SchizophreniaSTROOPNCT03163706
Evaluation of Stroop Effect in Patients With Schizophrenia
A study testing Modified Stroop effect in people with Schizophrenia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The main objective of this study is to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Modified Stroop effect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2016to Jun 2019
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For both:
- MMSE score greater than or equal to, 22 if no grade ; 23 if study certificate or CAP or college without patent ; 25 if patent or school without the tray ; 26 or more when bin
- IQ ≥ 75 (fNART)
- Lextale score ≥ 28
- Age: between 18 and 45 years
- For patients :
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- DSM-5 criteria of schizophrenia
- Patients followed as outpatients,
- Age of onset of the disease less than 40 years,
- Patients whose disease has stabilized: no changes psychotropic treatment for at least 1 month
- Not more of a benzodiazepine,
- Patients on protection of justice or not,
- For controls :
- Matched for sex to patient
- Age-matched (+/- 3 years) to patient
- Matched for IQ (score fNART +/- 10% to patients
- Matched for Lextale score+/- 10% to patients
Who cannot join
- For patients :
- Any other comorbid psychiatric diagnosis of Axis I DSM-5
- Extrapyramidal syndrome or tardive dyskinesia (AIMS score <2 BARS score <2 and score Simpson and Angus <3)
- Calgary depression scale ≥ 6
- Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
- Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
Show all 21Show fewer
- Use of alcohol or cannabis before the age of 15 years
- Alcohol abuse in the past 6 months.
- Cannabis abuse in the past 6 months and cannabis use in the last 3 months.
- Patients with impaired vision or hearing preventing the realization of the tests.
- For controls:
- Any psychiatric diagnosis according to DSM-5, including addictions (excluding tobacco)
- Score HADS Anxiety ≥ 8 and Depression ≥ 8
- SCL90R: global severity score GSI> 0.33 for women and> 0.27 for men, or score diversity PST symptoms> 18.49 for men and> 21.97 for women or score of degree of discomfort PSDI> 1.27 for men and> 1.3 for women, scoring in the subscale Psychotic Features> 0.
- Presence of a personality disorder at PDQ4 +
- Head injuries, brain injuries or diseases,
- vision or hearing problems preventing the realization of the tests.
- Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
- Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
- Long-term Anticholinergic treatment.
- Related to the first degree diagnosed with a psychotic disorder
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Isabelle JALENQUES, 04 73 75 48 78, ijalenques@chu-clermontferrand.fr
About this study
The main objective of this study is to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).
Read the detailed description
First, participants will receive six categories of stimuli presented in a classical way: (1) incongruous stimulus classical (BLUE written in green for example); (2) associated incongruous stimuli (SKY written in green for example); (3) conventional congruent stimuli (BLUE written in blue for example); (4) associated congruent stimuli (SKY written in blue for example); (5) neutral words (BRIDGE written in green for example); And (6) neutral stimulus (XXXX written in green for example).
In a second step (after a 5 minute break), they will receive these six categories of stimuli, but only half will be presented in a classic way and the other half will be presented in order to attract attention as in Augustinova and Ferrand 2007). To do this, in (1) incongruous stimuli classical like BLUE, a single letter (like B for example) will be colored in green for example and the rest of the word (LUE) will appear in gray); In (2) incongruous stimuli associated as SKY, only K for example will be green and the rest of the word will appear in gray); In (3) conventional congruent stimuli such as BLUE, only B for example will be written in blue and the rest of the word will appear in gray); In (4) associated congruent stimuli such as SKY only K for example will be written in blue and the rest of the word will appear in gray); In (5) neutral words like BRIDGE, only D will be colored in green for example and the rest of the word will appear in gray; And finally, in (6) neutral stimuli like XXXX, only one X will be colored in green for example and the rest of the X will appear in gray.
The task will be to name the color of each word (by stating the color verbally) as quickly and correctly as possible, while ignoring the written word. In this experiment, we will measure the time taken to denominate the color (in milliseconds) as well as the percentages of incorrect answers.
The first step allows to determine the stroop effect and the second the semantic conflict.
