A RCT Study in Schizophrenia Relapse Prevention

July 10, 2013 updated by: Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 18103
        • Prague Psychiatric Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 20% antisychotic dose increase in prodromes
Antipsychotic dose increase upon prodromes occurence detected by Device- ITAREPS system. All antipsychotics currently registered in Czech Republic will be allowed in this study. All patients will remain on antipsychotic treatment adjusted prior enrollment, so that dose adjustment will be based on their ordinary medication. Participants will be instructed to complete the 10-item EWS Questionnaire upon SMS request sent automatically weekly to their mobile phones. EWSQ detects proportional worsening of the symptoms compared to the last week's score of the questionnaire. Individual EWSQ scores will be sent by participants back to the ITAREPS system as a SMS. If the total score exceeds the given score threshold, an immediate ALERT would be declared and announced to the investigator as an e-mail message and a therapeutic intervention is requested. After detecting the early warning signs by ITAREPS, an immediate 20% increase in the dose of antipsychotic will be required.
Device: ITAREPS
Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia)
Other Names:
  • Information Technology Aided Relaps Prevention in Schizophrenia
No Intervention: Treatment as usual
In the control group (treatment-as-usual) participants will not be enrolled in the ITAREPS system.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of psychiatric hospitalization days
Time Frame: 18months
18months
Direct impatient costs
Time Frame: 18months
18months
Direct cost of outpatient antipsychotic medication
Time Frame: 18months
18months
Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups
Time Frame: 18months
18months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prague Psychiatric Center

Investigators

  • Study Director: Filip Spaniel, MD, PhD, Prague Psychiatric Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 12, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITAREPS 2.0
  • NT/13292 - 3 (Registry Identifier: NT/13292 - 3)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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