NCT05597579

Brief Summary

Patients with Psychotic disorders (Schizophrenia, Bipolar disorder and Schizoaffective disorder) often suffer from significant cognitive impairments, however how these develop and change over time before and after the first psychotic break is unclear. While there are data by several groups, showing that many future patients have significant cognitive impairments years before the onset of psychosis, many future patients seem to be doing well before the manifestation of psychosis, and decline steeply in functioning after their first psychotic episode. Hence the timing of the onset of cognitive impairment in patients with psychotic disorders requires further exploration. The current study will investigate the timing of cognitive impairment by using IQ tests before and after the first psychotic break

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 12, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

3.2 years

First QC Date

February 24, 2022

Last Update Submit

October 27, 2022

Conditions

Psychotic DisordersCognitive Impairment

Keywords

SchizophreniaAffective DisordersIQ TestsPsychotic DisordersCognition

Outcome Measures

Primary Outcomes (1)

  • Changes in DAPAR (An Israeli cognitive test) scores

    Cognitive changes in both groups (lowest 10 - highest 90)

    1 day (During recruitment visit)

Secondary Outcomes (4)

  • Psychotic Symptoms

    1 day (During recruitment visit)

  • Social Functioning

    1 day (During recruitment visit)

  • Cognitive Functioning

    1 day (During recruitment visit)

  • Coping strategies

    1 day (During recruitment visit)

Study Arms (2)

Study Group

Patients diagnosed with psychotic disorder.

Diagnostic Test: DAPAR Tests (IQ equivalent test)

Control Group

Healthy Controls

Diagnostic Test: DAPAR Tests (IQ equivalent test)

Interventions

DAPAR Tests (IQ equivalent test)DIAGNOSTIC_TEST

This study will compare DAPAR scores before and after the onset of the psychotic illness.

Control GroupStudy Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The investigators will recruit patients treated in the psychiatric unit at the Sheba Medical Center and in other medical institutions throughout the country. Additionally, subjects will be recruited through internet advertisement of the study. All subjects will give informed consent. Control group will be recruited by matching for Age, Sex and socioeconomic status. recruitment will be preforemd by advertisement.

You may qualify if:

  • Patients between the ages 27-18 who had first psychotic break in the last ten years, and more than a year from the date of the DAPAR tests.
  • Diagnoses of schizophrenia, Bipolar disorder or Schizoaffective disorder according to DSM-5 criteria.
  • Previous DAPAR tests at the age of 17.
  • Participants between the ages of 27-18.
  • No history of psychotic break.
  • Previous DAPAR tests at the age of 17.

You may not qualify if:

  • Participants who did not perform the full battery of the DAPAR tests.
  • Participants who have been appointed a guardian.
  • \- Participants who have a first-degree relative who suffers from a psychotic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Psychotic DisordersCognitive DysfunctionSchizophreniaMood Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Mark Weiser, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noaz Cohen, MA

CONTACT

972-3-5303325noaz.cohen@sheba.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Psychiatry

Study Record Dates

First Submitted

February 24, 2022

First Posted

October 28, 2022

Study Start

February 12, 2020

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)