Cognitive Impairments in Psychotic Disorders

Sponsor

Sheba Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05597579

Collaborator

(none)

200

Enrollment

Location

50.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders Cognitive Impairment	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

The Timing of Cognitive Impairments in Psychotic Disorders

Actual Study Start Date :

Feb 12, 2020

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Changes in DAPAR (An Israeli cognitive test) scores [1 day (During recruitment visit)]
Cognitive changes in both groups (lowest 10 - highest 90)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.