In short
Clinical trials investigating Haloperidol are studying treatment strategies for people who have recovered from a first episode of psychosis. These trials look at whether continuing antipsychotic treatment or reducing/stopping it affects long-term recovery, daily functioning, and social life. The main focus is on safety, effectiveness, and patient-important outcomes.
Key points
- Clinical trials investigating Haloperidol are focused on people who have recovered from a first episode of psychosis. The main study asks whether continuing antipsychotic treatment for at least one year is better than early dose reduction or stopping treatment. The trial is in Phase 3 and includes 444 participants. It measures long-term social recovery and daily functioning, using WHODAS-II as the main outcome tool. The study also looks at how treatment strategies affect personal and social functioning over both short and longer time periods. Haloperidol is one of several antipsychotic medicines included in the comparison.
Trial overview
The main trial in the data is HAMLETT, which stands for Handling Antipsychotic Medication: Long-term Evaluation of Targeted Treatment. It is an interventional study, which means researchers assign treatment strategies and then compare the results.
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. Haloperidol is one of the antipsychotic medicines listed in the study interventions.
Who is studied
The target group is patients who have recovered from a first episode of psychosis. In simple terms, this means people whose first psychotic episode has improved enough to be considered in remission.
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.
Treatment strategies being compared
The trial compares continuation of antipsychotic medication for at least one year with early dose reduction/discontinuation. Dose reduction means using less medicine, and discontinuation means stopping it.
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. The trial is not focused on one single medicine only; it is testing treatment management after remission.
Study phase and size
HAMLETT is a Phase 3 trial. Phase 3 studies usually test a treatment strategy in a larger group and compare outcomes in a more practical setting.
The planned enrollment is 444 participants. The trial status is listed as authorised.
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. This outcome focuses on long-term social recovery, which is how well a person returns to normal life roles, relationships, and activities.
The main measurement tool is the World Health Organization Disability Assessment Schedule, also called WHODAS-II. WHODAS-II measures disability and how well someone manages daily life and social functioning.
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.
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? The main goal is not just symptom control, but also how well people function in daily and social life over time.
Because the study includes patient-important outcomes, it reflects what patients and families consider meaningful in real life. That makes the trial especially focused on recovery beyond symptoms alone.