Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will decrease the number of hospitalizations in patients with schizophrenia or schizoaffective disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction of the total number of hospitalizations due to relapse of psychosis at the end of the 12-months follow-up period in the active ITAREPS group compared to the control (treatment-as-usual) group.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prague Psychiatric Center
• Collaborator: Eli Lilly and Company
• Treatments: Antipsychotic Agents

Criteria

Inclusion Criteria:

1. 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.

2. A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.

3. 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).

4. Clinical Global Impression scale - Severity (CGI-S) ≤ 3 at study Visit 1.

5. All patients must be on stable doses of antipsychotic medication during the study entry.

6. Absence of organic mental disorder, mental disorder due to psychoactive substance use or mental retardation.

7. 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.

8. Signed written informed consent. The informed consent process must be documented by signing the informed consent form prior to any study-related procedures.

9. Eligibility for mobile phone communicating.

Exclusion Criteria:

1. 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.

2. Hayward compliance rating scale score < 2 at Visit 1.