Somatic Comorbidities in Psychiatric Patients | NCT02773108

Studies
Somatic Comorbidities in Psychiatric Patients

NCT02773108

Sponsor

Sveti Ivan Psychiatric Hospital

Status

Completed

Last Update Posted

Jun 25, 2019Actual

Enrollment

1,061Actual

Phase

Not provided

Conditions

Schizophrenia
Major Depression Disorder
Bipolar Affective Disorder

Interventions

Not provided

Countries

Croatia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Dec 2018Actual

First Submitted Date

May 12, 2016

First Submission Date that Met QC Criteria

May 13, 2016

First Posted Date

May 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2019

Last Update Posted Date

Jun 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,061Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hospitalized		Hospitalized psychiatric patients
Daily hospital
Outpatients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of somatic comorbidities		12 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical Global Impression- Improvement scale (CGI-I), Change from diagnosis		from baseline to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

treatment in psychiatric hospital

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Psychiatric patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PB Sveti Ivan		Zagreb		10000	Croatia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31253196	Derived	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.

ID	Term
D012559	Schizophrenia
D001714	Bipolar Disorder

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders