BridgeMD
A prospective, randomized, and controlled study comparing two treatment strategies (Dose REduction of Antipsychotics vs. Maintenance treatment) in patients with schizophrenia spectrum disorder after Stratification based on patients’ psychotic PHENotype: a personalized medicine approach
EU CTIS ID: 2023-509558-80-00
What this study is testing
To assess whether an interaction exists between treatment strategy (Dose Reduction (DR) vs. Maintenance Treatment (MT)) and psychotic phenotype (Cycloid Psychosis (CP) vs. non-Cycloid Psychosis), with the hypothesis that the benefit of DR strategy compared to MT in terms of functional remission is larger in the CP than in the non-CP arm (according to both personalized and precision medicine claims).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient 18-60 years of age;
- Patient clinically stabilized, for at least 6 months, as defined by a) low intensity of positive symptoms, i.e. PANSS P1, P2 and P3 items < 4.
- Patient treated with oral antipsychotics (in mono or polytherapy, with second- or first-generation antipsychotics);
- Patients with a PSP score >70 at baseline
- Patient affiliated to health insurance (beneficiary or beneficiary’s family);
- Patient informed of the results of the preliminary medical examination;
You likely can't join if
- Patient hospitalized in a psychiatric ward;
- Patient in an exclusion period defined by another research protocol;
- Patient under guardianship (i.e. French ‘tutelle’);
- Patient with care under constraint
- Patients deprived of freedom because of a judicial measure.
- Inability to give the patient the written consent form (emergency situation)
See the full eligibility criteria
- Patient 18-60 years of age;
- Patient clinically stabilized, for at least 6 months, as defined by a) low intensity of positive symptoms, i.e. PANSS P1, P2 and P3 items < 4.
- Patient treated with oral antipsychotics (in mono or polytherapy, with second- or first-generation antipsychotics);
- Patients with a PSP score >70 at baseline
- Patient affiliated to health insurance (beneficiary or beneficiary’s family);
- Patient informed of the results of the preliminary medical examination;
- Patient able to understand the aims and risks of the research (assisted by his/her curator, if applicable (if subject under curatorship*))*Subjects under limited guardianship (i.e. French “curatelle”) can participate to the study.
- Informed consent signed by patient (with assistance of his/her curator, if applicable (if subject under curatorship*))
- Patient with a diagnosis of schizophrenia spectrum disorder (SSD): schizophrenia, schizophreniform, schizoaffective disorder or brief psychotic episode according to DSM-5;
- Patient with: a) Either a cycloid psychosis (CP) phenotype according to By-CP (score >=80%; Lozère, 2024) b) Or another (non-CP) psychotic phenotype; (By-CP score < 80%)
- Outpatient followed by an ambulatory psychiatrist;
- Patient with an identified caregiver
- Patient hospitalized in a psychiatric ward;
- Patient in an exclusion period defined by another research protocol;
- Patient under guardianship (i.e. French ‘tutelle’);
- Patient with care under constraint
- Patients deprived of freedom because of a judicial measure.
- Inability to give the patient the written consent form (emergency situation)
- Patient with a recent psychotic episode (during the last 6 months);
- Patient treated with long-acting injection of antipsychotics (due to feasibility constraints and to the fact that these treatments remain essentially proposed to non-compliant patients with high risk of acute cessation and loss to follow-up);
- Patient treated with clozapine (in mono or polytherapy – highly resistant patients, specificities of the relapses under clozapine (Luykx et al., 2020));
- Patient considered by his psychiatrists to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors);
- Neurological or severe medical condition other than psychosis;
- Pregnancy (verified by urinary test at enrollment for women of childbearing age);
- Current breastfeeding;
- Patient involved in another Investigational Medicinal Product trial;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.