Neurophysiological Markers in the Depressive Episode Characterized by Anhedonic Drug Resistance: Evaluation of Motor Skills and P300 Wave

  • STATUS
    Recruiting
  • End date
    Jun 27, 2022
  • participants needed
    65
  • sponsor
    University Hospital, Rouen
Updated on 27 January 2021

Summary

Depression is currently the leading cause of disability and suicide death worldwide. Several studies, however, have shown that a significant proportion of patients do not respond to standard antidepressants, especially since their symptomatology is dominated by anhedonia or psychomotor retardation reflecting central dopaminergic dysfunction. In order to improve the efficiency and speed of the antidepressant response, it seems essential to highlight this dopaminergic dysfunction, by defining a P300 wave profile specific to the subtype of depressed patients with anhedonic phenotype to whom personalized treatment targeting dopaminergic transmission could in the future be proposed earlier. The investigators therefore wish to highlight an increase in the latency time of P300 and a modification of motor skills (of the walking cycle and of the movement of the hands), without modification of the dopaminergic transmission measured by PETScan, specific to the sub-type of depressive patients, resistant to at least 2 antidepressants of different classes with an anhedonia score> 5/14 on the SHAPS scale. The increased latency of P300 could then be used in the future as a predictive biomarker of resistance to conventional antidepressant treatments specific to this population of anhedonic depressed patients

Details
Condition Bipolar Anhedonic Depression
Treatment Quality of Life questionnaire, Walking test, electroencephalogram, Position emission tomography
Clinical Study IdentifierNCT04456868
SponsorUniversity Hospital, Rouen
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy volunteers
Person who is 18 years old and 70 years old
Subject without neurological history
Subject without psychiatric history in the semi-structured interview Mini International Neuropsychiatric Interview (MINI)
Subject having read and understood the newsletter and signed the consent form
Subject affiliated to a social security scheme
Subject capable of understanding spoken and written French
Woman of reproductive age with effective contraception as defined by the WHO, for at least three months or postmenopausal
Patients with drug-resistant bipolar anhedonic depression
Patient whose age is 18 years and 70 years
Patient with depression meeting DSM-5 criteria (Appendix 4) evolving in the context of bipolar disorder
Patient with a resistance level greater than or equal to 1 according to the Pacchiarotti classification
Patient with an SHAPS anhedonia score greater than 5/14
Patient with no other psychiatric pathology in the semi-structured interview Mini International Neuropsychiatric Interview (MINI)
Stable lithium treatment in the 7 days preceding the inclusion visit
Patient who has not received treatment with electroconvulsive therapy in the 2 months preceding the inclusion visit
Patient having a normal neurological examination
Patient who has read and understood the information letter and signed the consent form
Patient affiliated to a social security scheme
Patient able to understand spoken and written French
Woman of reproductive age with effective contraception as defined by the WHO, for at least three months or postmenopausal.Patient dont l'ge est 18 ans et 70 ans
Patients with drug-resistant bipolar depression of the non-anhedonic type
Patient whose age is 18 years and 70 years
Presence of a depression meeting the criteria of DSM-5 (Annex 4) evolving in the context of bipolar disorder
Patient with a resistance level greater than or equal to 1 according to the Pacchiarotti classification
Patient with SHAPS anhedonia score less than or equal to 3/14
Absence of another psychiatric pathology in the semi-structured interview Mini International Neuropsychiatric Interview (MINI)
Stable lithium treatment in the 7 days preceding the inclusion visit
Patient who has not received treatment with electroconvulsive therapy in the 2 months preceding the inclusion visit
Patient having a normal neurological examination
Patient who has read and understood the information letter and signed the consent form
Patient affiliated to a social security scheme
Patient able to understand spoken and written French
Woman of reproductive age with effective contraception as defined by the WHO, for at least three months
Patients with Parkinson's disease
Patient whose age is 18 years and 70 years
Patient with idiopathic Parkinson's disease as defined by the diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) (Annex 8)
Patient with Parkinson's disease stage less than 3 (mild or moderate severity) according to the classification of Hoehn & Yahr (Annex 7)
Patient treated with L-DOPA associated with a dopa-decarboxylase inhibitor (DDC) and who has not changed antiparkinsonian treatment for at least 1 month before the inclusion visit
Patient with no neurological disorders other than those induced by Parkinson's disease
Patient without depression defined by a score less than or equal to 8 on the Montgomery-sberg Depression Rating Scale (MADRS) (Annex 10)
Patient with no psychiatric pathology at the semi-structured interview Mini International Neuropsychiatric Interview (MINI) (Annex 9)
Patient who has read and understood the information letter and signed the consent form
Patient affiliated to a social security scheme
Patient able to understand spoken and written French
Woman of childbearing age with effective contraception as defined by the WHO, for at least three months

