NCT02773108

Brief Summary

Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic comorbidities in psychiatric patients population and the general Croatian population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,061

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

May 12, 2016

Last Update Submit

June 23, 2019

Conditions

SchizophreniaMajor Depression DisorderBipolar Affective Disorder

Outcome Measures

Primary Outcomes (1)

  • Prevalence of somatic comorbidities

    12 months

Secondary Outcomes (1)

  • Clinical Global Impression- Improvement scale (CGI-I), Change from diagnosis

    from baseline to 12 months

Study Arms (3)

Hospitalized

Hospitalized psychiatric patients

Daily hospital

Outpatients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Psychiatric patients

You may qualify if:

  • treatment in psychiatric hospital

You may not qualify if:

  • acute suicidality
  • dementia
  • mental retardation
  • acute psychosis
  • intoxication
  • inability to answer the questionnaire by themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PB Sveti Ivan

Zagreb, 10000, Croatia

Location

Related Publications (1)

  • Jelec V, Bajic Z, Simunovic Filipcic I, Portolan Pajic I, Sentija Knezevic M, Miloloza I, Radic-Kristo D, Benjak T, Jaksic N, Sagud M, Wang W, Filipcic I. Utilization of somatic healthcare in Croatian patients with schizophrenia spectrum disorder, major depression, PTSD and the general population. BMC Psychiatry. 2019 Jun 28;19(1):203. doi: 10.1186/s12888-019-2190-8.

    PMID: 31253196DERIVED

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MA

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 16, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2016

Study Completion

December 1, 2018

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)