Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia
This study has been completed.
Sponsor:
Prague Psychiatric Center
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
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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:
- 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.
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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 Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013