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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center
ClinicalTrials.gov Identifier:
NCT00712660
First received: June 6, 2008
Last updated: March 31, 2013
Last verified: March 2013
  Purpose

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 Intervention
Schizophrenia
Drug: antipsychotic dose increase
Other: no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Prague Psychiatric Center:

Primary Outcome Measures:
  • The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder [ Time Frame: November 2008-November 2009 ] [ Designated as safety issue: No ]

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

Enrollment: 146
Study Start Date: November 2008
Study Completion Date: March 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712660

Locations
Czech Republic
Prague Psychiatric Center
Prague, Ustavni, Czech Republic, 181 03
Sponsors and Collaborators
Prague Psychiatric Center
Eli Lilly and Company
Investigators
Principal Investigator: Filip Spaniel, M.D., PhD., Prague Psychiatrc Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Filip Spaniel, M.D., Ph.D, MD, Prague Psychiatric Center
ClinicalTrials.gov Identifier: NCT00712660     History of Changes
Other Study ID Numbers: ITA-04-2008
Study First Received: June 6, 2008
Last Updated: March 31, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Prague Psychiatric Center:
prevention
relapse
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014