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Trial record 18 of 3335 for:    schizophrenia

A RCT Study in Schizophrenia Relapse Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01885923
Recruitment Status : Unknown
Verified July 2013 by Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center.
Recruitment status was:  Active, not recruiting
First Posted : June 25, 2013
Last Update Posted : July 12, 2013
Information provided by (Responsible Party):
Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center

Brief 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.

Condition or disease Intervention/treatment Phase
Relapse Schizophrenia Device: ITAREPS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective, Randomized, Open, Controlled Study With Information and Telecommunication Technology-aided Relapse Prevention Program in Schizophrenia.
Study Start Date : August 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.
Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia)
Other Name: 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.

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

Secondary Outcome Measures :
  1. Number of psychiatric hospitalization days [ Time Frame: 18months ]
  2. Direct impatient costs [ Time Frame: 18months ]
  3. Direct cost of outpatient antipsychotic medication [ Time Frame: 18months ]
  4. Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups [ Time Frame: 18months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01885923

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Czech Republic
Prague Psychiatric Center
Prague, Czech Republic, 18103
Sponsors and Collaborators
Prague Psychiatric Center
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Study Director: Filip Spaniel, MD, PhD Prague Psychiatric Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Filip Spaniel, M.D., Ph.D, MD, Prague Psychiatric Center Identifier: NCT01885923     History of Changes
Other Study ID Numbers: ITAREPS 2.0
NT/13292 - 3 ( Registry Identifier: NT/13292 - 3 )
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: July 2013
Keywords provided by Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center:
schizophrenia; relapse prevention; information technology
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes
Pathologic Processes