Bipolar DisorderBIMARNCT05161546
Study of Bipolar Disorders and Retinal Electrophysiological Markers
A study testing EEG and ERG measurements (Retinaute®, BioSerenity), Actigraphy (Motion Watch 8®, CamNtech) and Neuropsychological assessments in people with Bipolar Disorder, run by Centre Psychothérapique de Nancy at 1 site in France.
Trial summary
The BIMAR study aims to compare electrophysiological data measured with electroretinogram (ERG) and electroencephalogram (EEG) between a group of euthymic patients with bipolar disorder (BD) and a group of healthy controls subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- EEG and ERG measurements (Retinaute®, BioSerenity), Actigraphy (Motion Watch 8®, CamNtech) and Neuropsychological assessments
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2022to 8 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- been diagnosed with BD according to the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) diagnostic criteria using the Mini International Neuropsychiatric Interview (MINI)
- currently euthymic for at least 3 months prior to the study, as defined by a score below 10 on the Montgomery-Asberg Depression Rating Scale (MADRS) which assesses depression and by a score below 8 on the Young Mania Rating Scale (YMRS) which assesses mania
- age 18 or more
- Healthy volunteers:
- not suffer from a personal psychiatric pathology verified with the MINI
Show all 18Show fewer
- age 18 or more
- Exclusion criteria for all participants (patients and healthy volunteers):
- suffer from psychiatric pathology or substance use disorders according to DSM-IV criteria measured with the MINI, excluding BD for the patient group
- suffer from neurological or retinal pathology
- having a shift work or a get-lag in the last 15 days
- criteria incompatible with the use of the virtual reality headset (Retinaute®,BioSerenity) like having an allergy to one of the components of the textile
- persons treated by sismotherapy during the past year
- persons with an uncorrected visual impairment or disabling hearing impairment that does not allow neuropsychological tests to be performed
- subjects with an intellectual disability making it difficult to participate in the study or to understand and follow informations provided to them
- adults legally protected
- pregnant or breastfeeding women
- subjects already participating in another interventional trial
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The BIMAR study aims to compare electrophysiological data measured with electroretinogram (ERG) and electroencephalogram (EEG) between a group of euthymic patients with bipolar disorder (BD) and a group of healthy controls subjects.
Secondarily, the investigators also want to:
Read more
- Compare combined electrophysiological measurements with ERG and EEG between the two groups.
- Identify relations between clinical, neuropsychological and circadian phenotypes in patients with BD and electrophysiological measurements measured with ERG and EEG.
The main hypothesis of the investigators is that differences exist in the ERG and EEG measurements between subjects with BD and healthy subjects. Those differences could be identified as candidate markers for BD which, if confirmed in later studies, could be used in current practice to guide the management of patients with BD.
Read the detailed description
Bipolar disorders (BD) is a common, chronic and disabling psychiatric condition. In addition to being characterized by significant clinical heterogeneity, notable disturbances of sleep and cognitive function are frequently observed in all phases of the disease. Currently, there is no readily available biomarker in current clinical practice to help diagnose or predict the disease course. Thus, identification of biomarkers in BD is today a major challenge. In this context, the study of electrophysiological biomarkers based on electroretinogram (ERG) and electroencephalogram (EEG) measurements in BD seems highly promising. The BiMAR study aims to compare electrophysiological data measured with ERG and EEG between a group of euthymic patients with BD and a group of healthy control subjects. Secondarily, the investigators will also describe the existing potential relationship between clinical, sleep and neuropsychological phenotypes of patients and electrophysiological data.
The BiMAR study is a comparative and monocentric study carried out at the Expert Center for BD in Nancy, France. In total, 70 euthymic adult patients with BD and 70 healthy control subjects will be recruited. Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation to all participants. Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. The primary outcome will be electrophysiological measurements with ERG flash and pattern. Secondary outcomes will be EEG data, sleep settings, clinical and neuropsychological assessments. For patients only, a complementary ancillary study, carried out at the University Hospital of Nancy, will be proposed to assess the retinal structure and microvascularization using Optical Coherence Tomography. Recruitment will begin in December 2021 and will continue until the end of June 2023.
