NCT01544608

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,076

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

February 20, 2012

Last Update Submit

June 19, 2013

Conditions

Schizophrenia

Keywords

Acute psychotic episode of Schizophrenia

Outcome Measures

Primary Outcomes (3)

  • Use of atypical antipsychotic(s) during hospitalisation.

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

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

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

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

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

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

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

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

Secondary Outcomes (6)

  • Percent of patients with atypical antipsychotic as monotherapy.

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

  • Percent of patients with combinations of antipsychotics.

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

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

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

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

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

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

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

  • +1 more secondary outcomes

Study Arms (1)

Subjects who are hospitalized due to acute psychotic episode.

All subjects who are hospitalized due to acute psychotic episode. The subjects should be managed according to normal clinical practice until discharge time.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Psychiatric Institutes

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Cairo, Egypt

Location

Research Site

Dammam, Saudi Arabia

Location

Research Site

Jeddah, Saudi Arabia

Location

Research Site

Riyadh, Saudi Arabia

Location

Research Site

Abu Dhabi, United Arab Emirates

Location

Research Site

Dubai, United Arab Emirates

Location

Research Site

Ras al-Khaimah, United Arab Emirates

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Talaat Matar, CONSULTANT PSYCHIATRIST

    Obaid Alla Hospital,Ras Al Khaima,UAE

    STUDY CHAIR

  • Tarek Darwish, CONSULTANT PSYCHIATRIST

    Sheikh Khalifa Medical City(SKMC), Abudhabi,UAE

    STUDY CHAIR

  • Sohail Khan, CONSULTANT PSYCHIATRIST

    Jeddah Psychiatric hospital,Jeddah, Saudi Arabia

    STUDY CHAIR

  • Tarek Okasha, PROFESSOR

    Ain Shams University, Cairo, Egypt

    STUDY CHAIR

  • Mohamed Nasr, PROFESSOR

    Cairo University, Egypt

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2012

First Posted

March 6, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

EG(1)SA(3)AE(3)