SchizophreniaSCHIZOBATNCT02378818
Characterization of the Motivational Deficit in Schizophrenia and Depression
A study testing Force task, preference task, discount task, learning task. in people with Schizophrenia and Depression, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
This research focuses on disorders of motivation, responsible for a disability that patients experience daily. It is a disorder that affects behavior, especially social. Mechanisms, which result in these disorders, are poorly understood. This ignorance is responsible for the lack of effective therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Depression
- What is being tested?
- Force task, preference task, discount task, learning task.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2014to Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients :
- Age between 18 and 65 years
- Affiliation to a healthy insurance
- Subjects who were informed and willing to sign the form of free and informed consent and information of the curator if necessary (or consent of the tutor)
- French native tongue
- Diagnosis of schizophrenia according to ICD-10, made by a psychiatrist. The subjects are stabilized (less than three items include a score> = 4 or to the positive level (P) of the PANSS)
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- Unchanged psychotropic treatment for at least three months before inclusion, a minimal dose adjustment in the last month is tolerable.
- Healthy volunteers:
- Age between 18 and 65 years
- Affiliation to a healthy insurance
- Subjects who were informed and willing to sign the form of free and informed consent and information curator appropriate
- French native tongue
- Patients :
- Age between 18 and 75 years
- Affiliation to a healthy insurance
- Subjects informing and accepting to sign the free and lit consent form and information of the curator if necessary or consent of the tutor
- French Mother tongue
- Diagnosis of major depressive episode following the CIM-10, put by a psychiatrist.
- Healthy volunteers:
- age between 18 and 75 years
- Affiliation to a healthy insurance
- Subjects informing and accepting to sign the free and lit consent form
- French mother tongue
Who cannot join
- Patients:
- Unable major, persons deprived of liberty, pregnant women
- Enforced hospitalisation
- Recent abuse (1 week) or chronic use of addictive substances, except tobacco
- Treatment electro-convulsivo-therapy in the last 6 months
- Degenerative Pathology, neurological disorder
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- Co-occurrence of a major depressive episode in a schizophrenic patient evaluated by a score> 10 CDS
- Difficulty in understanding and expression in French language
- Deficit of visual acuity or uncorrected hearing
- Healthy volunteers:
- Unable major, persons deprived of liberty, pregnant women
- Current psychiatric disease
- Psychotropic treatment
- Recent abuse (1 week) or chronic use of addictive substances, except tobacco
- Difficulty in understanding and expression in French language
- Deficit of visual acuity or uncorrected hearing
- Mental retardation
- Patients
- persons deprived of liberty , pregnant women
- Admission under constraint
- Recent Abuse ( 1 week) or consumption chronicles of addicting substances, except the tobacco
- Treatment by electroconvulsivo-therapy
- Degenerative Pathology or obvious neurological disorder
- Diagnosis of schizophrenia or disorder of personality severe
- Difficulties of understanding and expression in French language
- Uncorrected visual or hearing Deficit of acuteness
- Healthy volunteers:
- Incapable, persons deprived of liberty, pregnant women
- Recent Abuse (1 week) or consumption chronicles of addicting substances, except tobacco
- Personal psychiatric Histories
- Current psychiatric Disorder
- Current psychotropic Treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sainte Anne
Paris, 75014
Raphaël GAILLARD, MD,PhD, + 33 1 45 65 81 54, r.gaillard@ch-sainte-anne.fr
Marie GODARD, + 33 1 45 65 77 28, m.godard@ch-sainte-anne.fr
About this study
Official title: SCHIZOBAT/DEPBAT : Characterization of the Motivational Deficit in Schizophrenia and Depression
This research focuses on disorders of motivation, responsible for a disability that patients experience daily. It is a disorder that affects behavior, especially social. Mechanisms, which result in these disorders, are poorly understood. This ignorance is responsible for the lack of effective therapy. The investigators realize this work in order to better understand the motivational deficits. The objective of the study is to characterize the cognitive mechanisms of motivational deficits in schizophrenia and depression. To answer the question posed in the research, it is planned to include 35 people with schizophrenia, 35 people with depression and 70 heathy volunteers in the Hospital of Sainte-Anne .
Read the detailed description
The investigator goal is to develop a neuropsychological battery to characterize the different aspects of motivation: energizing action, ability to use the clues to assign value, ability to anticipate a reward delayed in time, and finally learning by trial / error based rewards. In addition, the investigators systematically compare the effect of rewards and punishments (losses) in these spots. Such a systematic approach should better understand the nature of disrupted in schizophrenia process. It should also highlight the differential effects of treatment, including the effects of conventional antipsychotics versus atypical antipsychotics, but also the benefits of cognitive remediation.
