SchizophreniaSCPPNCT02773108
Somatic Comorbidities in Psychiatric Patients
An observational study of Schizophrenia and Major Depression Disorder, run by Sveti Ivan Psychiatric Hospital at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Schizophrenia, Major Depression Disorder, Bipolar Affective Disorder
- How many people
- 1,061 participants
- Where
- 1 siteCroatia
- Study dates
- May 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psychiatric patients
Who may be able to join
- treatment in psychiatric hospital
Who cannot join
- acute suicidality
- dementia
- mental retardation
- acute psychosis
- intoxication
- inability to answer the questionnaire by themselves
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized | Hospitalized psychiatric patients | |
| Daily hospital | Not described | |
| Outpatients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of somatic comorbidities
Measured: 12 months
Secondary outcomes (1)
Clinical Global Impression- Improvement scale (CGI-I), Change from diagnosis
Measured: from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sveti Ivan Psychiatric Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ena Ivezic, Sveti Ivan Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773108
- Sponsor's protocol ID
- komorbiditeti
- Acronym
- SCPP
- Status last verified
- Jun 2019
- First submitted
- 12 May 2016
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31253196
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic Comorbidities in Psychiatric Patients
- ClinicalTrials.gov ID
- NCT02773108
- Acronym / sponsor ID
- SCPP / komorbiditeti
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,061 participants (actual)
- Lead sponsor
- Sveti Ivan Psychiatric HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hospitalized | – | –Hospitalized psychiatric patients |
| Daily hospital | – | – |
| Outpatients | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric patients
Key inclusion criteria (1 listed)
- treatment in psychiatric hospital
Key exclusion criteria (6 listed)
- acute suicidality
- dementia
- mental retardation
- acute psychosis
- intoxication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of somatic comorbidities
Time frame: 12 months
1 secondary outcome
Clinical Global Impression- Improvement scale (CGI-I), Change from diagnosis
Time frame: from baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Derived from this study: PubMed 31253196Jelec 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Major Depression Disorder, run by Sveti Ivan Psychiatric Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of somatic comorbidities (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02773108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.