SchizophreniaNCT00712660
Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia
A study testing antipsychotic dose increase in people with Schizophrenia, run by Prague Psychiatric Center at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- antipsychotic dose increase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteCzechia
- Study dates
- Nov 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
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.
Read the detailed description
Title of Study:
ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
Estimated Number of Study Centers and Countries:
30-40 outpatient psychiatrists in the Czech Republic and in the Slovak Republic.
Research Hypothesis:
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.
Study Phase:
Non Drug Interventional Study
Study Objective:
To evaluate effectiveness of the ITAREPS program in reduction of the number of hospitalizations due to relapse of psychosis. The ITAREPS program employs mobile phone communication between the psychiatrist and the patient. Subjects enrolled in the project (patient and his/her family member) are instructed to complete two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request sent automatically by the system. EWSQ detects proportional worsening (or a new onset) of psychotic symptoms compared to the last week's score of the completed questionnaire. Individual EWSQ scores are sent by the subjects back to the ITAREPS system as a SMS text message. If the EWSQ score exceeds given score thresholds, an immediate ALERT requesting a therapeutic intervention is announced to the investigator as an e-mail message and a timely pharmacological intervention is triggered in accordance with the Early Intervention Algorithm (EIA).
Study design:
This is an international, randomized, double-blind, controlled, design-blinded, non drug, interventional study. Subjects (patient and family member pairs) will be randomized at a 1:1 ratio into the interventional or control group. All subjects will complete the EWSQ on a weekly basis. In the interventional group, e-mail alert message feedback to the investigator will be active and the investigator will react by using the EIA. In the control (treatment-as-usual) group, alerts will not be generated and the investigator will detect and react on the potential signs of the psychotic relapse only by using the standard clinical approach. The ALERTs will be reported to the investigators in approximately 50% of all ALERT events but the investigators and subjects will be kept blinded about the real study design - parallel or (multiple) cross-over. The type of the study design is specified only in section 3.1.1. of the protocol. This section will not be available to the investigators and will be provided only for the purpose of the regulatory and ethics review.
Study duration: 12 months
Number of subjects:
150 enrolled patient/family member pairs (i.e. 300 subjects) resulting in expected 120 evaluable patient/family member pairs (i.e. 240 subjects) will be participating in the study.
Study population:
Male and female patients between 18 to 60 having ICD-10 diagnosis of schizophrenia or schizoaffective disorder and their healthy family members, both eligible for mobile phone communicating.
Statistical Methods:
The primary effectiveness analysis will be a comparison of the upper bound of 95% confidence interval (CI) for the mean number of hospitalizations in patients in the active ITAREPS group at month 12 compared to the control (treatment-as-usual) group. Rehospitalization risk will be analyzed using Kaplan-Meier survival analysis in both groups. An interim analysis evaluating the between group differences in the number of psychiatric hospitalization days will be performed after all enrolled patients have completed their Visit 2 (month 6).
- Conditions
- Schizophrenia
- Being tested
- antipsychotic dose increase, no intervention
- Keywords
- prevention, relapse, schizophrenia
- Medical subject headings
- Schizophrenia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antipsychotic dose increaseDrug
Also called All antipsychotics approved for clinical use in Czech and Slovak Republic:
20% increase in the dose of current antipsychotic medication
no interventionOther
Also called Treatment as usual
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder
Measured: November 2008-November 2009
Secondary outcomes (4)
EWSQ 10P and 10FM sensitivity, specificity, positive predictive value
Measured: November 2008-November 2009
No. of hospitalization days
Measured: November 2008-November 2009
Assessment of the natural course of the psychotic illness
Measured: November 2008-November 2009
Correlation between baseline CGI and the No. of hospitalizations at the endpoint
Measured: November 2008-November 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prague Psychiatric Center
- Sponsor type
- Other government
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center
- Investigators
- Filip Spaniel, M.D., PhD.,, Principal investigator, Prague Psychiatrc Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712660
- Sponsor's protocol ID
- ITA-04-2008
- Status last verified
- Mar 2013
- First submitted
- 6 Jun 2008
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17920245Spaniel 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.
PubMed 22805901
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
- ClinicalTrials.gov ID
- NCT00712660
- Acronym / sponsor ID
- ITA-04-2008
- Conditions
- Schizophrenia
- Keywords
- prevention, relapse, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Prague Psychiatric CenterOther government
- Collaborators
- Eli Lilly and Company
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title of Study:
ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
Estimated Number of Study Centers and Countries:
30-40 outpatient psychiatrists in the Czech Republic and in the Slovak Republic.
