Bipolar Anhedonic DepressionPHYDDOPANCT04456868
Neurophysiological Markers in the Depressive Episode Characterized by Anhedonic Drug Resistance: Evaluation of Motor Skills and P300 Wave
A study testing Electroencephalogram, walking test and Quality of life questionnaire in people with Bipolar Anhedonic Depression, run by University Hospital, Rouen at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Anhedonic Depression
- What is being tested?
- Electroencephalogram, walking test and Quality of life questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Aug 2020to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Rouen University Hospital
Rouen
CHSR du Rouvray
Saint-Étienne-du-Rouvray
About this study
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
- Being tested
- Electroencephalogram, walking test, Quality of life questionnaire, Position emission tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalogramBehavioural
Electroencephalogram will be done for P300 wave assessment
walking testBehavioural
8-Meter walking test will be done for gait parameter assessment
Quality of life questionnaireBehavioural
Starkstein Apathy Scale, DSM-5 criteria, Montgomery-Åsberg Depression Rating Scale, Perseverative Thinking Questionnaire, classification of Hoehn \& Yahr
Position emission tomographyProcedure or surgery
Position emission tomography will be done for
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Active comparator | Healthy volunteers at least 18 years old and without a history of psychiatric or neurological disorders Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Electroencephalogram; Behavioral: walking test; Behavioral: Quality of life questionnaire; Procedure: Position emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between latency of P300 wave during encephalogram
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Starkstein Apathy Scale (SAS) is scored from 0 to 42 42 = maximum severity of apathy ; Score <14 define a absence apathy Score ≥14 define the presence of a clinically significant apathy
Measured: 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
melancholic characteristics of DSM-5 has 8 items (2 A catory and 6 B category) Presence of melancholic characteristics is defined by a presence of at least one item from A category and the presence of at least 3 items from B category Absence of melancholic characteristics is defined by no item from A category and less than 3 items from B category
Measured: 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
Montgomery-Åsberg Depression Rating Scale (MADRS) 10 items scored from 0 to 6 (6 correspond to maximal severity of the item). The score varies from 0 to 60 (60 = maximal severity of intensity of depression).
Total score ≥ 8/60 defines a clinically significant intensity of depression. Total score > 30/60 defines a major intensity of depression
Measured: 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
the Perseverative Thinking Questionnaire (PTQ) has 15 items scored from 0 (never) to 5 (almost always = maximum severity of the dimension evaluated by the item). The score varies from 0 (absence of repetitive negative thinking) to 60 (maximum severity of the intensity of repetitive negative thinking)
Measured: 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
The score varies from 0 (no sign) to 5 (worse disability)
Measured: 30 minutes after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start24 Aug 2020
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Why it stopped: Inability to include additional patients in the arms with depression
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Anhedonic DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Laure WELTER, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456868
- Sponsor's protocol ID
- 2018/0426/HP
- Acronym
- PHYDDOPA
- Status last verified
- Feb 2026
- First submitted
- 16 Mar 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Markers in the Depressive Episode Characterized by Anhedonic Drug Resistance: Evaluation of Motor Skills and P300 Wave
- ClinicalTrials.gov ID
- NCT04456868
- Acronym / sponsor ID
- PHYDDOPA / 2018/0426/HP
- Conditions
- Bipolar Anhedonic Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to include additional patients in the arms with depression
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Active comparator | Behavioral: Electroencephalogram, Behavioral: walking test, Behavioral: Quality of life questionnaireHealthy volunteers at least 18 years old and without a history of psychiatric or neurological disorders |
| Anhedonic drug-resistant bipolar depression patient | Experimental | Behavioral: Electroencephalogram, Behavioral: walking test, Behavioral: Quality of life questionnaire, Procedure: Position emission tomographyAdult patients at least 18 years old with drug-resistant bipolar depression of the anhedonic type |
| Non-anhedonic drug-resistant bipolar depression Pat | Active comparator | Behavioral: Electroencephalogram, Behavioral: walking test, Behavioral: Quality of life questionnaire, Procedure: Position emission tomographyAdult patients at least 18 years old with drug-resistant bipolar depression of the non-anhedonic type |
| Mild to moderate Parkinson's disease patient | Active comparator | Behavioral: Electroencephalogram, Behavioral: walking test, Behavioral: Quality of life questionnaire, Procedure: Position emission tomographyAdult patients at least 18 years of age with mild to moderate Parkinson's disease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (46 listed)
- 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
Key exclusion criteria (54 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroencephalogramElectroencephalogram will be done for P300 wave assessment | Behavioural | Anhedonic drug-resistant bipolar depression patient, Healthy volunteers, Mild to moderate Parkinson's disease patient, Non-anhedonic drug-resistant bipolar depression Pat |
| walking test8-Meter walking test will be done for gait parameter assessment | Behavioural | 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 questionnaireStarkstein Apathy Scale, DSM-5 criteria, Montgomery-Åsberg Depression Rating Scale, Perseverative Thinking Questionnaire, classification of Hoehn \& Yahr | Behavioural | Anhedonic drug-resistant bipolar depression patient, Healthy volunteers, Mild to moderate Parkinson's disease patient, Non-anhedonic drug-resistant bipolar depression Pat |
| Position emission tomographyPosition emission tomography will be done for | Procedure or surgery | Anhedonic drug-resistant bipolar depression patient, Mild to moderate Parkinson's disease patient, Non-anhedonic drug-resistant bipolar depression Pat |
Primary outcome
Difference between latency of P300 wave during encephalogram
Time frame: 1 hour after inclusion
8 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 minutes after inclusion
Results and safety
The study was stopped early (reason given: Inability to include additional patients in the arms with depression). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Laure WELTER, Pr principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram, walking test and Quality of life questionnaire in people with Bipolar Anhedonic Depression, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to include additional patients in the arms with depression). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between latency of P300 wave during encephalogram (time frame: 1 hour after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.