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

NCT04456868 | Terminated

• 1 other identifier: 2018/0426/HP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Conditions

Bipolar Anhedonic Depression

Outcome Measures

Primary Outcomes (1)

• Difference between latency of P300 wave during encephalogram

  1 hour after inclusion

Secondary Outcomes (8)

• 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

Study Arms (4)

Healthy volunteers

ACTIVE COMPARATOR

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

Behavioral: Electroencephalogram; Behavioral: walking test; Behavioral: Quality of life questionnaire

Anhedonic drug-resistant bipolar depression patient

EXPERIMENTAL

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

Behavioral: Electroencephalogram; Behavioral: walking test; Behavioral: Quality of life questionnaire; Procedure: Position emission tomography

Non-anhedonic drug-resistant bipolar depression Pat

ACTIVE COMPARATOR

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

Behavioral: Electroencephalogram; Behavioral: walking test; Behavioral: Quality of life questionnaire; Procedure: Position emission tomography

Mild to moderate Parkinson's disease patient

ACTIVE COMPARATOR

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

Behavioral: Electroencephalogram; Behavioral: walking test; Behavioral: Quality of life questionnaire; Procedure: Position emission tomography

Interventions

Electroencephalogram BEHAVIORAL

Electroencephalogram will be done for P300 wave assessment

Anhedonic drug-resistant bipolar depression patient; Healthy volunteers; Mild to moderate Parkinson's disease patient; Non-anhedonic drug-resistant bipolar depression Pat

Quality of life questionnaire BEHAVIORAL

Starkstein Apathy Scale, DSM-5 criteria, Montgomery-Åsberg Depression Rating Scale, Perseverative Thinking Questionnaire, classification of Hoehn \& Yahr

Anhedonic drug-resistant bipolar depression patient; Healthy volunteers; Mild to moderate Parkinson's disease patient; Non-anhedonic drug-resistant bipolar depression Pat

Position emission tomography PROCEDURE

Position emission tomography will be done for

Anhedonic drug-resistant bipolar depression patient; Mild to moderate Parkinson's disease patient; Non-anhedonic drug-resistant bipolar depression Pat

walking test BEHAVIORAL

8-Meter walking test will be done for gait parameter assessment

Anhedonic drug-resistant bipolar depression patient; Healthy volunteers; Mild to moderate Parkinson's disease patient; Non-anhedonic drug-resistant bipolar depression Pat

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patient having a normal neurological examination.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (2)

Rouen University Hospital

Rouen, France

Location

CHSR du Rouvray

Saint-Étienne-du-Rouvray, France

Location

Study Officials

• Marie-Laure WELTER, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: July 7, 2020
• Study Start: August 24, 2020
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)