In the depression:
The motivational deficit is at the heart of the depressive symptomatology. Our objective is to characterize the motivational processes altered in the depression thanks to the same neuropsychological battery. Furthermore, this clinical dimension could influence the answer to the antidepressant treatment. A better characterization of the motivational deficit would allow to adapt at best the pharmacological treatments used in the depression, in particular by targeting the dopaminergic way, involved in the control of the motivation.
The investigators will recruit 35 patients and 35 control subjects in both populations. The investigators will make them pass a battery of motivational tests described above on three half-days:
- Force task: This task tests the energization process, that is to say the ability to activate an action in proportion to what is involved.
It consists of two sessions of 60 trials, which are offset through six levels of monetary issue (1, 20, 50 cents, 1, 5, 20 euros), and lasts about 30 minutes. On each trial, patients must tighten the grip dynamometer in order to earn a reward proportional to both the level of monetary issue and the peak forces occurs, or avoid a financial loss of a magnitude equal. The award of this task will be made in subliminal conditions and in supraliminal, and in condition of mental effort with the use of a stroop test instead of the dynamometer.
- Preference task: This task tests the integrity of the "brain recovery system." It includes three subtests quotes 24 awards, 24 penalties and 24 efforts, and three subtests of binary choices with 48 trials each, and lasts about 30 minutes. Patients should note how various awards seem pleasant, how various punishments seem unpleasant, or how various efforts seem harsh. Registration vegetative markers (heart rate) compares the implied valuations for explicit assessments (notes), and thus to estimate the accuracy of introspection.
- Discount and effort task: These tasks are used to estimate the parameters of time counting efforts and punishments. In the task of counting time effort, patients must choose between making a small reward associated with a low time or earn a greater reward associated with a significant delay. In the task of temporal punishments count, patients must choose between experience low punishment in a short time, or suffer a greater punishment in a larger delay. These tasks can capture a form of apathy characterized by an exaggeration of fatigue or pain early.
- Learning task: It can test the overall learning abilities and specific sensitivities learning by positive and negative reinforcement. It consists of two sessions, each with 60 binary choices (24 associated with rewards, punishments associated with 24, 12 associated with neutral events), for a period of about 20 minutes. The second session will be provided in counterfactual condition.
- Conditions
- Schizophrenia, Depression
- Being tested
- Force task, preference task, discount task, learning task.
- Keywords
- Schizophrenia, Negative symptoms, Lack of motivation, Cognitive characterization, Computational psychiatry, Depression
- Medical subject headings
- Schizophrenia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Force task, preference task, discount task, learning task.Behavioural
Force task, preference task, discount task, learning task.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia patients | Other | 35 patients, Age between 18 and 65 years, with a diagnosis of schizophrenia and unchanged psychotropic treatment for at least three months before inclusion. Receives: Behavioral: Force task, preference task, discount task, learning task. |
| Healthy volunteers (schizophrenia) | Other | 35 healthy volunteers Receives: Behavioral: Force task, preference task, discount task, learning task. |
| Depressive patients | Other | Not described Receives: Behavioral: Force task, preference task, discount task, learning task. |
| Healthy volunteers (depression) | Other | Not described Receives: Behavioral: Force task, preference task, discount task, learning task. |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of force produced based in incentive reward
Measured: the first inclusion day
level of force produced based in incentive reward
Measured: up to third day
Secondary outcomes (3)
consistent level of choice questionnaire
Measured: the first inclusion day
The proportion of choosing the expensive option (great effort/big time/immediate effort)
Measured: the first inclusion day
The proportion of corrects choice
Measured: the first inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start21 Nov 2014
- Primary completionNov 2018 (estimated)
- Study completionJan 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 Centre Hospitalier St AnneThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Paris Brain Institute (ICM)
- Responsible party
- Sponsor
- Investigators
- Raphaël GAILLARD, MD, PhD, Principal investigator, Centre Hospitalier St Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378818
- Sponsor's protocol ID
- D14-P012
- Acronym
- SCHIZOBAT
- Status last verified
- Oct 2017
- First submitted
- 13 Aug 2014
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCHIZOBAT/DEPBAT : Characterization of the Motivational Deficit in Schizophrenia and Depression
- ClinicalTrials.gov ID
- NCT02378818
- Acronym / sponsor ID
- SCHIZOBAT / D14-P012
- Conditions
- Schizophrenia, Depression
- Keywords
- Schizophrenia, Negative symptoms, Lack of motivation, Cognitive characterization, Computational psychiatry, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Paris Brain Institute (ICM)
- Study start
- 21 Nov 2014 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- 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.
This research focuses on disorders of motivation, responsible for a disability that patients experience daily. It is a disorder that affects behavior, especially social. Mechanisms, which result in these disorders, are poorly understood. This ignorance is responsible for the lack of effective therapy. The investigators realize this work in order to better understand the motivational deficits. The objective of the study is to characterize the cognitive mechanisms of motivational deficits in schizophrenia and depression. To answer the question posed in the research, it is planned to include 35 people with schizophrenia, 35 people with depression and 70 heathy volunteers in the Hospital of Sainte-Anne .
