Relapse SchizophreniaNCT01885923
A RCT Study in Schizophrenia Relapse Prevention
A study testing ITAREPS in people with Relapse Schizophrenia, run by Prague Psychiatric Center at 1 site in Czechia.
Trial summary
THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapse Schizophrenia
- What is being tested?
- ITAREPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- Aug 2012to Dec 2015
- 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
- For entry into the study, the following criteria MUST be met:
- Men and women, ages 18 to 60 years, inclusive.
- A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
- Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.
- Severity (CGI-S) ≤ 3 at study Visit 1.
- All patients must be on stable doses of antipsychotic medication during the study entry.
Who cannot join
- Organic mental disorder,
- mental disorder due to psychoactive substance use or mental retardation.
- Participation in another relapse prevention program.
- Hayward compliance rating scale score < 2 at Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Open, Controlled Study With Information and Telecommunication Technology-aided Relapse Prevention Program in Schizophrenia.
THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in ITAREPS will demonstrate statistically significantly reduced risk of hospitalization, decreased number of hospitalization days and reduced direct inpatient costs in comparison to control group not using the program.
Read the detailed description
The ITAREPS 2.0 program employs telecommunication and information technologies in order to detect fluctuations in longitudinal mental health status of patient with schizophrenia and thus signalize the very early stages of prodromes preceding relapse. This approach opens an avenue towards early pharmacological intervention. Subjects (150 patients with diagnosis of schizophrenia and schizoaffective disorder and their family members) will be randomized at a 1:1 ratio into the active or control group. Participants from the active group will be completing two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request generated automatically by the system during 18 months study duration. In this group, automatically generated e-mail alert message feedback to the investigator will be activated in case of prodrome detection, prompting investigator to antipsychotic dose increase by 20%. The control (treatment-as-usual) group will not use ITAREPS system.
- Conditions
- Relapse Schizophrenia
- Being tested
- ITAREPS
- Keywords
- schizophrenia; relapse prevention; information technology
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITAREPSDevice
Also called Information Technology Aided Relaps Prevention in Schizophrenia
Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia)
| Study group | Role | What they receive |
|---|---|---|
| 20% antisychotic dose increase in prodromes | Active comparator | Antipsychotic dose increase upon prodromes occurence detected by Device- ITAREPS system. All antipsychotics currently registered in Czech Republic will be allowed in this study. All patients will remain on antipsychotic treatment adjusted prior enrollment, so that dose adjustment will be based on their ordinary medication. Participants will be instructed to complete the 10-item EWS Questionnaire upon SMS request sent automatically weekly to their mobile phones. EWSQ detects proportional worsening of the symptoms compared to the last week's score of the questionnaire. Individual EWSQ scores will be sent by participants back to the ITAREPS system as a SMS. If the total score exceeds the given score threshold, an immediate ALERT would be declared and announced to the investigator as an e-mail message and a therapeutic intervention is requested. After detecting the early warning signs by ITAREPS, an immediate 20% increase in the dose of antipsychotic will be required. Receives: Device: ITAREPS |
| Treatment as usual | No intervention | In the control group (treatment-as-usual) participants will not be enrolled in the ITAREPS system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.
Measured: 18 months
Secondary outcomes (4)
Number of psychiatric hospitalization days
Measured: 18months
Direct impatient costs
Measured: 18months
Direct cost of outpatient antipsychotic medication
Measured: 18months
Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups
Measured: 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapse 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prague Psychiatric Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center
- Investigators
- Filip Spaniel, MD, PhD, Study director, Prague Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885923
- Sponsor's protocol ID
- ITAREPS 2.0
- Other IDs
- NT/13292 - 3
- Status last verified
- Jul 2013
- First submitted
- 14 Aug 2012
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Spaniel F, Novak T, Bankovska Motlova L, Capkova J, Slovakova A, Trancik P, Matejka M, Hoschl C. Psychiatrist's adherence: a new factor in relapse prevention of schizophrenia. A randomized controlled study on relapse control through telemedicine system. J Psychiatr Ment Health Nurs. 2015 Dec;22(10):811-20. doi: 10.1111/jpm.12251. Epub 2015 Jul 14.