- Conditions
- Schizophrenia
- Being tested
- Modified Stroop effect
- Keywords
- Schizophrenia, Stroop effect, Semantic conflict, Response conflict
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Stroop effectBehavioural
to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia patients | Experimental | Patients with DSM-5 criteria of schizophrenia Receives: Behavioral: Modified Stroop effect |
| Control group | Other | Control, no schizophrenia Receives: Behavioral: Modified Stroop effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semantic conflict in stroop test
The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. By comparing the stroop effect and the semantic conflict between patients and controls, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).
Measured: at day 1
Secondary outcomes (1)
Response conflict in stroop test
The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. Response conflict (time in milliseconds) is obtained by subtracting the semantic conflict (time in milliseconds obtained in the second step of the protocol) from the stroop effect (time in milliseconds obtained in the first step of the protocol).
Therefore, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start21 Sep 2016
- Primary completionOct 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Auvergne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163706
- Sponsor's protocol ID
- CHU-330
- Other IDs
- 2014-A00957-40
- Acronym
- STROOP
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stroop Effect in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03163706
- Acronym / sponsor ID
- STROOP / CHU-330
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Stroop effect, Semantic conflict, Response conflict
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Université d'Auvergne
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 23 May 2017 (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.
The main objective of this study is to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).
Detailed description
First, participants will receive six categories of stimuli presented in a classical way: (1) incongruous stimulus classical (BLUE written in green for example); (2) associated incongruous stimuli (SKY written in green for example); (3) conventional congruent stimuli (BLUE written in blue for example); (4) associated congruent stimuli (SKY written in blue for example); (5) neutral words (BRIDGE written in green for example); And (6) neutral stimulus (XXXX written in green for example).
In a second step (after a 5 minute break), they will receive these six categories of stimuli, but only half will be presented in a classic way and the other half will be presented in order to attract attention as in Augustinova and Ferrand 2007). To do this, in (1) incongruous stimuli classical like BLUE, a single letter (like B for example) will be colored in green for example and the rest of the word (LUE) will appear in gray); In (2) incongruous stimuli associated as SKY, only K for example will be green and the rest of the word will appear in gray); In (3) conventional congruent stimuli such as BLUE, only B for example will be written in blue and the rest of the word will appear in gray); In (4) associated congruent stimuli such as SKY only K for example will be written in blue and the rest of the word will appear in gray); In (5) neutral words like BRIDGE, only D will be colored in green for example and the rest of the word will appear in gray; And finally, in (6) neutral stimuli like XXXX, only one X will be colored in green for example and the rest of the X will appear in gray.
The task will be to name the color of each word (by stating the color verbally) as quickly and correctly as possible, while ignoring the written word. In this experiment, we will measure the time taken to denominate the color (in milliseconds) as well as the percentages of incorrect answers.
The first step allows to determine the stroop effect and the second the semantic conflict.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia patients | Experimental | Behavioral: Modified Stroop effectPatients with DSM-5 criteria of schizophrenia |
| Control group | Other | Behavioral: Modified Stroop effectControl, no schizophrenia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- MMSE score greater than or equal to, 22 if no grade ; 23 if study certificate or CAP or college without patent ; 25 if patent or school without the tray ; 26 or more when bin
- IQ ≥ 75 (fNART)
- Lextale score ≥ 28
- Age: between 18 and 45 years
- DSM-5 criteria of schizophrenia
Key exclusion criteria (21 listed)
- Any other comorbid psychiatric diagnosis of Axis I DSM-5
- Extrapyramidal syndrome or tardive dyskinesia (AIMS score <2 BARS score <2 and score Simpson and Angus <3)
- Calgary depression scale ≥ 6
- Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
- Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
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 |
|---|---|---|
| Modified Stroop effectto assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict). | Behavioural | Control group, Schizophrenia patients |
Primary outcome
Semantic conflict in stroop test
Time frame: at day 1
The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. By comparing the stroop effect and the semantic conflict between patients and controls, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).
1 secondary outcome
Response conflict in stroop test
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Stroop effect in people with Schizophrenia, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 17 inclusion and 21 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 23 May 2017. 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 France. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semantic conflict in stroop test (time frame: at day 1). 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 23 May 2017.