The BiMAR study will contribute to identifying candidate ERG electrophysiological markers for helping the diagnosis of BD and identify subgroups of patients with different clinical profiles. Eventually, this would allow earlier diagnosis and personalized therapeutic interventions.
- Conditions
- Bipolar Disorder
- Being tested
- EEG and ERG measurements (Retinaute®, BioSerenity), Actigraphy (Motion Watch 8®, CamNtech), Neuropsychological assessments, Optical Coherence Tomography (OCT)
- Keywords
- bipolar disorder, biomarker, electroretinogram, electroencephalogram, neurocognition, actigraphy, retina
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG and ERG measurements (Retinaute®, BioSerenity)Device
The Retinaute® is a portable medical device developed by BioSerenity, France, for performing flash and pattern ERG. It comes in the form of a virtual reality headset, which can be used in outpatient facilities. It is non-invasive and uses skin electrodes for the collection of parameters.
ERG signals will be supplemented with 4 EEG channels, via cup electrodes applied to the skull and allowing the concomitant performance of an EEG.
Actigraphy (Motion Watch 8®, CamNtech)Device
Actigraphy is an ecological and non-invasive method allowing a reliable characterization of the sleep/wake cycle. It is a portable system for continuously measuring the motor activity of an individual and appreciating the alternation of activity periods (wakefulness) and rest periods (sleep).
An actigraph (MotionWatch8®, CamNtech) looks like a wristwatch that will be worn continuously, by convention on the wrist of the non-dominant hand, over periods ranging from several days to several weeks (here 21 days). Actigraphy does not present a known risk.
Neuropsychological assessmentsBehavioural
The purpose of this assessment is to establish a cognitive profile for each participant. It uses a series of tests widely described in the literature and commonly used today.
Optical Coherence Tomography (OCT)Device
The Spectral Domain Optical Coherence Tomography (SD-OCT) is a modern ocular imaging process using infrared radiation and allowing to obtain in a few seconds, and in a non-invasive way, images in section of the eye. The OCT-Angiography (OCT-A) module increments on the OCT. It can detect the movement of the blood elements from sequential SD-OCT slices taken at the same location of the retina and obtain a map of the retinal and choroidal vessels, without injection of fluorescent dye. The device used for both exams will be the OCT spectral RS 3000 Advance 2 + Angioscan (NIDEK, Gamagori, Japan). SD-OCT and OCT-A examinations are fast, painless, non-contact and last less than a minute. There is no particular risk.
| Study group | Role | What they receive |
|---|---|---|
| patients with bipolar disorder (BD) | Experimental | Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation (first visit).
Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit.
Between day 23 and day 28 (after the second visit), patients will be offered to assess the retinal structure and microvascularization using Spectral Domain Optical Coherence Tomography (SD-OCT) and OCT-Angiography (OCT-A). Receives: Device: EEG and ERG measurements (Retinaute®, BioSerenity); Device: Actigraphy (Motion Watch 8®, CamNtech); Behavioral: Neuropsychological assessments; Device: Optical Coherence Tomography (OCT) |
| healthy volunteers | Active comparator | Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation (first visit).
Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. Receives: Device: EEG and ERG measurements (Retinaute®, BioSerenity); Device: Actigraphy (Motion Watch 8®, CamNtech); Behavioral: Neuropsychological assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of amplitude measured with flash and pattern electroretinogram
amplitude in microvolt
Measured: Day 0 (=day of inclusion)
Modification of implicite time measured with flash and pattern electroretinogram
implicite time in millisecond
Measured: Day 0 (=day of inclusion)
Secondary outcomes (10)
Modification of amplitude measured with electroencephalogram
amplitude of the P100, N170 and N200 waves amplitude in microvolt
Measured: Day 0 (=day of inclusion)
Modification of latency measured with electroencephalogram
latency of the P100, N170 and N200 waves latency in millisecond
Measured: Day 0 (=day of inclusion)
Actigraphy
evaluation of sleep/wake cycles
Measured: from Day1 to Day21
Sleep diary
self reported tool of sleeping and waking times
Measured: from Day 1 to Day 21
Visual Object and Space Perception battery (VOSP)
test of visual cognition
Measured: visit n ° 2 (=between Day 22 and Day 27)
California Verbal Learning Test (CVLT)
assessment of verbal episodic memory
Measured: visit n ° 2 (=between Day 22 and Day 27)
Continuous Performance Task (CPT-III)
test of sustained attention
Measured: visit n ° 2 (=between Day22 and Day27)
Verbal Fluency Task
test of verbal functioning
Measured: visit n ° 2 (=between Day 22 and Day 27)
Test of Attention Assessment (TAP)
test of attentional performance
Measured: visit n ° 2 (=between Day 22 and Day 27)
Montreal Cognitive Assessment (MoCA)
screening assessment for detecting cognitive impairment
Measured: visit n ° 2 (=between Day 22 and Day 27)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start18 Jan 2022
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Why it stopped: Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The BiMAR study is an open-label and non-randomized comparative monocentric study applied in psychiatry and neuroscience. This research included two groups of adult subjects: a group of patients with BD in the euthymic phase and a group of healthy control subjects.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Collaborators
- BioSerenity
- Responsible party
- Sponsor
- Investigators
- Thomas SCHWITZER, MD, PhD, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161546
- Sponsor's protocol ID
- RIPH 2021-03
- Other IDs
- IDRCB 2021-A01644-37
- Acronym
- BIMAR
- Status last verified
- Aug 2024
- First submitted
- 28 Sep 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwitzer T, Schwan R, Bubl E, Lalanne L, Angioi-Duprez K, Laprevote V. Looking into the brain through the retinal ganglion cells in psychiatric disorders: A review of evidences. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jun 2;76:155-162. doi: 10.1016/j.pnpbp.2017.03.008. Epub 2017 Mar 20.
PubMed 28336492Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. Study of retinal structure and function in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature. J Fr Ophtalmol. 2020 May;43(5):e157-e166. doi: 10.1016/j.jfo.2020.04.004. Epub 2020 May 4.
PubMed 32381369Hebert M, Merette C, Gagne AM, Paccalet T, Moreau I, Lavoie J, Maziade M. The Electroretinogram May Differentiate Schizophrenia From Bipolar Disorder. Biol Psychiatry. 2020 Feb 1;87(3):263-270. doi: 10.1016/j.biopsych.2019.06.014. Epub 2019 Jun 27.
PubMed 31443935Gross G, Tursini K, Albuisson E, Angioi-Duprez K, Conart JB, Louis Dorr V, Schwan R, Schwitzer T. Bipolar disorders and retinal electrophysiological markers (BiMAR): Study protocol for a comparison of electroretinogram measurements between subjects with bipolar disorder and a healthy control group. Front Psychiatry. 2022 Sep 8;13:960512. doi: 10.3389/fpsyt.2022.960512. eCollection 2022.
PubMed 36159928
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bipolar Disorders and Retinal Electrophysiological Markers
- ClinicalTrials.gov ID
- NCT05161546
- Acronym / sponsor ID
- BIMAR / RIPH 2021-03
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, biomarker, electroretinogram, electroencephalogram, neurocognition, actigraphy, retina
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Collaborators
- BioSerenity
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 17 Dec 2021 (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.
The BIMAR study aims to compare electrophysiological data measured with electroretinogram (ERG) and electroencephalogram (EEG) between a group of euthymic patients with bipolar disorder (BD) and a group of healthy controls subjects.
Secondarily, the investigators also want to:
- Compare combined electrophysiological measurements with ERG and EEG between the two groups.
- Identify relations between clinical, neuropsychological and circadian phenotypes in patients with BD and electrophysiological measurements measured with ERG and EEG.
The main hypothesis of the investigators is that differences exist in the ERG and EEG measurements between subjects with BD and healthy subjects. Those differences could be identified as candidate markers for BD which, if confirmed in later studies, could be used in current practice to guide the management of patients with BD.
Detailed description
Bipolar disorders (BD) is a common, chronic and disabling psychiatric condition. In addition to being characterized by significant clinical heterogeneity, notable disturbances of sleep and cognitive function are frequently observed in all phases of the disease. Currently, there is no readily available biomarker in current clinical practice to help diagnose or predict the disease course. Thus, identification of biomarkers in BD is today a major challenge. In this context, the study of electrophysiological biomarkers based on electroretinogram (ERG) and electroencephalogram (EEG) measurements in BD seems highly promising. The BiMAR study aims to compare electrophysiological data measured with ERG and EEG between a group of euthymic patients with BD and a group of healthy control subjects. Secondarily, the investigators will also describe the existing potential relationship between clinical, sleep and neuropsychological phenotypes of patients and electrophysiological data.
The BiMAR study is a comparative and monocentric study carried out at the Expert Center for BD in Nancy, France. In total, 70 euthymic adult patients with BD and 70 healthy control subjects will be recruited. Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation to all participants. Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. The primary outcome will be electrophysiological measurements with ERG flash and pattern. Secondary outcomes will be EEG data, sleep settings, clinical and neuropsychological assessments. For patients only, a complementary ancillary study, carried out at the University Hospital of Nancy, will be proposed to assess the retinal structure and microvascularization using Optical Coherence Tomography. Recruitment will begin in December 2021 and will continue until the end of June 2023.
The BiMAR study will contribute to identifying candidate ERG electrophysiological markers for helping the diagnosis of BD and identify subgroups of patients with different clinical profiles. Eventually, this would allow earlier diagnosis and personalized therapeutic interventions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The BiMAR study is an open-label and non-randomized comparative monocentric study applied in psychiatry and neuroscience. This research included two groups of adult subjects: a group of patients with BD in the euthymic phase and a group of healthy control subjects.
| Arm | Type | Receives |
|---|---|---|
| patients with bipolar disorder (BD) | Experimental | Device: EEG and ERG measurements (Retinaute®, BioSerenity), Device: Actigraphy (Motion Watch 8®, CamNtech), Behavioral: Neuropsychological assessments, Device: Optical Coherence Tomography (OCT)Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation (first visit). Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. Between day 23 and day 28 (after the second visit), patients will be offered to assess the retinal structure and microvascularization using Spectral Domain Optical Coherence Tomography (SD-OCT) and OCT-Angiography (OCT-A). |
| healthy volunteers | Active comparator | Device: EEG and ERG measurements (Retinaute®, BioSerenity), Device: Actigraphy (Motion Watch 8®, CamNtech), Behavioral: Neuropsychological assessmentsElectrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation (first visit). Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients:
- Healthy volunteers:
- suffer from psychiatric pathology or substance use disorders according to DSM-IV criteria measured with the MINI, excluding BD for the patient group
- suffer from neurological or retinal pathology
- having a shift work or a get-lag in the last 15 days
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EEG and ERG measurements (Retinaute®, BioSerenity)The Retinaute® is a portable medical device developed by BioSerenity, France, for performing flash and pattern ERG. It comes in the form of a virtual reality headset, which can be used in outpatient facilities. It is non-invasive and uses skin electrodes for the collection of parameters. ERG signals will be supplemented with 4 EEG channels, via cup electrodes applied to the skull and allowing the concomitant performance of an EEG. | Device | healthy volunteers, patients with bipolar disorder (BD) |
| Actigraphy (Motion Watch 8®, CamNtech)Actigraphy is an ecological and non-invasive method allowing a reliable characterization of the sleep/wake cycle. It is a portable system for continuously measuring the motor activity of an individual and appreciating the alternation of activity periods (wakefulness) and rest periods (sleep). An actigraph (MotionWatch8®, CamNtech) looks like a wristwatch that will be worn continuously, by convention on the wrist of the non-dominant hand, over periods ranging from several days to several weeks (here 21 days). Actigraphy does not present a known risk. | Device | healthy volunteers, patients with bipolar disorder (BD) |
