Bipolar Affective DisorderNCT03249857
Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
A study testing cognitive tasks + IQ + MINI and cognitive tasks in people with Bipolar Affective Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Based in an embodied approach of cognition, several studies have highlighted a direct link between perception of an object or an emotion and the associated motor responses. This study investigated in patients suffering from bipolar affective disorders whether the perception of emotional words involves an automatic… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Affective Disorder
- What is being tested?
- cognitive tasks + IQ + MINI and cognitive tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2017to 21 Aug 2018
- 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
- For patients:
- Affiliated or entitled to a social security
- Aged between 18 and 55
- Patients of both sexes suffering from bipolar disorders (DSM V criteria) whatever the subtype
- Stabilized from a point of view clinical and therapeutic
- Euthymic (score <7 at the Hamilton scale, and score <8 at Young's scale)
Show all 13Show fewer
- Must have given their informed consent before their participation in the study
- Be right-handed (score> 14 on the laterality scale)
- For control group:
- Affiliated or entitled to a social security
- Must have given their informed consent before their participation in the study
- Be right-handed (score> 14 on the lateral scale)
- Aged 18 to 55 matched by age (± 5 years), sex, and on the study level of patients (years of schooling after primary school ± 2 years)
Who cannot join
- For patients:
- Thymic acute decompensation
- Hamilton scale > 8, Young's scale > 9
- Montreal Cognitive Assessment (MOCA) <26
- History neurological pathology with cerebral impairment or serious somatic disease
- Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal) within 6 months.
Show all 14Show fewer
- IQ < 70
- History of head trauma
- For control group:
- History of head trauma
- Neurological pathology with cerebral impairment or serious somatic disease
- Psychotropic treatment
- Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal)
- IQ < 70
Trial locations and contacts
1 site in 1 country.
About this study
Based in an embodied approach of cognition, several studies have highlighted a direct link between perception of an object or an emotion and the associated motor responses. This study investigated in patients suffering from bipolar affective disorders whether the perception of emotional words involves an automatic sensorimotor simulation of approach and avoidance behaviors, and whether the perception of an object involves an automatic sensorimotor simulation of object prehension (affordance). We hypothesize that, in this pathology, low level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will be recruited. The main objective is the emergence of sensorimotor compatibility effects in approach-avoidance task with emotional stimuli (gain between compatible vs incompatible conditions).
- Conditions
- Bipolar Affective Disorder
- Being tested
- cognitive tasks + IQ + MINI, cognitive tasks
- Keywords
- Bipolar affective disorders, Cognition, Emotion, Embodiment, Sensorimotor, Simulation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive tasks + IQ + MINIBehavioural
Patients will perform different tasks:
- cognitive tasks : reaction time (Alert TEA, Zimmermann and Fimm, 2005) + Edinburgh laterality questionnaire (Oldfield,1971) + hamilton and young's scale (Tohen et al., 2009) + Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) + experimental task (approach/ avoidance and affordance task).
- Intelligence Quotient (IQ) test (PM38, Raven, 1960)
- Mini International Neuropsychiatric Interview (MINI, Van Vliet et al., 2006)
cognitive tasksBehavioural
Healthy volunteers will perform only the cognitive tasks = reaction time alert TEA, Zimmermann and Fimm, 2005 + Edinburgh laterality questionnaire (Oldfield, 1971) + experimental task (approach/ avoidance and affordance task).
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task Receives: Behavioral: cognitive tasks + IQ + MINI |
| control group | Active comparator | Healthy volunteers (Control group) who will perform cognitive tasks + experimental task Receives: Behavioral: cognitive tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
response time for avoidance and affordance task
Comparison of response time for avoidance and affordance task between patients and healthy volunteers.
Measured: Months 24
Secondary outcomes (3)
response time for affordance task
Comparison of response time for affordance task between patients and healthy volunteers.
Measured: Months 24
correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms
These informations were collected of the medical file.
Measured: Months 24
response time and cognitive tests
Correlation between response time and cognitive tests of patients and healthy volunteers.
Measured: Months 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start26 Oct 2017
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine MASSOUBRE, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249857
- Sponsor's protocol ID
- 1708056
- Other IDs
- 2017-A00917-46
- Status last verified
- Jan 2020
- First submitted
- 10 Aug 2017
- Last updated
- 9 Jan 2020
- 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 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
- ClinicalTrials.gov ID
- NCT03249857
- Acronym / sponsor ID
- 1708056
- Conditions
- Bipolar Affective Disorder
- Keywords
- Bipolar affective disorders, Cognition, Emotion, Embodiment, Sensorimotor, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 15 Aug 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.
Based in an embodied approach of cognition, several studies have highlighted a direct link between perception of an object or an emotion and the associated motor responses. This study investigated in patients suffering from bipolar affective disorders whether the perception of emotional words involves an automatic sensorimotor simulation of approach and avoidance behaviors, and whether the perception of an object involves an automatic sensorimotor simulation of object prehension (affordance). We hypothesize that, in this pathology, low level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will be recruited. The main objective is the emergence of sensorimotor compatibility effects in approach-avoidance task with emotional stimuli (gain between compatible vs incompatible conditions).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Behavioral: cognitive tasks + IQ + MINIPatients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task |
| control group | Active comparator | Behavioral: cognitive tasksHealthy volunteers (Control group) who will perform cognitive tasks + experimental task |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Affiliated or entitled to a social security
- Aged between 18 and 55
- Patients of both sexes suffering from bipolar disorders (DSM V criteria) whatever the subtype
- Stabilized from a point of view clinical and therapeutic
- Euthymic (score <7 at the Hamilton scale, and score <8 at Young's scale)
Key exclusion criteria (14 listed)
- Thymic acute decompensation
- Hamilton scale > 8, Young's scale > 9
- Montreal Cognitive Assessment (MOCA) <26
- History neurological pathology with cerebral impairment or serious somatic disease
- Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal) within 6 months.
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 |
|---|---|---|
| cognitive tasks + IQ + MINIPatients will perform different tasks: * cognitive tasks : reaction time (Alert TEA, Zimmermann and Fimm, 2005) + Edinburgh laterality questionnaire (Oldfield,1971) + hamilton and young's scale (Tohen et al., 2009) + Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) + experimental task (approach/ avoidance and affordance task). * Intelligence Quotient (IQ) test (PM38, Raven, 1960) * Mini International Neuropsychiatric Interview (MINI, Van Vliet et al., 2006) | Behavioural | patients |
| cognitive tasksHealthy volunteers will perform only the cognitive tasks = reaction time alert TEA, Zimmermann and Fimm, 2005 + Edinburgh laterality questionnaire (Oldfield, 1971) + experimental task (approach/ avoidance and affordance task). | Behavioural | control group |
Primary outcome
response time for avoidance and affordance task
Time frame: Months 24
Comparison of response time for avoidance and affordance task between patients and healthy volunteers.
3 secondary outcomes
response time for affordance task
Time frame: Months 24
correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms
Time frame: Months 24
response time and cognitive tests
Time frame: Months 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Bipolar Affective Disorder
Not yet recruiting
Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
Schizophenia Disorder, Severe Mental Illness
RecruitingObservational study
Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder
Schizophrenia, Bipolar Affective Disorder
Not yet recruitingObservational study
Chemokine Receptors on CD8+ T Cells in Patients With Bipolar Disorder
Bipolar Affective Disorders
RecruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
RecruitingPhase 1
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Schizophrenia, Schizo-Affective Disorder
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.
Catherine MASSOUBRE, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive tasks + IQ + MINI and cognitive tasks in people with Bipolar Affective Disorder, run by Centre Hospitalier Universitaire de Saint Etienne 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 13 inclusion and 14 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: finished, as of the sponsor's last update on 9 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
response time for avoidance and affordance task (time frame: Months 24). 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 9 Jan 2020; AzTrials last refreshed its copy on 31 Oct 2026.