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Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia

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: NCT00712660
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : April 2, 2013
Eli Lilly and Company
Information provided by (Responsible Party):
Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center

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 treated in the outpatient psychiatric setting, as evidenced by the reduction of the total number of hospitalizations due to relapse of psychosis at the end of the 12-months follow-up period in the active ITAREPS group compared to the control (treatment-as-usual) group.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: antipsychotic dose increase Other: no intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: A
In the active-ITAREPS group, the e-mail ALERT message feedback to the investigator will be activated. The core study intervention was 20% antipsychotic dose increase within 24 hours in response to a Pharmacological Intervention Requiring Event (PIRE) defined as either: A) the receipt of any INITIAL ALERT (IA) e-mail. A dose increase was obligatory in such cases regardless of the current clinical status of the patient; or B) the receipt of an ALERT EMERGENCY (AE) e-mail after which the investigator confirmed clinical worsening via phone contact with the patient. AE is defined as further worsening in EWSQ scores during 3 week period after announcement of IA.
Drug: antipsychotic dose increase
20% increase in the dose of current antipsychotic medication
Other Name: All antipsychotics approved for clinical use in Czech and Slovak Republic:

Placebo Comparator: TAU
In the treatment-as-usual study arm (control, non-active ITAREPS), the e-mail ALERT message feedback will not be activated. In this group, even in the presence of early warning sings, the investigators will be kept blinded to the EWSQ scores, will receive no ALERT message and thus no early pharmacologic intervention based on the ITAREPS program will be prompted. Treatment in the control group will consist of routine clinical and medication management with the frequency of visits common in the outpatient clinical settings. There will be no intevention based on ITAREPS.
Other: no intervention
Treatment as usual
Other Name: Treatment as usual

Primary Outcome Measures :
  1. The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder [ Time Frame: November 2008-November 2009 ]

Secondary Outcome Measures :
  1. EWSQ 10P and 10FM sensitivity, specificity, positive predictive value [ Time Frame: November 2008-November 2009 ]
  2. No. of hospitalization days [ Time Frame: November 2008-November 2009 ]
  3. Assessment of the natural course of the psychotic illness [ Time Frame: November 2008-November 2009 ]
  4. Correlation between baseline CGI and the No. of hospitalizations at the endpoint [ Time Frame: November 2008-November 2009 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  1. 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.
  2. A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
  3. 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).
  4. Clinical Global Impression scale - Severity (CGI-S) ≤ 3 at study Visit 1.
  5. All patients must be on stable doses of antipsychotic medication during the study entry.
  6. Absence of organic mental disorder, mental disorder due to psychoactive substance use or mental retardation.
  7. 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.
  8. Signed written informed consent. The informed consent process must be documented by signing the informed consent form prior to any study-related procedures.
  9. Eligibility for mobile phone communicating.

Exclusion Criteria:

  1. 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.
  2. 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): NCT00712660

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Czech Republic
Prague Psychiatric Center
Prague, Ustavni, Czech Republic, 181 03
Sponsors and Collaborators
Prague Psychiatric Center
Eli Lilly and Company
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Principal Investigator: Filip Spaniel, M.D., PhD., Prague Psychiatrc 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: NCT00712660    
Other Study ID Numbers: ITA-04-2008
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013
Keywords provided by Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs