Study on Reducing Antipsychotic Dose vs. Maintenance Treatment for Patients with Schizophrenia Using Haloperidol Decanoate, Risperidone, and Amisulpride
This clinical trial is investigating two different treatment approaches for patients with schizophrenia spectrum disorders, including schizophrenia, schizophreniform disorder, schizoaffective disorder, and brief psychotic episodes. The study compares the effectiveness of reducing antipsychotic medication doses against maintaining the current treatment dose over a period of up to 24 months.
Main inclusion criteria:
- Patients aged between 18 and 60 years
- Clinically stable for at least 6 months with low symptom levels
- Currently taking oral antipsychotic medications
- Personal and Social Performance Scale score greater than 70, indicating good daily functioning
- Confirmed diagnosis of schizophrenia spectrum disorder
- Receiving outpatient care from a psychiatrist
- Has an identified caregiver for support
- Covered by health insurance
Main exclusion criteria:
- Patients without a diagnosis of schizophrenia spectrum disorder
- Patients outside the specified age range
- Patients considered part of a vulnerable population requiring special protection
Focus and goals: The trial aims to determine whether personalized treatment strategies based on the type of psychotic symptoms a patient experiences can improve outcomes. Participants will be randomly assigned to either dose reduction or maintenance treatment groups, with assignment partly based on their psychotic symptom pattern. The study will monitor how well patients function in daily life using regular assessments, including the Personal and Social Performance Scale, Clinical Global Impression scale, and web-based evaluations with caregivers. The ultimate goal is to identify the most effective management approach while minimizing side effects and improving quality of life.
Investigational drugs: The study involves several antipsychotic medications, including haloperidol decanoate, risperidone, and amisulpride as the primary drugs. Additional medications used in the trial include loxapine succinate, flupentixol decanoate, pregabalin, chlorpromazine hydrochloride, levomepromazine hydrochloride, aripiprazole, pipotiazine palmitate, and fluoxetine hydrochloride. These medications work by affecting the balance of brain chemicals, particularly dopamine, to help reduce symptoms such as hallucinations, delusions, and disorganized thinking.