A European Non-Interventional Study (NIS) in Patients with Schizophrenia Treated with Antipsychotic Long-Acting Injections (LAIs)
Organizational Data
- DRKS-ID:
- DRKS00005466
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2013-11-26
- Last update in DRKS:
- 2018-09-19
- Registration type:
- Retrospective
Acronym/abbreviation of the study
ALTO
URL of the study
No Entry
Brief summary in lay language
The purpose of this study is to assess how Antipsychotic Long Acting Injections (LAIs) are used in practice by physicians, collect information to describe the characteristics of patients treated with LAIs and assess patient satisfaction with treatment and other outcomes.
Brief summary in scientific language
This non-interventional study is undertaken to understand the utilization of antipsychotic LAIs in inpatients/outpatients with schizophrenia in different European countries, and notably understand whether patients receiving typical or atypical LAIs differ; in addition the study aims to assess subjective well-being, benefits and burdens of currently available antipsychotic LAIs over long term, via the longitudinal follow-up of some of these patients (incident users of LAIs) over the course of 18 months, with recording of data at 5 time points, if the patient comes to routine practice visits and at time of treatment change (discontinuation, change of dose, addition of another antipsychotic) or study withdrawal.
Health condition or problem studied
- ICD10:
- F20 - Schizophrenia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Cross-sectional part: All patients (prevalent and incident users of LAIs ( (long acting injections)) complete four questionnaires at baseline visit: Birchwood Insight Scale, DAI-10 (drug attitude inventory), SWN-S (subjective well-being under neuroleptics) and TooL (tolerability and quality of life). Longitudinal part: All incident users of LAIs complete in addition the same four questionnaires at months 3, 6, 12 and 18.
Endpoints
- Primary outcome:
- Cross-sectional part: The primary objective is to characterize current real-life practice patterns for the use of LAIs by describing: − Provider and site characteristics of psychiatrists prescribing LAIs (once at start of study) − Socio-demographics and clinical characteristics of patients with schizophrenia receiving LAIs (at baseline visit). Longitudinal part: − To evaluate the subjective well-being in patients with schizophrenia, initiating a treatment with an antipsychotic LAI (months 3, 6, 12 and 18)
- Secondary outcome:
- Cross-sectional part (baseline visit): − To identify subgroups of patients (clusters of antipsychotic LAIs users) characterized by specific sets of attributes − To describe and compare psychiatrists' opinion on antipsychotic LAIs and their prescriptions to patients with schizophrenia. Longitudinal part (baseline vist and follow up visits months 3, 6, 12 and 18): − To examine the association between the severity of disease, insight, patient’s attitude to treatment and adherence to medication, side-effects, subjective well-being and functioning and how this relationship change over time − To describe the time to all cause discontinuation of antipsychotic LAIs and other patterns of use of antipsychotics LAIs (eg dose, polypharmacy etc), as well as reasons for discontinuations − To describe hospitalisation patterns and healthcare utilization and compare healthcare utilization in 12 months before the initiation of antipsychotic LAIs with healthcare utilization in 12 months after the initiation of antipsychotic LAIs.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- France
- Germany
- Spain
- Sweden
- United Kingdom
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Düsseldorf
- Doctor's practice Düsseldorf
- Doctor's practice Berlin
- Medical center LWL Kliniken Dortmund
- University medical center Klinik für Psychiatrie und Psychotherapie Regensburg
- University medical center Martin-Luther-Universität Halle Saale
- University medical center LVR Klinikum Duesseldorf
- Doctor's practice Oranienburg
- Doctor's practice Riesa
- Doctor's practice Plauen
- Doctor's practice Bad Saarow
- Doctor's practice Berlin
- University medical center Klinikum rechts der Isar München
- Medical center Bezirkskrankenhaus Augsburg
- Doctor's practice Westerstede
- Medical center Klinikum Chemitz gGmbH Chemitz
- Doctor's practice Hamburg
- Doctor's practice Schleswig
- Doctor's practice Gelsenkirchen
- Medical center ZNS-Zentrum für Nervenheilkunde Mannheim
- Doctor's practice Berlin
- Medical center Evangelisches Krankenhaus Bethanien Greifswald
- Medical center Marienhospital Dortmund
- Doctor's practice Berlin
- University medical center University Medical Center Mainz
- Medical center Zentralinstitut für Seelische Gesundheit Mannheim
- Doctor's practice Stralsund
- Medical center Klinik für Psychiatrie Jena
- University medical center Universitätsklinikum des Saarlandes Homburg / Saar
- University medical center Uniklinik Köln Köln
- Doctor's practice Schwäbisch-Gmünd
- Medical center Neuro-Centrum am Krankenhaus Grevenbroich
- Medical center Medizinische Studienzentrum Würzburg
- Doctor's practice Berlin
- Doctor's practice Hamburg
- Medical center MVZ Mittweida GbR Mittweida
- Doctor's practice Wetzlar
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-07-05
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 750
- Final Sample Size:
- 654
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- • The patient is an in- or out-patient • The patient is aged of 18 years or older • The patient has a diagnosis of schizophrenia according to ICD-10 criteria • The patient is receiving a typical or atypical antipsychotic LAI (Only patients initiating an antipsychotic LAI at study entry will be proposed to participate in the longitudinal part of the study) • The patient has signed the informed consent
Exclusion Criteria
• The patient is pregnant or breastfeeding • The patient has acute serious or unstable medical condition (other than schizophrenia) that would compromise patient study participation according to physician’s judgment • The patient attempted to commit suicide in the past 30 days • The patient is not able to read or consent • The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel • The patient has previously been enrolled in this study • The patient is currently participating to an interventional randomised clinical trial (or intend to participate during the course of this study) • The patient is, in the physician’s opinion, unlikely to comply with the protocol
Addresses
Primary Sponsor
- Address:
- H. Lundbeck A/SValérie Guérin37-45 Quai du Président Roosevelt92445 Issy-les-MoulineauxFrance
- Telephone:
- +33179412878
- Fax:
- +33141230095
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Outcome Europe SàrlFrancesca CellauroChemin du Glapin 61162 St PrexFrance
- Telephone:
- +39051363098
- Fax:
- +39051303698
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Outcome Europe SàrlFrancesca CellauroChemin du Glapin 61162 St PrexFrance
- Telephone:
- +39051363098
- Fax:
- +39051303698
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Outcome Europe SàrlFrancesca CellauroChemin du Glapin 61162 St PrexFrance
- Telephone:
- +39051363098
- Fax:
- +39051303698
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- H. Lundbeck A/SOttiliavej 92500 ValbyDenmark
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Fakultät für Medizin der Technischen Universität MünchenIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- +49-89-41404371
- Fax:
- +49-89-41404199
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-03-01
- Ethics committee number:
- 5703/13
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-06-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Sinal Study Report
- Summary of Clinical Study Report with signatures
- Summary of Clinical Stuidy Report in German Language
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry