Cognitive Impairments in Psychotic Disorders

The Timing of Cognitive Impairments in Psychotic Disorders

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

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders; Cognitive Impairment
• Intervention / Treatment: Diagnostic test: DAPAR Tests (IQ equivalent test)

Detailed Description

In this study the investigators aim to use the DAPAR tests (A cognitive assessment which all 17 year old Jewish adolescents in Israel undergo to participate in mandatory military service), which measures intelligence, and is equivalent to the IQ test. The subjects will be persons who had their first psychotic break, at least one year following the DAPAR tests. As part of the study, the participants will re-take the DAPAR tests, after the onset of the psychotic illness.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Noaz Cohen, MA; Phone Number: 972-3-5303325; Email: noaz.cohen@sheba.gov.il

Study Locations

• Israel
  • Ramat-Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
    • Contact: Mark Weiser, MD; Phone Number: +972-3-5303773
    • Principal Investigator: Mark Weiser, MD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria - Study Group:

• 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.

Inclusion Criteria - Control group:

• Participants between the ages of 27-18.
• No history of psychotic break.
• Previous DAPAR tests at the age of 17.

Exclusion Criteria - Both groups:

• Participants who did not perform the full battery of the DAPAR tests.
• Participants who have been appointed a guardian.

Exclusion Criteria - Control group:

- Participants who have a first-degree relative who suffers from a psychotic disorder.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Patients diagnosed with psychotic disorder.	Diagnostic test: DAPAR Tests (IQ equivalent test); This study will compare DAPAR scores before and after the onset of the psychotic illness.
Control Group; Healthy Controls	Diagnostic test: DAPAR Tests (IQ equivalent test); This study will compare DAPAR scores before and after the onset of the psychotic illness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in DAPAR (An Israeli cognitive test) scores	Cognitive changes in both groups (lowest 10 - highest 90)	1 day (During recruitment visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychotic Symptoms	PANSS-6 (Positive and Negative Syndrome Scale - Abbrevieted) scores (lowest 0- highest 36)	1 day (During recruitment visit)
Social Functioning	PSP (Personal and Social Performance Scale) Scores (lowest 0- highest 100)	1 day (During recruitment visit)
Cognitive Functioning	WAIS-III (Wechsler Adult Intelligence Scale) (4 specific sub-tests)	1 day (During recruitment visit)
Coping strategies	COPE (Assessing Coping Strategies) scores (lowest 0 - highest 90)	1 day (During recruitment visit)

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Mark Weiser, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognition; Psychotic Disorders; Affective Disorders; IQ Tests
• Additional Relevant MeSH Terms: Pathologic Processes; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Cognition Disorders; Disease; Psychotic Disorders; Mental Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2974-16-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No