What this trial is trying to learn
This trial is trying to answer a practical question after recovery from psychosis: should antipsychotic treatment be continued, reduced, or stopped?[1] The main goal is not just symptom control, but also how well people function in daily and social life over time.[1]
Because the study includes patient-important outcomes, it reflects what patients and families consider meaningful in real life.[1] That makes the trial especially focused on recovery beyond symptoms alone.[1]
