SchizophreniaNCT02853019
Emotion and Motivation in Patients With Psychosis
A study testing Electroencephalogram, Cognitive tasks and subjective evaluation scales in people with Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Anhedonia and avolition reflect emotional and motivational disorders, respectively. However, if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms remain poorly understood, and existing treatments are inefficient on these symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Electroencephalogram, Cognitive tasks and subjective evaluation scales
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2017to 1 Jun 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia
Who cannot join
- addiction problem
- invalidating visual sensory problems
- neurological history
- for the healthy volunteers: psychiatric history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Emotion and Motivation on Behaviour and Neural Activity in Patients With Psychosis
Anhedonia and avolition reflect emotional and motivational disorders, respectively. However, if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms remain poorly understood, and existing treatments are inefficient on these symptoms. The literature suggests that the impairment does not concern emotion or motivation per se, but rather their influence on cognition. This project aims at using recent advances in the fundamental domain to better understand the cognitive and neuronal mechanisms of the patients' alterations, and especially how emotion and motivation influence cognition in schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Electroencephalogram, Cognitive tasks, subjective evaluation scales
- Keywords
- Emotion, motivation, cognition, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalogramOther
electrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli
Cognitive tasksBehavioural
- clinical scales and subjective assessments of emotional and motivational stimuli
subjective evaluation scalesBehavioural
- clinical scales and subjective assessments of emotional and motivational stimuli
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Sham comparator | Healthy volunteers Receives: Other: Electroencephalogram; Behavioral: Cognitive tasks; Behavioral: subjective evaluation scales |
| Patients with schizophrenia | Experimental | Patients with schizophrenia Receives: Other: Electroencephalogram; Behavioral: Cognitive tasks; Behavioral: subjective evaluation scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen
Before each cognitive trial a primer will be displayed, which will be either neutral or convey emotion or motivation. The investigators will check whether this primer affects the subjects preparation by measuring the CNV, which is an evoked potential recorded with electroencephalography, and indexing preparatory effort.
Measured: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
Secondary outcomes (1)
Change in the amplitude of the LPP (Late Positive Potential) as a function of the primer displayed on the screen
The investigators will check whether primers affect the subjects attention by measuring the LPP, which is an evoked potential recorded with electroencephalography, and indexing sustained attention.
Measured: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start2 Feb 2017
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Why it stopped: not enough patients avalaible
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, Strasbourg, FranceThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853019
- Sponsor's protocol ID
- 6152
- Status last verified
- Aug 2024
- First submitted
- 23 May 2016
- Last updated
- 19 Aug 2025
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Emotion and Motivation on Behaviour and Neural Activity in Patients With Psychosis
- ClinicalTrials.gov ID
- NCT02853019
- Acronym / sponsor ID
- 6152
- Conditions
- Schizophrenia
- Keywords
- Emotion, motivation, cognition, schizophrenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients avalaible
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 2 Aug 2016 (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.
Anhedonia and avolition reflect emotional and motivational disorders, respectively. However, if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms remain poorly understood, and existing treatments are inefficient on these symptoms. The literature suggests that the impairment does not concern emotion or motivation per se, but rather their influence on cognition. This project aims at using recent advances in the fundamental domain to better understand the cognitive and neuronal mechanisms of the patients' alterations, and especially how emotion and motivation influence cognition in schizophrenia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Sham comparator | Other: Electroencephalogram, Behavioral: Cognitive tasks, Behavioral: subjective evaluation scalesHealthy volunteers |
| Patients with schizophrenia | Experimental | Other: Electroencephalogram, Behavioral: Cognitive tasks, Behavioral: subjective evaluation scalesPatients with schizophrenia |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia
Key exclusion criteria (4 listed)
- addiction problem
- invalidating visual sensory problems
- neurological history
- for the healthy volunteers: psychiatric history
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 |
|---|---|---|
| Electroencephalogramelectrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli | Other | Healthy volunteers, Patients with schizophrenia |
| Cognitive tasks- clinical scales and subjective assessments of emotional and motivational stimuli | Behavioural | Healthy volunteers, Patients with schizophrenia |
| subjective evaluation scales- clinical scales and subjective assessments of emotional and motivational stimuli | Behavioural | Healthy volunteers, Patients with schizophrenia |
Primary outcome
Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen
Time frame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
Before each cognitive trial a primer will be displayed, which will be either neutral or convey emotion or motivation. The investigators will check whether this primer affects the subjects preparation by measuring the CNV, which is an evoked potential recorded with electroencephalography, and indexing preparatory effort.
1 secondary outcome
Change in the amplitude of the LPP (Late Positive Potential) as a function of the primer displayed on the screen
Time frame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
Results and safety
The study was stopped early (reason given: not enough patients avalaible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram, Cognitive tasks and subjective evaluation scales in people with Schizophrenia, run by University Hospital, Strasbourg, France 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: not enough patients avalaible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen (time frame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)). 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 19 Aug 2025.