Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia
Schizophrenia
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring prevention, relapse, schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Men and women, ages 18 to 60 years, inclusive. Earliest inclusion day is the 18th birthday and the latest is the day before the 61st birthday.
- A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
- Increased risk for relapse, defined as having at least 1 psychiatric hospitalization for psychosis within the past 3 years and at least 2 psychiatric hospitalizations for psychosis in total (i.e. ≥ 2 hospitalizations).
- Clinical Global Impression scale - Severity (CGI-S) ≤ 3 at study Visit 1.
- All patients must be on stable doses of antipsychotic medication during the study entry.
- Absence of organic mental disorder, mental disorder due to psychoactive substance use or mental retardation.
- Presence of a cooperating family member, caregiver or other person who is in frequent contact with the patient (at least 4 times a week) and who is willing to participate in the trial.
- Signed written informed consent. The informed consent process must be documented by signing the informed consent form prior to any study-related procedures.
- Eligibility for mobile phone communicating.
Exclusion Criteria:
- Participation in another relapse prevention program or another interventional clinical trial will be prohibited during the entire participation in the study. Subjects enrolled in observational (non-interventional) trials are not excluded from this study.
- Hayward compliance rating scale score < 2 at Visit 1.
Sites / Locations
- Prague Psychiatric Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
A
TAU
In the active-ITAREPS group, the e-mail ALERT message feedback to the investigator will be activated. The core study intervention was 20% antipsychotic dose increase within 24 hours in response to a Pharmacological Intervention Requiring Event (PIRE) defined as either: A) the receipt of any INITIAL ALERT (IA) e-mail. A dose increase was obligatory in such cases regardless of the current clinical status of the patient; or B) the receipt of an ALERT EMERGENCY (AE) e-mail after which the investigator confirmed clinical worsening via phone contact with the patient. AE is defined as further worsening in EWSQ scores during 3 week period after announcement of IA.
In the treatment-as-usual study arm (control, non-active ITAREPS), the e-mail ALERT message feedback will not be activated. In this group, even in the presence of early warning sings, the investigators will be kept blinded to the EWSQ scores, will receive no ALERT message and thus no early pharmacologic intervention based on the ITAREPS program will be prompted. Treatment in the control group will consist of routine clinical and medication management with the frequency of visits common in the outpatient clinical settings. There will be no intevention based on ITAREPS.