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Active, not recruitingNCT05843357PAPSYUpdated Jul 16, 2025

PAPSY - Memory in Psychiatry

An observational study in Cognitive Impairment, sponsored by Charles University, Czech Republic. Active, not recruiting at 1 site in Czechia. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by Charles University, Czech Republic · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
1,000
Ages
45 Years and older
Sex
All
01

Study summary

Memory in Psychiatry project (PAPSY) aims to map the distribution and severity of cognitive impairment in patients of outpatient psychiatric offices across the geographical area of the Czech Republic. 1000 patients in 90 psychiatric offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (sFAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms. If applicable, caretakers will also be asked about the extent of the participant's autonomy and behavioral impairment (using oFAQ-CZ and MBI-C-CZ scales).

The trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in psychiatric care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated.

02

Conditions studied

  • Cognitive Impairment

Keywords

  • Cognitive Impairment
  • Outpatient Psychiatric Service
  • Population Distribution
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The population is intended to be comprised of persons (45yrs+) living in the geographical area of the Czech Republic undergoing a treatment at an outpatient psychiatric office for a diagnosis defined in ICD-10 (excluding mental retardation). The probability sample will be created by a random selection of persons undergoing their regular outpatient psychiatric checkups.

Inclusion criteria

  • Dispensarization of at least six months in an outpatient psychiatric office with an ICD-10 diagnosis
  • Age>=45
  • Permanent residency in the geographical area of the Czech Republic

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of mental retardation (F70-F79) according to ICD-10
  • Refusal to sign the informed consent and consent with GDPR
  • Uncorrected visual impairment
  • Uncorrected auditory impairment
  • Inability to participate in the project
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observed group

    No intervention will be administered on behalf of the project. The participants will be tested using ALBA and PICNIR (non-invasive) cognitive tests, and further sFAQ-CZ and GDS-CZ questionnaires will be administered. Questionnaires FAQ-CZ and MBI-C-CZ will be distributed to participants´ caretakers.

06

What researchers measure

Primary outcomes

  1. Baseline ALBA

    Amnesia Light and Brief Assessment (ALBA) test is an innovative method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-12 (a lower value denotes a more severe cognitive impairment).

    Time frame: Established on Day 0 as a single assessment.

  2. Baseline PICNIR

    Picture Naming and Immediate Recall test (PICNIR) is an innovative test method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-20 (a lower value denotes a more severe cognitive impairment).

    Time frame: Established on Day 0 as a single assessment.

  3. Statistical analysis of ALBA results,

    Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data.

    Time frame: The final statistical analysis will be performed through study completion, an average of 6 months.

  4. Statistical analysis of PICNIR results.

    Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data.

    Time frame: The final statistical analysis will be performed through study completion, an average of 6 months.

Secondary outcomes

  1. Baseline MBI-C-CZ

    Mild Behavioral Impairment - Checklist - Czech version (MBI-C-CZ) is a standardized questionnaire to assess behavioral impairment in 34 items. Each item is scaled between 0-3 (a higher value denotes a higher severity) to reach the overall score between 0-102 (a higher value denotes a higher overall severity of behavioral impairments)

    Time frame: Established as a baseline on Day 0.

  2. Baseline sFAQ-CZ

    Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for participants´ self-evaluation.

    Time frame: Established as a baseline on Day 0.

  3. Baseline GDS-CZ

    The Geriatric Depression Scale - Czech version (GDS-CZ) is a standardized questionnaire administered to assess depressive symptoms, particularly in the elderly population. Fifteen items are scaled between 0-1 to reach the overall score between 0-15 (a higher value denotes a higher level of depressive symptoms).

    Time frame: Established as a baseline on Day 0.

  4. Baseline oFAQ-CZ

    Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for caretakers´ evaluation of participants´ functioning.

    Time frame: Established as a baseline on Day 0.

07

Study locations

1 site
  • Teaching Hospital Královské Vinohrady
    Prague, Prague 10000, Czechia
08

References and documents

Individual participant data

Plan to share: Yes — IPD is to be shared upon request by a verified researcher. The study director´s discretion is reserved.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05843357
Lead sponsor
Charles University, Czech Republic
Responsible party
Tadeáš Mareš (Consultation-liaison psychiatrist, Charles University, Czech Republic) — Principal investigator
First posted
May 6, 2023
Start date
Mar 8, 2023
Primary completion
Dec 1, 2023
Completion
Dec 2025 (estimated)
Last update
Jul 16, 2025

Study contacts

Aleš Bartoš, M.D., Ph.D.
principal investigator · Charles University, Czech Republic
Tadeáš Mareš, M.D.
principal investigator · Charles University, Czech Republic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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