RISPERIDONE for Schizophrenia | Schizophreniform disorder | Schizoaffective disorder | Brief psychotic disorder

Stratification factors

• Psychotic phenotype (Cycloid Psychosis vs non-Cycloid Psychosis)

Inclusion criteria

• {"criterion_text":"- Patient 18-60 years of age;"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patient treated with oral antipsychotics (in mono or polytherapy, with second- or first-generation antipsychotics);"}
• {"criterion_text":"- Patients with a PSP score >70 at baseline"}
• {"criterion_text":"- Patient affiliated to health insurance (beneficiary or beneficiary’s family);"}
• {"criterion_text":"- Patient informed of the results of the preliminary medical examination;"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Informed consent signed by patient (with assistance of his/her curator, if applicable (if subject under curatorship*))"}
• {"criterion_text":"- Patient with a diagnosis of schizophrenia spectrum disorder (SSD): schizophrenia, schizophreniform, schizoaffective disorder or brief psychotic episode according to DSM-5;"}
• {"criterion_text":"- 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%)"}
• {"criterion_text":"- Outpatient followed by an ambulatory psychiatrist;"}
• {"criterion_text":"- Patient with an identified caregiver"}

Exclusion criteria

• {"criterion_text":"- Patient hospitalized in a psychiatric ward;"}
• {"criterion_text":"- Patient in an exclusion period defined by another research protocol;"}
• {"criterion_text":"- Patient under guardianship (i.e. French ‘tutelle’);"}
• {"criterion_text":"- Patient with care under constraint"}
• {"criterion_text":"- Patients deprived of freedom because of a judicial measure."}
• {"criterion_text":"- Inability to give the patient the written consent form (emergency situation)"}
• {"criterion_text":"- Patient with a recent psychotic episode (during the last 6 months);"}
• {"criterion_text":"- 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);"}
• {"criterion_text":"- Patient treated with clozapine (in mono or polytherapy – highly resistant patients, specificities of the relapses under clozapine (Luykx et al., 2020));"}
• {"criterion_text":"- Patient considered by his psychiatrists to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors);"}
• {"criterion_text":"- Neurological or severe medical condition other than psychosis;"}
• {"criterion_text":"- Pregnancy (verified by urinary test at enrollment for women of childbearing age);"}
• {"criterion_text":"- Current breastfeeding;"}
• {"criterion_text":"- Patient involved in another Investigational Medicinal Product trial;"}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with functional remission as defined by a PSP (Personal and Social Performance Scale, Nasrallah et al. 2008) score >70 at 24 months follow-up (study endpoint).","definition_or_measurement_approach":"Functional remission defined as PSP score >70 at 24 months; PSP assessment by Dreams-Phen evaluation team used for primary endpoint."}
• {"endpoint_text":"- The PSP will be assessed at different times of the study, both by the treating psychiatrist of the patients (i.e. who is not blind to patients’ treatment arm) and by the Dreams-Phen evaluation team (who will be blind to patients’ treatment arm). The primary endpoint will rely ONLY on the PSP scores at 24 months assessed by the Dreams-Phen evaluation team.","definition_or_measurement_approach":"Primary endpoint uses PSP scores at 24 months assessed by the blinded Dreams-Phen evaluation team; PSP also assessed by treating psychiatrists but those are not used for primary analysis."}
• {"endpoint_text":"- This evaluation will be performed during a webmeeting with the patient and his/her caregiver and will be based on the patient’s functioning during the month preceding the evaluation.","definition_or_measurement_approach":"PSP assessments for primary endpoint are performed via webmeeting with patient and caregiver and are based on functioning in the month preceding the assessment."}

