## Protocol Section
### Identification Module
**NCT ID:** NCT05597579

**Brief Title:** Cognitive Impairments in Psychotic Disorders

**Official Title:** The Timing of Cognitive Impairments in Psychotic Disorders

#### Organization Study ID Info
**ID:** 2974-16-SMC
#### Organization
**Class:** OTHER_GOV
**Full Name:** Sheba Medical Center
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-28

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-02-12

**Type:** ACTUAL

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2022-10-28
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-24
**Study First Submit QC Date:** 2022-10-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Sheba Medical Center

#### Responsible Party

**Investigator Affiliation:** Sheba Medical Center

**Investigator Full Name:** Mark Weiser, MD, Principal Investigator

**Investigator Title:** Head of Psychiatry

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

**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.

### Conditions Module

**Conditions:**

- Psychotic Disorders

- Cognitive Impairment

**Keywords:**

- Schizophrenia

- Affective Disorders

- IQ Tests

- Psychotic Disorders

- Cognition

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients diagnosed with psychotic disorder.

**Intervention Names:**

- Diagnostic Test: DAPAR Tests (IQ equivalent test)

**Label:** Study Group

#### Arm Group 2

**Description:** Healthy Controls

**Intervention Names:**

- Diagnostic Test: DAPAR Tests (IQ equivalent test)

**Label:** Control Group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group

- Study Group

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

**Name:** DAPAR Tests (IQ equivalent test)

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Changes in DAPAR (An Israeli cognitive test) scores

**Time Frame:** 1 day (During recruitment visit)

#### Secondary Outcomes

**Description:** PANSS-6 (Positive and Negative Syndrome Scale - Abbrevieted) scores (lowest 0- highest 36)

**Measure:** Psychotic Symptoms

**Time Frame:** 1 day (During recruitment visit)

**Description:** PSP (Personal and Social Performance Scale) Scores (lowest 0- highest 100)

**Measure:** Social Functioning

**Time Frame:** 1 day (During recruitment visit)

**Description:** WAIS-III (Wechsler Adult Intelligence Scale) (4 specific sub-tests)

**Measure:** Cognitive Functioning

**Time Frame:** 1 day (During recruitment visit)

**Description:** COPE (Assessing Coping Strategies) scores (lowest 0 - highest 90)

**Measure:** Coping strategies

**Time Frame:** 1 day (During recruitment visit)

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** noaz.cohen@sheba.gov.il

**Name:** Noaz Cohen, MA

**Phone:** 972-3-5303325

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ramat-Gan

**Contacts:**

***Contact 1:***

- **Name:** Mark Weiser, MD

- **Phone:** +972-3-5303773

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mark Weiser, MD, Prof.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Israel

**Facility:** Sheba Medical Center

**Status:** RECRUITING

**Zip:** 52621

#### Overall Officials

**Official 1:**

**Affiliation:** Sheba Medical Center

**Name:** Mark Weiser, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003072

- Term: Cognition Disorders

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: HIGH

- As Found: Cognitive Impairment

- ID: M15376

- Name: Schizophrenia

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: HIGH

- As Found: Psychotic Disorders

- ID: M14473

- Name: Psychotic Disorders

- Relevance: HIGH

- As Found: Psychotic Disorders

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6301

- Name: Cognition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000060825

- Term: Cognitive Dysfunction

- ID: D000001523

- Term: Mental Disorders

- ID: D000011618

- Term: Psychotic Disorders

### Misc Info Module

- Version Holder: 2024-05-24
