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Completed

NCT Number: NCT01544608

Observe Real-life Allocation of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia

The primary objective of this Non- Interventional Study (NIS) is to describe the use of atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to acute psychotic episode by evaluation of drug, dose and mode of administration of the medication.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Cairo, Egypt

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About this study

RECONNECT-S BETA

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria.
  • Subject is hospitalised due to an acute psychotic episode.
  • Ability of the subject to understand and comply with the requirements of the study, as judged by the investigator.

Exclusion criteria

  • Current participation in any clinical trial.
  • Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period).

Treatment and study plan

Primary outcomes

  1. Use of atypical antipsychotic(s) during hospitalisation.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

  2. Daily dosage of atypical antipsychotic(s) during hospitalisation.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

  3. Mode of administration of atypical antipsychotic(s) during hospitalisation.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

Secondary outcomes

  1. Percent of patients with atypical antipsychotic as monotherapy.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

  2. Percent of patients with combinations of antipsychotics.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

  3. Main criteria of an antipsychotic's selection during hospitalisation expressed as percentage.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

  4. Use of psychometric scales in day to day practice in therm of evaluation of the disease symptoms and thus efficacy of the treatment.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

  5. Description of the usage of concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

  6. Relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge.

    Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).

    The data will be collected at one visit at the moment of discharge from the hospital.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Non- Interventional Study to Observe Real Life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia.

Acronym: RECONNECT-S

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 6, 2012
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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