Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03249857
Other study ID # 1708056
Secondary ID 2017-A00917-46
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2017
Est. completion date August 21, 2018

Study information

Verified date January 2020
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 21, 2018
Est. primary completion date August 21, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

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)

- 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)

Exclusion Criteria:

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.

- 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

Study Design


Intervention

Behavioral:
cognitive tasks + IQ + MINI
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 tasks
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).

Locations

Country Name City State
France Chu Saint-Etienne St Etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary response time for avoidance and affordance task Comparison of response time for avoidance and affordance task between patients and healthy volunteers. Months 24
Secondary response time for affordance task Comparison of response time for affordance task between patients and healthy volunteers. Months 24
Secondary 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. Months 24
Secondary response time and cognitive tests Correlation between response time and cognitive tests of patients and healthy volunteers. Months 24
See also
  Status Clinical Trial Phase
Completed NCT03275714 - Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder N/A
Completed NCT01722344 - Improving Work Outcome for People With Severe Mental Illness N/A
Completed NCT01431092 - Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia Phase 4
Completed NCT01315028 - Bipolar Intervention Study: Cognitive Interpersonal Therapy N/A
Terminated NCT00805493 - Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder Phase 2
Completed NCT00436020 - rTMS in the Treatment of Bipolar Depression N/A
Withdrawn NCT00397605 - Cannabinoids in Bipolar Affective Disorder N/A
Recruiting NCT05860101 - Compassion-Focused Therapy for Distressing Mood Swings: A Case Series N/A
Recruiting NCT06176456 - Personalized Prospective Study Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia N/A
Terminated NCT03310593 - Cannabidiol as an Adjunctive Treatment for Bipolar Depression Phase 2/Phase 3
Recruiting NCT05406414 - The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems N/A
Completed NCT02773108 - Somatic Comorbidities in Psychiatric Patients
Recruiting NCT00474357 - Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy N/A
Withdrawn NCT00327756 - Mitochondrial Dysfunction in the Pathophysiology and Treatment of Bipolar Disorder Phase 2
Completed NCT02453217 - The Potential Efficacy of the Chinese Health Improvement Profile- A Pilot Clustered Randomised Controlled Trial N/A
Completed NCT05683431 - Using Neuroplasticity-Based Computerized Training to Improve Emotion Regulation in Bipolar Disorder (BRAINS) N/A
Not yet recruiting NCT05915312 - Exosome for Early Diagnosis of Bipolar Affective Disorder
Completed NCT00186758 - Transcranial Magnetic Stimulation in Bipolar Depression Phase 4
Completed NCT02083978 - Bipolar Research Study Using MR Imaging N/A
Completed NCT00683709 - Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder Phase 4