Cognitive Impairments in Psychotic Disorders

Cognitive Impairment Clinical Trial

Official title:

The Timing of Cognitive Impairments in Psychotic Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597579
• Other study ID #: 2974-16-SMC
• Status: Recruiting
• Start date: February 12, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2022
• Source: Sheba Medical Center
• Contact: Noaz Cohen, MA
• Phone: 972-3-5303325
• Email: noaz.cohen[@]sheba.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Disease
• Mental Disorders
• Psychotic Disorders

Intervention

Diagnostic Test:
• DAPAR Tests (IQ equivalent test)
This study will compare DAPAR scores before and after the onset of the psychotic illness.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in DAPAR (An Israeli cognitive test) scores	Cognitive changes in both groups (lowest 10 - highest 90)	1 day (During recruitment visit)
Secondary	Psychotic Symptoms	PANSS-6 (Positive and Negative Syndrome Scale - Abbrevieted) scores (lowest 0- highest 36)	1 day (During recruitment visit)
Secondary	Social Functioning	PSP (Personal and Social Performance Scale) Scores (lowest 0- highest 100)	1 day (During recruitment visit)
Secondary	Cognitive Functioning	WAIS-III (Wechsler Adult Intelligence Scale) (4 specific sub-tests)	1 day (During recruitment visit)
Secondary	Coping strategies	COPE (Assessing Coping Strategies) scores (lowest 0 - highest 90)	1 day (During recruitment visit)