Research Hypothesis:
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.
Study Phase:
Non Drug Interventional Study
Study Objective:
To evaluate effectiveness of the ITAREPS program in reduction of the number of hospitalizations due to relapse of psychosis. The ITAREPS program employs mobile phone communication between the psychiatrist and the patient. Subjects enrolled in the project (patient and his/her family member) are instructed to complete two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request sent automatically by the system. EWSQ detects proportional worsening (or a new onset) of psychotic symptoms compared to the last week's score of the completed questionnaire. Individual EWSQ scores are sent by the subjects back to the ITAREPS system as a SMS text message. If the EWSQ score exceeds given score thresholds, an immediate ALERT requesting a therapeutic intervention is announced to the investigator as an e-mail message and a timely pharmacological intervention is triggered in accordance with the Early Intervention Algorithm (EIA).
Study design:
This is an international, randomized, double-blind, controlled, design-blinded, non drug, interventional study. Subjects (patient and family member pairs) will be randomized at a 1:1 ratio into the interventional or control group. All subjects will complete the EWSQ on a weekly basis. In the interventional group, e-mail alert message feedback to the investigator will be active and the investigator will react by using the EIA. In the control (treatment-as-usual) group, alerts will not be generated and the investigator will detect and react on the potential signs of the psychotic relapse only by using the standard clinical approach. The ALERTs will be reported to the investigators in approximately 50% of all ALERT events but the investigators and subjects will be kept blinded about the real study design - parallel or (multiple) cross-over. The type of the study design is specified only in section 3.1.1. of the protocol. This section will not be available to the investigators and will be provided only for the purpose of the regulatory and ethics review.
Study duration: 12 months
Number of subjects:
150 enrolled patient/family member pairs (i.e. 300 subjects) resulting in expected 120 evaluable patient/family member pairs (i.e. 240 subjects) will be participating in the study.
Study population:
Male and female patients between 18 to 60 having ICD-10 diagnosis of schizophrenia or schizoaffective disorder and their healthy family members, both eligible for mobile phone communicating.
Statistical Methods:
The primary effectiveness analysis will be a comparison of the upper bound of 95% confidence interval (CI) for the mean number of hospitalizations in patients in the active ITAREPS group at month 12 compared to the control (treatment-as-usual) group. Rehospitalization risk will be analyzed using Kaplan-Meier survival analysis in both groups. An interim analysis evaluating the between group differences in the number of psychiatric hospitalization days will be performed after all enrolled patients have completed their Visit 2 (month 6).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: antipsychotic dose increaseIn 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. |
| TAU | Placebo comparator | Other: no interventionIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antipsychotic dose increaseAlso: All antipsychotics approved for clinical use in Czech and Slovak Republic:20% increase in the dose of current antipsychotic medication | Drug | A |
| no interventionAlso: Treatment as usualTreatment as usual | Other | TAU |
Primary outcome
The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder
Time frame: November 2008-November 2009
4 secondary outcomes
EWSQ 10P and 10FM sensitivity, specificity, positive predictive value
Time frame: November 2008-November 2009
No. of hospitalization days
Time frame: November 2008-November 2009
Assessment of the natural course of the psychotic illness
Time frame: November 2008-November 2009
Correlation between baseline CGI and the No. of hospitalizations at the endpoint
Time frame: November 2008-November 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
- Background: PubMed 17920245Spaniel 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.
- Derived from this study: PubMed 22805901Spaniel 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.
Related trials for Schizophrenia
Not yet recruitingPhase 1
Phase I Trial of HHK101 in Patients With Schizophrenia
Schizophrenia
Not yet recruiting
Integrated Psychoeducation Program for Internalized Stigma in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Not yet recruiting
Non-Invasive Vagus Nerve Stimulation as a Probe to Map Functional Connectivity in Schizophrenia Using Functional Magnetic Resonance Imaging
Schizophrenia Spectrum Disorders
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
RecruitingPhase 3
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Spaniel, M.D., PhD., principal investigator
Prague Psychiatrc Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antipsychotic dose increase in people with Schizophrenia, run by Prague Psychiatric Center at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder (time frame: November 2008-November 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712660, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.