PubMed 26176646
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open, Controlled Study With Information and Telecommunication Technology-aided Relapse Prevention Program in Schizophrenia.
- ClinicalTrials.gov ID
- NCT01885923
- Acronym / sponsor ID
- ITAREPS 2.0
- Conditions
- Relapse Schizophrenia
- Keywords
- schizophrenia; relapse prevention; information technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Prague Psychiatric CenterOther government
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Jun 2013 (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.
THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in ITAREPS will demonstrate statistically significantly reduced risk of hospitalization, decreased number of hospitalization days and reduced direct inpatient costs in comparison to control group not using the program.
Detailed description
The ITAREPS 2.0 program employs telecommunication and information technologies in order to detect fluctuations in longitudinal mental health status of patient with schizophrenia and thus signalize the very early stages of prodromes preceding relapse. This approach opens an avenue towards early pharmacological intervention. Subjects (150 patients with diagnosis of schizophrenia and schizoaffective disorder and their family members) will be randomized at a 1:1 ratio into the active or control group. Participants from the active group will be completing two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request generated automatically by the system during 18 months study duration. In this group, automatically generated e-mail alert message feedback to the investigator will be activated in case of prodrome detection, prompting investigator to antipsychotic dose increase by 20%. The control (treatment-as-usual) group will not use ITAREPS system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% antisychotic dose increase in prodromes | Active comparator | Device: ITAREPSAntipsychotic dose increase upon prodromes occurence detected by Device- ITAREPS system. All antipsychotics currently registered in Czech Republic will be allowed in this study. All patients will remain on antipsychotic treatment adjusted prior enrollment, so that dose adjustment will be based on their ordinary medication. Participants will be instructed to complete the 10-item EWS Questionnaire upon SMS request sent automatically weekly to their mobile phones. EWSQ detects proportional worsening of the symptoms compared to the last week's score of the questionnaire. Individual EWSQ scores will be sent by participants back to the ITAREPS system as a SMS. If the total score exceeds the given score threshold, an immediate ALERT would be declared and announced to the investigator as an e-mail message and a therapeutic intervention is requested. After detecting the early warning signs by ITAREPS, an immediate 20% increase in the dose of antipsychotic will be required. |
| Treatment as usual | No intervention | –In the control group (treatment-as-usual) participants will not be enrolled in the ITAREPS system. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women, ages 18 to 60 years, inclusive.
- A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
- Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.
- 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 (4 listed)
- Organic mental disorder,
- mental disorder due to psychoactive substance use or mental retardation.
- Participation in another relapse prevention program.
- 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 |
|---|---|---|
| ITAREPSAlso: Information Technology Aided Relaps Prevention in SchizophreniaProgram ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia) | Device | 20% antisychotic dose increase in prodromes |
Primary outcome
Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.
Time frame: 18 months
4 secondary outcomes
Number of psychiatric hospitalization days
Time frame: 18months
Direct impatient costs
Time frame: 18months
Direct cost of outpatient antipsychotic medication
Time frame: 18months
Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups
Time frame: 18months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
- Derived from this study: PubMed 26176646Spaniel F, Novak T, Bankovska Motlova L, Capkova J, Slovakova A, Trancik P, Matejka M, Hoschl C. Psychiatrist's adherence: a new factor in relapse prevention of schizophrenia. A randomized controlled study on relapse control through telemedicine system. J Psychiatr Ment Health Nurs. 2015 Dec;22(10):811-20. doi: 10.1111/jpm.12251. Epub 2015 Jul 14.
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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, MD, PhD study director
Prague Psychiatric 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 ITAREPS in people with Relapse 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Jul 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. 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?
Results are not available in the source record.
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?
Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group. (time frame: 18 months). 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 NCT01885923, which also lists 1 linked publication.
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 12 Jul 2013.