Trial document





This trial has been registered retrospectively.
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  DRKS00005466

Trial Description

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Title

A European Non-Interventional Study (NIS) in Patients with Schizophrenia Treated with Antipsychotic Long-Acting Injections (LAIs)

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Trial Acronym

ALTO

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URL of the Trial

[---]*

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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.

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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.

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Organizational Data

  •   DRKS00005466
  •   2013/11/26
  •   [---]*
  •   no
  •   Approved
  •   5703/13, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F20 -  Schizophrenia
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Interventions/Observational Groups

  •   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.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   IV
  •   N/A
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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)

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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.

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Countries of Recruitment

  •   Germany
  •   Austria
  •   France
  •   United Kingdom
  •   Sweden
  •   Spain
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/07/05
  •   750
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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

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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

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Addresses

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    • H. Lundbeck A/S
    • Ms.  Valérie  Guérin 
    • 37-45 Quai du Président Roosevelt
    • 92445  Issy-les-Moulineaux
    • France
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    • Outcome Europe Sàrl
    • Ms.  Francesca  Cellauro 
    • Chemin du Glapin 6
    • 1162  St Prex
    • France
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    • Outcome Europe Sàrl
    • Ms.  Francesca  Cellauro 
    • Chemin du Glapin 6
    • 1162  St Prex
    • France
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Sources of Monetary or Material Support

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    • H. Lundbeck A/S
    • Ottiliavej 9
    • 2500  Valby
    • Denmark
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.