Exclusion Criteria

Healthy volunteers
Person with a psychiatric disorder in the semi-structured interview Mini International Neuropsychiatric Interview (MINI) (Annex 9)
Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship
Subjects with poor understanding of spoken or written French
Existence of a neurological, rheumatological, orthopedic or psychiatric history, presence of a severe progressive pathology which can modify brain activity or gait parameters
Woman of childbearing age not taking effective contraception according to the WHO definition (estrogen-progestogens or intrauterine device or tubal ligation), pregnant (positive urine pregnancy test) or breastfeeding
Taking unauthorized treatment during the study and
In the 7 days preceding inclusion for dopamine agonists, MAOIs, antiepileptics, antidepressants, benzodiazepines and L-DOPA combined with a dopa decarboxylase (DDC) or catechol-O-methyl transferase inhibitor (COMT)
In the 28 days preceding inclusion for amphetamines, antivirals, antiemetics
In the 2 months preceding inclusion for electroconvulsive therapy
In the 6 months prior to inclusion for antipsychotics
Dependence on a substance other than nicotine
Patients with drug-resistant bipolar anhedonic depression
Patient with depression with psychotic characteristics
Patient deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship
Subjects with poor understanding of spoken or written French
Patient with SHAPS anhedonia score less than or equal to 5/14 (Annex 2)
Patient with a neurological, rheumatological, orthopedic or psychiatric history, presence of a severe progressive pathology which can modify brain activity or gait parameters
Woman of childbearing age not taking effective contraception according to the WHO definition (estrogen-progestogens or intrauterine device or tubal ligation), pregnant (positive urine pregnancy test) or breastfeeding
Subject with a history of allergy or hypersensitivity to the active substance in DOPACIS (18Fluorodopa) or to any of its excipients
Taking unauthorized treatment during the study and
In the 7 days preceding inclusion for dopamine agonists, MAOIs, antiepileptics, antidepressants, benzodiazepines and L-DOPA combined with a dopa decarboxylase (DDC) or catechol-O-methyl transferase inhibitor (COMT)
In the 28 days preceding inclusion for amphetamines, antivirals, antiemetics
In the 2 months preceding inclusion for electroconvulsive therapy
In the 6 months prior to inclusion for antipsychotics
Dependence on a substance other than nicotine
Patients with drug-resistant bipolar depression of the non-anhedonic type
Pa Patient with depression with psychotic characteristics
Patient deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship
Subjects with poor understanding of spoken or written French
Patient with SHAPS anhedonia score less than or equal to 5/14 (Annex 2)
Patient with a neurological, rheumatological, orthopedic or psychiatric history, presence of a severe progressive pathology which can modify brain activity or gait parameters
Woman of childbearing age not taking effective contraception according to the WHO definition (estrogen-progestogens or intrauterine device or tubal ligation), pregnant (positive urine pregnancy test) or breastfeeding
Subject with a history of allergy or hypersensitivity to the active substance in DOPACIS (18Fluorodopa) or to any of its excipients
Taking unauthorized treatment during the study and
In the 7 days preceding inclusion for dopamine agonists, MAOIs, antiepileptics, antidepressants, benzodiazepines and L-DOPA combined with a dopa decarboxylase (DDC) or catechol-O-methyl transferase inhibitor (COMT)
In the 28 days preceding inclusion for amphetamines, antivirals, antiemetics
In the 2 months preceding inclusion for electroconvulsive therapy
In the 6 months prior to inclusion for antipsychotics
Dependence on a substance other than nicotine
Patients with Parkinson's disease
Patient with depression
Patient deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship
Subjects with poor understanding of spoken or written French
Severe form of Parkinson's disease with a Hoehn and Yhar upper or equal 4 (Annex 7)
Patient with other neurological, rheumatological, orthopedic or psychiatric history, presence of a severe progressive pathology which can modify brain activity or gait parameters
Woman of childbearing age not taking effective contraception according to the WHO definition (estrogen-progestogens or intrauterine device or tubal ligation), pregnant (positive urine pregnancy test) or breastfeeding
Subject with a history of allergy or hypersensitivity to the active substance in DOPACIS (18Fluorodopa) or to any of its excipients
Taking unauthorized treatment during the study and
In the 7 days preceding inclusion for dopamine agonists, MAOIs, antiepileptics, antidepressants, benzodiazepines and L-DOPA combined with a dopa decarboxylase (DDC) or catechol-O-methyl transferase inhibitor (COMT)
In the 28 days preceding inclusion for amphetamines, antivirals, antiemetics
In the 2 months preceding inclusion for electroconvulsive therapy
In the 6 months prior to inclusion for antipsychotics
Dependence on a substance other than nicotine
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