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Clinical Trials/NCT04456868
NCT04456868
Terminated
Not Applicable

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

University Hospital, Rouen2 sites in 1 country36 target enrollmentAugust 24, 2020

Overview

Phase
Not Applicable
Intervention
Electroencephalogram
Conditions
Bipolar Anhedonic Depression
Sponsor
University Hospital, Rouen
Enrollment
36
Locations
2
Primary Endpoint
Difference between latency of P300 wave during encephalogram
Status
Terminated
Last Updated
2 months ago

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
August 24, 2020
End Date
August 10, 2023
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

Eligibility Criteria

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.

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

Arms & Interventions

Healthy volunteers

Healthy volunteers at least 18 years old and without a history of psychiatric or neurological disorders

Intervention: Electroencephalogram

Healthy volunteers

Healthy volunteers at least 18 years old and without a history of psychiatric or neurological disorders

Intervention: walking test

Healthy volunteers

Healthy volunteers at least 18 years old and without a history of psychiatric or neurological disorders

Intervention: Quality of life questionnaire

Anhedonic drug-resistant bipolar depression patient

Adult patients at least 18 years old with drug-resistant bipolar depression of the anhedonic type

Intervention: Electroencephalogram

Anhedonic drug-resistant bipolar depression patient

Adult patients at least 18 years old with drug-resistant bipolar depression of the anhedonic type

Intervention: walking test

Anhedonic drug-resistant bipolar depression patient

Adult patients at least 18 years old with drug-resistant bipolar depression of the anhedonic type

Intervention: Quality of life questionnaire

Anhedonic drug-resistant bipolar depression patient

Adult patients at least 18 years old with drug-resistant bipolar depression of the anhedonic type

Intervention: Position emission tomography

Non-anhedonic drug-resistant bipolar depression Pat

Adult patients at least 18 years old with drug-resistant bipolar depression of the non-anhedonic type

Intervention: Electroencephalogram

Non-anhedonic drug-resistant bipolar depression Pat

Adult patients at least 18 years old with drug-resistant bipolar depression of the non-anhedonic type

Intervention: walking test

Non-anhedonic drug-resistant bipolar depression Pat

Adult patients at least 18 years old with drug-resistant bipolar depression of the non-anhedonic type

Intervention: Quality of life questionnaire

Non-anhedonic drug-resistant bipolar depression Pat

Adult patients at least 18 years old with drug-resistant bipolar depression of the non-anhedonic type

Intervention: Position emission tomography

Mild to moderate Parkinson's disease patient

Adult patients at least 18 years of age with mild to moderate Parkinson's disease

Intervention: Electroencephalogram

Mild to moderate Parkinson's disease patient

Adult patients at least 18 years of age with mild to moderate Parkinson's disease

Intervention: walking test

Mild to moderate Parkinson's disease patient

Adult patients at least 18 years of age with mild to moderate Parkinson's disease

Intervention: Quality of life questionnaire

Mild to moderate Parkinson's disease patient

Adult patients at least 18 years of age with mild to moderate Parkinson's disease

Intervention: Position emission tomography

Outcomes

Primary Outcomes

Difference between latency of P300 wave during encephalogram

Time Frame: 1 hour after inclusion

Secondary Outcomes

  • Difference in walking speed during an 8 meter-walk test between the group of patients with bipolar drug-resistant depression of the anhedonic type and the other groups of subjects(2 hours after inclusion)
  • Stride length variation during an 8 meter-walk test between the group of patients with bipolar drug-resistant depression of the anhedonic type and the other groups of subjects(2 hours after inclusion)
  • Difference in presynaptic fixation of 18-Fluorodopa during positron emission tomography between the group of patients with drug-resistant bipolar depression of the anhedonic type and the other groups of patients(4 hours after inclusion)
  • Difference in the apathy assessment score performed by the Starkstein Apathy Scale (SAS) between the group of patients with drug-resistant bipolar depression of the anhedonic type and the other groups of subjects(30 minutes after inclusion)
  • Difference in frequency of melancholic characteristics meeting the criteria of DSM-5 between the group of patients with drug-resistant bipolar depression of the anhedonic type and the other groups of subjects(30 minutes after inclusion)
  • Difference in the Montgomery-Åsberg Depression Rating Scale (MADRS) assessment score for EDC severity between the group of patients with bipolar drug-resistant depression of the anhedonic type and the other groups of subjects(30 minutes after inclusion)
  • Difference in the score for evaluation of repetitive negative thinking by the Perseverative Thinking Questionnaire (PTQ) between the group of patients with bipolar drug-resistant(30 minutes after inclusion)
  • Difference in the score for the evaluation of parkinsonian symptoms (classification of Hoehn & Yahr) between the group of patients with bipolar drug-resistant depression of the anhedonic type and the other groups of patients(30 minutes after inclusion)

Study Sites (2)

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