Psychotic DisordersNCT05597579
Cognitive Impairments in Psychotic Disorders
An observational study of Psychotic Disorders and Cognitive Impairment, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders, Cognitive Impairment
- What is being tested?
- DAPAR Tests (IQ equivalent test)
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Feb 2020to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Mark Weiser, MD, +972-3-5303773
Mark Weiser, MD, Prof.
About this study
Official title: 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
Read the 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
- Psychotic Disorders, Cognitive Impairment
- Being tested
- DAPAR Tests (IQ equivalent test)
- Keywords
- Schizophrenia, Affective Disorders, IQ Tests, Psychotic Disorders, Cognition
- Medical subject headings
- Psychotic Disorders, Cognitive Dysfunction, Schizophrenia, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPAR Tests (IQ equivalent test)Diagnostic test
This study will compare DAPAR scores before and after the onset of the psychotic illness.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients diagnosed with psychotic disorder. Receives: Diagnostic Test: DAPAR Tests (IQ equivalent test) | |
| Control Group | Healthy Controls Receives: Diagnostic Test: DAPAR Tests (IQ equivalent test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in DAPAR (An Israeli cognitive test) scores
Cognitive changes in both groups (lowest 10 - highest 90)
Measured: 1 day (During recruitment visit)
Secondary outcomes (4)
Psychotic Symptoms
PANSS-6 (Positive and Negative Syndrome Scale - Abbrevieted) scores (lowest 0- highest 36)
Measured: 1 day (During recruitment visit)
Social Functioning
PSP (Personal and Social Performance Scale) Scores (lowest 0- highest 100)
Measured: 1 day (During recruitment visit)
Cognitive Functioning
WAIS-III (Wechsler Adult Intelligence Scale) (4 specific sub-tests)
Measured: 1 day (During recruitment visit)
Coping strategies
COPE (Assessing Coping Strategies) scores (lowest 0 - highest 90)
Measured: 1 day (During recruitment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start12 Feb 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mark Weiser, MD, Principal Investigator, Sheba Medical Center
- Investigators
- Mark Weiser, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597579
- Sponsor's protocol ID
- 2974-16-SMC
- Status last verified
- Oct 2022
- First submitted
- 24 Feb 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Timing of Cognitive Impairments in Psychotic Disorders
- ClinicalTrials.gov ID
- NCT05597579
- Acronym / sponsor ID
- 2974-16-SMC
- Conditions
- Psychotic Disorders, Cognitive Impairment
- Keywords
- Schizophrenia, Affective Disorders, IQ Tests, Psychotic Disorders, Cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: DAPAR Tests (IQ equivalent test)Patients diagnosed with psychotic disorder. |
| Control Group | – | Diagnostic Test: DAPAR Tests (IQ equivalent test)Healthy Controls |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAPAR Tests (IQ equivalent test)This study will compare DAPAR scores before and after the onset of the psychotic illness. | Diagnostic test | Control Group, Study Group |
Primary outcome
Changes in DAPAR (An Israeli cognitive test) scores
Time frame: 1 day (During recruitment visit)
Cognitive changes in both groups (lowest 10 - highest 90)
4 secondary outcomes
Psychotic Symptoms
Time frame: 1 day (During recruitment visit)
Social Functioning
Time frame: 1 day (During recruitment visit)
Cognitive Functioning
Time frame: 1 day (During recruitment visit)
Coping strategies
Time frame: 1 day (During recruitment visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Weiser, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders and Cognitive Impairment, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noaz Cohen, MA (972-3-5303325, noaz.cohen@sheba.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in DAPAR (An Israeli cognitive test) scores (time frame: 1 day (During recruitment visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.