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

Sponsors and Collaborators:	Prague Psychiatric Center Eli Lilly and Company
Information provided by:	Prague Psychiatric Center
ClinicalTrials.gov Identifier:	NCT00712660

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

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Haloperidol Prochlorperazine Fluphenazine Amisulpride Haloperidol decanoate Haloperidol lactate Prochlorperazine maleate Chlorprothixene Trifluoperazine Risperidone Fluphenazine hydrochloride Prochlorperazine edisylate Fluphenazine enanthate Melperone Fluphenazine depot

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	ITAREPS Trial: A Prospective Randomized Double-Blind Controlled Study in IT-Aided Mobile Phone-Based Relapse Prevention Program in Schizophrenia.

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 ]

Estimated Enrollment:	150
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental In the active-ITAREPS group, the e-mail ALERT message feedback to the investigator will be activated. After detecting the early warning signs by ITAREPS, the Early Intervention Algorithm (EIA) will be applied in the active arm of the study.	Drug: antipsychotic dose increase 20% increase in the dose of current antipsychotic medication
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.	Other: no intervention Treatment as usual

Arms

Assigned Interventions

A: Experimental

In the active-ITAREPS group, the e-mail ALERT message feedback to the investigator will be activated. After detecting the early warning signs by ITAREPS, the Early Intervention Algorithm (EIA) will be applied in the active arm of the study.

Drug: antipsychotic dose increase

20% increase in the dose of current antipsychotic medication

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.

Other: no intervention

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, Ustavni
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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Spaniel F, Vohlídka P, Hrdlicka J, Kozený J, Novák T, Motlová L, Cermák J, Bednarík J, Novák D, Höschl C. ITAREPS: information technology aided relapse prevention programme in schizophrenia. Schizophr Res. 2008 Jan;98(1-3):312-7. Epub 2007 Oct 24.

Responsible Party:	Prague Psychiatric Center ( Filip Spaniel, M.D., PhD. )
Study ID Numbers:	ITA-04-2008
Study First Received:	June 6, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00712660 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by Prague Psychiatric Center:

prevention
relapse
schizophrenia

Study placed in the following topic categories:

Prochlorperazine
Neurotransmitter Agents
Sulpiride
Zotepine
Tiapride
Sultopride
Psychotropic Drugs
Olanzapine
Antiemetics
Metylperon
Haloperidol
Schizophrenia
Dopamine
Mental Disorders
Fluphenazine depot

Psychotic Disorders
Aripiprazole
Sertindole
Fluphenazine
Schizophrenia and Disorders with Psychotic Features
Chlorprothixene
Tranquilizing Agents
Risperidone
Central Nervous System Depressants
Trifluoperazine
Antipsychotic Agents
Serotonin
Quetiapine
Haloperidol decanoate
Clozapine

Additional relevant MeSH terms:

Prochlorperazine
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Haloperidol
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Fluphenazine depot
Fluphenazine
Schizophrenia and Disorders with Psychotic Features

Chlorprothixene
Tranquilizing Agents
Gastrointestinal Agents
Risperidone
Central Nervous System Depressants
Trifluoperazine
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Haloperidol decanoate
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009