Status:
COMPLETED
Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia
Lead Sponsor:
Prague Psychiatric Center
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 tr...
Detailed Description
Title of Study: ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia. Estimated Number of Study Centers an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00712660
Start Date
November 1 2008
End Date
March 1 2012
Last Update
April 2 2013
Active Locations (1)
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1
Prague Psychiatric Center
Prague, Ustavni, Czechia, 181 03