Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT05886504
Eligibility Criteria:
Inclusion Criteria:
Drive Mind II Psychiatric intervention group:
Participants of the ANRS 12353/National Institue of Drug Abuse (NIDA) Region of Interest (ROI) DA 041978 DRIVE study (age \> 18 years; positive urine test for heroin and/or methamphetamine \& skin marks of injection) who either:
* participated to the DRIVE Mind I cohort
* were candidate for the DM II control group but were diagnosed at inclusion with a major depressive disorder, psychotic disorder or suicide risk (MINI semi-structured interview) or any other significant psychiatric disorder requiring support and treatment (clinical diagnosis of a psychiatrist);
* participants recruited in the control group diagnosed at any step of the one-year follow-up with a major depressive disorder, a psychotic disorder or suicide risk (MINI semi-structured interview) or any other significant psychiatric disorder requiring support and treatment (clinical diagnosis of a psychiatrist) at M6 will be proposed to join the psychiatric cohort;
* Signed informed consent form. Participants eligible for the DM II cohort but refusing the principle of a treatment will nevertheless be included in the psychiatric cohort for follow-up, counselling and support except if the severity of the clinical situation requires immediate hospitalization in the mental health department.
Drive Mind II control group
Participants of the ANRS 12353/NIDA ROI DA 041978 DRIVE study (age \> 18 years; positive urine test for heroin and/or methamphetamine \& skin marks of injection):
* who participated to the DRIVE M30 survey and
* were screened negative for a potential psychiatric disorder at DRIVE M30 visit (Quick screening tool, QST) and
* are free of a major depressive disorder, a psychotic disorder or suicide risk (MINI semi-structured interview) or any other significant psychiatric disorder requiring support and treatment (clinical diagnosis of a psychiatrist) at DM II cohort initiation
* Signed informed consent form. Recruitment in the control group will take place until 200 HIV+ and 200 HIV- are enrolled
Exclusion Criteria:
* Severe psychiatric condition at cohort initiation requiring immediate hospitalization in the mental health department
* Severe associated diseases requiring specific treatment incompatible with a psychiatric ambulatory follow-up and treatment;
* Any condition which might, in the investigator's opinion, compromise the safety of the patient by participating in the study including very severe clinical condition;
* Contraindication for treatment with mirtazapine, sertraline, risperidone, olanzapine, sulpiride, quetiapine, melatonine;
* Person deprived of freedom by a judicial or administrative decision;
* Person who plan to move out from Hai Phong in the next 12 months;
* Person unable to understand the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05886504
Study Brief:
Protocol Section:
NCT05886504