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Status:

UNKNOWN

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

Lead Sponsor:

University Hospital, Rouen

Conditions:

Bipolar Anhedonic Depression

Eligibility:

All Genders

18-70 years

Phase:

NA

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 antidepre...

Eligibility Criteria

Inclusion

  • 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'âge 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-Åsberg 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

  • 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.

Key Trial Info

Start Date :

July 24 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2022

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT04456868

Start Date

July 24 2020

End Date

June 1 2022

Last Update

December 1 2020

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Rouen University Hospital

Rouen, France

2

CHSR du Rouvray

Saint-Étienne-du-Rouvray, France