A RCT Study in Schizophrenia Relapse Prevention

Relapse Schizophrenia Clinical Trial

Official title:

Prospective, Randomized, Open, Controlled Study With Information and Telecommunication Technology-aided Relapse Prevention Program in Schizophrenia.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01885923
• Other study ID #: ITAREPS 2.0
• Secondary ID: NT/13292 - 3
• Status: Unknown status
• Phase: N/A
• First received: August 14, 2012
• Last updated: July 10, 2013
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2013
• Source: Prague Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in ITAREPS will demonstrate statistically significantly reduced risk of hospitalization, decreased number of hospitalization days and reduced direct inpatient costs in comparison to control group not using the program.

Description:

The ITAREPS 2.0 program employs telecommunication and information technologies in order to detect fluctuations in longitudinal mental health status of patient with schizophrenia and thus signalize the very early stages of prodromes preceding relapse. This approach opens an avenue towards early pharmacological intervention. Subjects (150 patients with diagnosis of schizophrenia and schizoaffective disorder and their family members) will be randomized at a 1:1 ratio into the active or control group. Participants from the active group will be completing two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request generated automatically by the system during 18 months study duration. In this group, automatically generated e-mail alert message feedback to the investigator will be activated in case of prodrome detection, prompting investigator to antipsychotic dose increase by 20%. The control (treatment-as-usual) group will not use ITAREPS system.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

For entry into the study, the following criteria MUST be met:

• Men and women, ages 18 to 60 years, inclusive.

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

• Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.

• Severity (CGI-S) = 3 at study Visit 1.

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

Exclusion Criteria:

• Organic mental disorder,

• mental disorder due to psychoactive substance use or mental retardation.

• Participation in another relapse prevention program.

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

Related Conditions & MeSH terms

• Recurrence
• Relapse Schizophrenia
• Schizophrenia

Intervention

Device:
• ITAREPS
Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia)

Locations

Country	Name	City	State
Czech Republic	Prague Psychiatric Center	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Prague Psychiatric Center

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.		18 months
Secondary	Number of psychiatric hospitalization days		18months
Secondary	Direct impatient costs		18months
Secondary	Direct cost of outpatient antipsychotic medication		18months
Secondary	Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups		18months

External Links

•   study web pages