| Neuropsychological assessmentsThe purpose of this assessment is to establish a cognitive profile for each participant. It uses a series of tests widely described in the literature and commonly used today. | Behavioural | healthy volunteers, patients with bipolar disorder (BD) |
| Optical Coherence Tomography (OCT)The Spectral Domain Optical Coherence Tomography (SD-OCT) is a modern ocular imaging process using infrared radiation and allowing to obtain in a few seconds, and in a non-invasive way, images in section of the eye. The OCT-Angiography (OCT-A) module increments on the OCT. It can detect the movement of the blood elements from sequential SD-OCT slices taken at the same location of the retina and obtain a map of the retinal and choroidal vessels, without injection of fluorescent dye. The device used for both exams will be the OCT spectral RS 3000 Advance 2 + Angioscan (NIDEK, Gamagori, Japan). SD-OCT and OCT-A examinations are fast, painless, non-contact and last less than a minute. There is no particular risk. | Device | patients with bipolar disorder (BD) |
Primary outcome
Modification of amplitude measured with flash and pattern electroretinogram
Time frame: Day 0 (=day of inclusion)
amplitude in microvolt
Modification of implicite time measured with flash and pattern electroretinogram
Time frame: Day 0 (=day of inclusion)
implicite time in millisecond
10 secondary outcomes
Modification of amplitude measured with electroencephalogram
Time frame: Day 0 (=day of inclusion)
Modification of latency measured with electroencephalogram
Time frame: Day 0 (=day of inclusion)
Actigraphy
Time frame: from Day1 to Day21
Sleep diary
Time frame: from Day 1 to Day 21
Visual Object and Space Perception battery (VOSP)
Time frame: visit n ° 2 (=between Day 22 and Day 27)
California Verbal Learning Test (CVLT)
Time frame: visit n ° 2 (=between Day 22 and Day 27)
Continuous Performance Task (CPT-III)
Time frame: visit n ° 2 (=between Day22 and Day27)
Verbal Fluency Task
Time frame: visit n ° 2 (=between Day 22 and Day 27)
Test of Attention Assessment (TAP)
Time frame: visit n ° 2 (=between Day 22 and Day 27)
Montreal Cognitive Assessment (MoCA)
Time frame: visit n ° 2 (=between Day 22 and Day 27)
Results and safety
The study was stopped early (reason given: Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 28336492Schwitzer T, Schwan R, Bubl E, Lalanne L, Angioi-Duprez K, Laprevote V. Looking into the brain through the retinal ganglion cells in psychiatric disorders: A review of evidences. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jun 2;76:155-162. doi: 10.1016/j.pnpbp.2017.03.008. Epub 2017 Mar 20.
- Background: PubMed 32381369Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. Study of retinal structure and function in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature. J Fr Ophtalmol. 2020 May;43(5):e157-e166. doi: 10.1016/j.jfo.2020.04.004. Epub 2020 May 4.
- Background: PubMed 31443935Hebert M, Merette C, Gagne AM, Paccalet T, Moreau I, Lavoie J, Maziade M. The Electroretinogram May Differentiate Schizophrenia From Bipolar Disorder. Biol Psychiatry. 2020 Feb 1;87(3):263-270. doi: 10.1016/j.biopsych.2019.06.014. Epub 2019 Jun 27.
- Derived from this study: PubMed 36159928Gross G, Tursini K, Albuisson E, Angioi-Duprez K, Conart JB, Louis Dorr V, Schwan R, Schwitzer T. Bipolar disorders and retinal electrophysiological markers (BiMAR): Study protocol for a comparison of electroretinogram measurements between subjects with bipolar disorder and a healthy control group. Front Psychiatry. 2022 Sep 8;13:960512. doi: 10.3389/fpsyt.2022.960512. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Thomas SCHWITZER, MD, PhD principal investigator
Centre Psychothérapique de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG and ERG measurements (Retinaute®, BioSerenity), Actigraphy (Motion Watch 8®, CamNtech) and Neuropsychological assessments in people with Bipolar Disorder, run by Centre Psychothérapique de Nancy at 1 site 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 18 inclusion and 0 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.). 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?
Modification of amplitude measured with flash and pattern electroretinogram (time frame: Day 0 (=day of inclusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161546, which also lists 4 linked publications.
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 22 Aug 2024.