Detailed description
The investigator goal is to develop a neuropsychological battery to characterize the different aspects of motivation: energizing action, ability to use the clues to assign value, ability to anticipate a reward delayed in time, and finally learning by trial / error based rewards. In addition, the investigators systematically compare the effect of rewards and punishments (losses) in these spots. Such a systematic approach should better understand the nature of disrupted in schizophrenia process. It should also highlight the differential effects of treatment, including the effects of conventional antipsychotics versus atypical antipsychotics, but also the benefits of cognitive remediation.
In the depression:
The motivational deficit is at the heart of the depressive symptomatology. Our objective is to characterize the motivational processes altered in the depression thanks to the same neuropsychological battery. Furthermore, this clinical dimension could influence the answer to the antidepressant treatment. A better characterization of the motivational deficit would allow to adapt at best the pharmacological treatments used in the depression, in particular by targeting the dopaminergic way, involved in the control of the motivation.
The investigators will recruit 35 patients and 35 control subjects in both populations. The investigators will make them pass a battery of motivational tests described above on three half-days:
- Force task: This task tests the energization process, that is to say the ability to activate an action in proportion to what is involved.
It consists of two sessions of 60 trials, which are offset through six levels of monetary issue (1, 20, 50 cents, 1, 5, 20 euros), and lasts about 30 minutes. On each trial, patients must tighten the grip dynamometer in order to earn a reward proportional to both the level of monetary issue and the peak forces occurs, or avoid a financial loss of a magnitude equal. The award of this task will be made in subliminal conditions and in supraliminal, and in condition of mental effort with the use of a stroop test instead of the dynamometer.
- Preference task: This task tests the integrity of the "brain recovery system." It includes three subtests quotes 24 awards, 24 penalties and 24 efforts, and three subtests of binary choices with 48 trials each, and lasts about 30 minutes. Patients should note how various awards seem pleasant, how various punishments seem unpleasant, or how various efforts seem harsh. Registration vegetative markers (heart rate) compares the implied valuations for explicit assessments (notes), and thus to estimate the accuracy of introspection.
- Discount and effort task: These tasks are used to estimate the parameters of time counting efforts and punishments. In the task of counting time effort, patients must choose between making a small reward associated with a low time or earn a greater reward associated with a significant delay. In the task of temporal punishments count, patients must choose between experience low punishment in a short time, or suffer a greater punishment in a larger delay. These tasks can capture a form of apathy characterized by an exaggeration of fatigue or pain early.
- Learning task: It can test the overall learning abilities and specific sensitivities learning by positive and negative reinforcement. It consists of two sessions, each with 60 binary choices (24 associated with rewards, punishments associated with 24, 12 associated with neutral events), for a period of about 20 minutes. The second session will be provided in counterfactual condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia patients | Other | Behavioral: Force task, preference task, discount task, learning task.35 patients, Age between 18 and 65 years, with a diagnosis of schizophrenia and unchanged psychotropic treatment for at least three months before inclusion. |
| Healthy volunteers (schizophrenia) | Other | Behavioral: Force task, preference task, discount task, learning task.35 healthy volunteers |
| Depressive patients | Other | Behavioral: Force task, preference task, discount task, learning task. |
| Healthy volunteers (depression) | Other | Behavioral: Force task, preference task, discount task, learning task. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients :
- Healthy volunteers:
- Patients :
- Healthy volunteers:
Key exclusion criteria (32 listed)
- Patients:
- Healthy volunteers:
- Patients
- Healthy volunteers:
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 |
|---|---|---|
| Force task, preference task, discount task, learning task.Force task, preference task, discount task, learning task. | Behavioural | Depressive patients, Healthy volunteers (depression), Healthy volunteers (schizophrenia), Schizophrenia patients |
Primary outcome
level of force produced based in incentive reward
Time frame: the first inclusion day
level of force produced based in incentive reward
Time frame: up to third day
3 secondary outcomes
consistent level of choice questionnaire
Time frame: the first inclusion day
The proportion of choosing the expensive option (great effort/big time/immediate effort)
Time frame: the first inclusion day
The proportion of corrects choice
Time frame: the first inclusion day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Raphaël GAILLARD, MD, PhD principal investigator
Centre Hospitalier St Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Force task, preference task, discount task, learning task. in people with Schizophrenia and Depression, run by Centre Hospitalier St Anne 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 23 inclusion and 32 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 25 Jan 2018. 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 Raphaël GAILLARD, MD, PhD (00 33 1 45 65 81 54, r.gaillard@ch-sainte-anne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of force produced based in incentive reward (time frame: the first inclusion day). The study lists 2 primary outcomes in all. 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 25 Jan 2018.