Secondary endpoints

• {"endpoint_text":"- Functional remission as defined by a PSP (Personal and Social Performance Scale, Nasrallah et al., 2008) score >70 at 24 months follow-up (study endpoint) and as assessed by the Dreams-Phen evaluation team.","definition_or_measurement_approach":"As per primary: PSP >70 at 24 months assessed by Dreams-Phen team."}
• {"endpoint_text":"- Clinical symptoms will be assessed with the short form of the PANSS (PANSS-6) and will be used by the treating psychiatrists as well as the Dreams-Phen evaluation team at some assessment points for time purposes. Illness severity will be assessed with the Clinical Global Impression (CGI).","definition_or_measurement_approach":"PANSS-6 for symptoms; CGI for illness severity; assessments by treating psychiatrists and Dreams-Phen team at specified time points."}
• {"endpoint_text":"- A relapse will be defined by either as: a) a new hospitalization due to exacerbation of symptoms b) aggressive behavior c) suicidal attempt","definition_or_measurement_approach":"Relapse defined as any of: new hospitalization for symptom exacerbation, aggressive behavior, or suicide attempt."}
• {"endpoint_text":"- At the end of the study, a structured interview (inspired by that used in the Radar study; Moncrieff et al. 2019) will be conducted with the patients and his/her caregivers and sent to the treating psychiatrist, in order to confirm the presence or absence of any relapse during the period of the study","definition_or_measurement_approach":"Structured interview at study end with patient and caregiver to confirm relapse history; interview content based on Radar study instrument."}
• {"endpoint_text":"- Therapeutic efficacy index will be assessed with the CGI-difference and adherence to treatment with the MARS (Thompson et al., 2000) from the patient side and the BARS (Byerly et al., 2008) from the psychiatrist side. In addition, drug monitoring will be proposed, in order to check adherence to treatment and to ensure patients’ compliance to the treatment arm.","definition_or_measurement_approach":"Therapeutic efficacy: CGI-difference; adherence: MARS (patient) and BARS (psychiatrist); optional drug monitoring."}
• {"endpoint_text":"- Treatment side-effects will be assessed using the Abnormal Involuntary Movement Scale (AIMS), and Simpson & Angus Scale (SAS), and using the body mass index and biological measures to assess metabolic syndrome. Cognitive functioning will be assessed with subjective scales SSTICS and cognitive tests completed online using Millisecond softwares. Subjective well-being under antipsychotics will be assessed by means of the SWN-SF.","definition_or_measurement_approach":"Side-effects: AIMS and SAS, BMI and laboratory measures for metabolic syndrome. Cognition: SSTICS and online cognitive tests. Well-being: SWN-SF."}
• {"endpoint_text":"- Global and social functioning will be assessed using the GAF, the PSP total score and the EPHP (rated by the caregivers). Quality of life will be assessed using the S-QoL and the EQ-5D-5L (EuroQoL-5D) and the recovery process by means of the Questionnaire about the Process of Recovery (QPR).","definition_or_measurement_approach":"Functioning: GAF, PSP, EPHP. QoL: S-QoL, EQ-5D-5L. Recovery: QPR."}
• {"endpoint_text":"- The influence of specific patient characteristics on our primary outcome will be assessed, in particular, the level of interaction between treatment intervention and phenotype and: a) the history of psychotic episodes (i.e. patients with first or multiple psychotic episode(s)) b) the presence/absence of current substance abuse disorder (this will not represent an exclusion criteria); similar to Radar and Hamlett studies.","definition_or_measurement_approach":"Interaction analyses between treatment and phenotype; subgroup analyses by history of psychotic episodes and presence/absence of substance use disorder."}
• {"endpoint_text":"- Practically, if a patient presents with a transient increase of psychotic symptoms during a step X of the DR schema, we will estimate that the individual minimal effective dose (i-MinED) is that corresponding to the dose given during the previous step (X-1) in the DR protocol.","definition_or_measurement_approach":"Rule for defining individual minimal effective dose (i-MinED): previous DR step dose (X-1) if transient symptom increase at step X."}
• {"endpoint_text":"- Significant relapse and PSP, 3 months after reaching the MinED.","definition_or_measurement_approach":"Assessment of relapse and PSP score 3 months after achieving MinED."}
• {"endpoint_text":"- Mean antipsychotic dosage at study endpoint in each arm (as expressed in eqOlz and in % of D2-R occupancy)","definition_or_measurement_approach":"Mean antipsychotic dose at endpoint reported as olanzapine-equivalent and estimated % D2 receptor occupancy."}

France

Earliest CTIS Part Ii Submission Date

25-03-2025

Latest Decision Or Authorization Date

26-02-2026

Processing Time Days

338

Number Of Sites

7

Number Of Participants

288

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"National clinical research hospital program 2021 (PHRC 2021)","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"France","full_name":"Strasbourg University Hospitals","duties_or_roles":"Monetary support","organisation_type":""}