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

NCT00712660 | Completed

• 1 other identifier: ITA-04-2008
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

prevention; relapse; schizophrenia

Outcome Measures

Primary Outcomes (1)

• The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder

  November 2008-November 2009

Secondary Outcomes (4)

• EWSQ 10P and 10FM sensitivity, specificity, positive predictive value

  November 2008-November 2009

• No. of hospitalization days

  November 2008-November 2009

• Assessment of the natural course of the psychotic illness

  November 2008-November 2009

• Correlation between baseline CGI and the No. of hospitalizations at the endpoint

  November 2008-November 2009

Study Arms (2)

A

EXPERIMENTAL

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

TAU

PLACEBO COMPARATOR

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

Interventions

antipsychotic dose increase DRUG

20% increase in the dose of current antipsychotic medication

Also known as: All antipsychotics approved for clinical use in Czech and Slovak Republic:

A

no intervention OTHER

Treatment as usual

Also known as: Treatment as usual

TAU

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Hayward compliance rating scale score \< 2 at Visit 1.

Sponsors & Collaborators

• Prague Psychiatric Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Prague Psychiatric Center

Prague, Ustavni, 181 03, Czechia

Location

Related Publications (2)

• Spaniel F, Vohlidka P, Hrdlicka J, Kozeny J, Novak T, Motlova L, Cermak J, Bednarik J, Novak D, Hoschl C. ITAREPS: information technology aided relapse prevention programme in schizophrenia. Schizophr Res. 2008 Jan;98(1-3):312-7. doi: 10.1016/j.schres.2007.09.005. Epub 2007 Oct 24.

  PMID: 17920245 BACKGROUND

• Spaniel F, Hrdlicka J, Novak T, Kozeny J, Hoschl C, Mohr P, Motlova LB. Effectiveness of the information technology-aided program of relapse prevention in schizophrenia (ITAREPS): a randomized, controlled, double-blind study. J Psychiatr Pract. 2012 Jul;18(4):269-80. doi: 10.1097/01.pra.0000416017.45591.c1.

  PMID: 22805901 DERIVED

MeSH Terms

Conditions

Schizophrenia; Recurrence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Spaniel, M.D., PhD.,

  Prague Psychiatrc Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: July 10, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: March 1, 2012
• Last Updated: April 2, 2013

Record last verified: 2013-03

Locations

CZ (1)