A RCT Study in Schizophrenia Relapse Prevention

Prague Psychiatric Center150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Relapse Schizophrenia

Interventions

ITAREPSDEVICE

Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Prague Psychiatric Center

Prague, Czechia

Outcomes

Primary Outcomes

Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.

Time frame: 18 months

Secondary Outcomes

Number of psychiatric hospitalization days

Time frame: 18months

Direct impatient costs

Time frame: 18months

Direct cost of outpatient antipsychotic medication

Time frame: 18months

Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups

Time frame: 18months

Data from ClinicalTrials.gov

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