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Study Comparing Antipsychotic Dose Reduction vs. Maintenance Treatment in Patients With Schizophrenia Spectrum Disorder: a Personalized Medicine Approach

NCT07152184 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-09-15

No results posted yet for this study

Summary

The objective of this study is to respond to frequent requests from patients who wish to reduce or even stop their antipsychotic treatment once they have achieved clinical stability. Psychiatrists are reluctant to respond to these requests because the method for safely reducing or stopping antipsychotic treatment remains poorly understood.

The investigators want to verify the existence of an interaction between treatment strategy and psychotic phenotype (cycloid psychosis vs. non-CP), i.e., in terms of functional remission, the benefit of the dose reduction strategy compared to the maintenance strategy will be greater in the CP group than in the non-CP group.

To this end, patients will be randomly assigned to four groups based on their phenotype and treatment strategy (CP-dose reduction; CP-dose maintenance; non-CP-dose reduction; and non-CP-dose maintenance).

Several hospitals throughout France are participating in this study, in which a random draw (called randomization) will be conducted to determine whether the physician will propose reducing the antipsychotic dose or maintaining it at the same dose for the patient.

Patients included in this study will be adults aged 18 to 60 who have been diagnosed with a schizophrenic spectrum disorder (SS): schizophrenia, schizophreniform disorder, schizoaffective disorder, or brief psychotic episode.

The antipsychotics studied are:

* second-generation antipsychotics: amisulpride, aripiprazole, olanzapine, quetiapine, risperidone;
* first-generation antipsychotics: chlorpromazine, flupentixol, haloperidol, levomepromazine, loxapine, pipotiazine, zuclopenthixol.

288 patients will be included and followed for 24 months. The inclusion period is 48 months.

Fourteen follow-up visits are planned, every month for four months and then every two months. During these visits, self-questionnaires or cognitive tests will have to be completed by the patient, the caregiver, and/or the treating psychiatrist.

Three blood samples will be taken at inclusion, at 6 months, and at the end of the study, in particular to measure the level of medication in the blood.

Conditions

  • Patient With Schizophrenia Spectrum Disorder
  • NLM Classification WM 203, Psychology:Schizophrenic Psychology
  • Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

DRUG

Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup

Biological A blood sample of up to 5 mL will be taken at visits V0, V5, and V14, for a maximum total volume of 15 mL for the study. Behavioral Quality of life and disease assessment questionnaires will need to be completed by the patient and their caregiver.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2032-02-01
Completion
2032-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07152184 on ClinicalTrials.gov