To assess utility and accuracy of an electroencephalography (EEG) -based brain network analysis platform as potential diagnostic tool for MDD, to correlate digital biomarkers and *gold standard* psychometric questionnaires such as MADRS in MDD and…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mini International Neuropsychiatric Interview (MINI)
Structured Interview for the Hamilton Rating Scale for Depression (SIGHD-IDS)
Montgomery-Åsberg Depression Rating Scale Structured Interview Guide
(MADRS-SIGMA)
Quick Inventory of Depressive Symptomatology (QIDS-SR) self-reportversion
Columbia Suicide Severity Rating Scale (C-SSRS).
Depression Stress Scales (DASS)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
ElMindA Cognitive Tests (Brain Network Activation)
Cambridge Cognition, CognitionKit (cognition and mood assessments)
Sonde Health (voice sampling procedure, vocal analytics)
NeuroCart (Neuropsychological Test Battery)
BeHapp (social interactions)
Neurotrack (eye movement)
Emotional Bias Task (EBT)
F1l
Secondary outcome
Exploratory (fluid) Biomarkers :
Metabolic, inflammatory, and disease state markers including but not limited to
the following: BDNF, D-serine, IL-6, CRP, TNF-alpha, IFN-gamma, IL- 1beta,
IL-1Ra, IL-4, IL-13 and Tryptophan/kynurenine pathway metabolites. Exploratory
genetic markers including but not limited to polymorphisms associated with
disease may also be examined.
Background summary
Since the introduction of antidepressants to psychiatry in the 1960s, the
Hamilton Depression Rating Scale (HAMD) and the Montgomery & Äsberg Depression
Rating Scale (MADRS) have been the most frequently used rating scales to assess
patient outcome in major depressive disorder (MDD). As a result, they are
considered the *clinical gold standard* to assess pharmacodynamic effects in
MDD drug trials. However, both scales are associated with methodological
limitations such as unintended therapeutic effects when administered by
researchers, over-predicting therapeutic effects in research settings compared
to naturalistic settings and concerns about sensitivity to the effects of novel
nonmonoaminergic
compounds. The development of novel and potentially more effective
antidepressant drugs is therefore hampered by the lack of reliable objective
biomarkers and the excessive reliance on clinic-based psychometric
questionnaires to quantify drug effects. Taken together, there is a need to
identify, validate and implement more sophisticated and methodologically sound
technologies to quantify pharmacodynamic effects of novel CNS penetrating
compounds in patients with MDD.
Study objective
To assess utility and accuracy of an electroencephalography (EEG) -based brain
network analysis platform as potential diagnostic tool for MDD, to correlate
digital biomarkers and *gold standard* psychometric questionnaires such as
MADRS in MDD and to identify digital biomarkers that are potentially predictive
of MDD diagnosis.
Furthermore, we will explore whether there are any differences between healthy
volunteers and MDD patients with regard to exploratory soluble biomarkers
including but not limited to inflammatory, metabolic, and disease state markers
and will conduct exploratory genetic analyses including but not limited to
polymorphisms associated with MDD disease state.
Study design
The study will be a cross-sectional, non-interventional study.
Study burden and risks
There is no benefit expected for subjects participating in this study and no or
minimal risk (blood withdrawals) is anticipated. MDD patients will be carefully
evaluated to assess whether it would be desirable and safe for them for
participate. Hopefully this study will help develop new objective methods to
test novel and potentially more effective antidepressant drugs which are now
being hampered by the lack of reliable objective biomarkers and the excessive
reliance on clinic-based psychometric questionnaires to quantify drug effects.
Lichtstrasse 35 0
Basel 4056
CH
Lichtstrasse 35 0
Basel 4056
CH
Listed location countries
Age
Inclusion criteria
Patients:
1. Written informed consent must be obtained before any assessment is performed.
2. Males and females, age 18 to 65 years (inclusive).
3. Subjects must be diagnosed by the attending general practitioner,
psychiatrist or clinical psychologist with, and meet the diagnostic criteria
for at least one of the following disorders as confirmed with the Mini
International Neuropsychiatric Interview (MINI):
4. Current major depressive disorder (MDD) without psychotic features according
to DSM-5 (296.22, 296.23, 296.32, 296.33).
5. Current persistent depressive disorder (PDD) or dysthymia according to the
DSM-5 (300.4).
6. Total HAMD-17 total score of >16 at Screening.
7. Use of mono-aminergic antidepressant drug (SSRI, SNRI, mirtazapine, TCA,
MAO-I) at a stable dose for at least 4 weeks (6 weeks for fluoxetine).
8. Must read and speak both Dutch and English as a first or second language.
9. Subjects must own and use a personal computer (desktop or laptop) using the
Windows operating system
10. Able to comply with the study procedures, prohibitions and restrictions
(drug and alcohol use) as specified in the protocol.
11. Android-based smartphone , Healty volunteers :
1. Written informed consent must be obtained before any assessment is performed.
2. Male or female subjects, 18 to 65 years (inclusive)
3. Body mass index (BMI) between 18 and 30 kg/m2.
4. Must read and speak both Dutch and English as a first or second language.
5.Subjects must own and use a personal computer (desktop or laptop) using the
Windows
operating system.
6. Able to comply with the study procedures, prohibitions and restrictions (drug
and alcohol use) as specified in the protocol.
7. Android-based smartphone
Exclusion criteria
Patients:
1. Current primary DSM-5 diagnosis of general anxiety disorder (GAD), panic
disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder
(PTSD), anorexia nervosa, bulimia nervosa or cluster C personality disorder
(e.g. avoidant, dependent, obsessive-compulsive personality disorders).
Subjects for whom the diagnosed mood disorder (MDD, PDD or
dysthymia) is considered the primary diagnosis are not excluded.
2. Current or previously diagnosed psychotic disorder, mood disorder with
psychotic features, bipolar disorder, mental retardation, cluster B personality
disorder (e.g., borderline, antisocial, narcissistic personality disorders).
3. Current or recent history of clinically significant suicidal thoughts or
ideation within the past 12 months or any suicidal behavior within the past 6
months as demonstrated with the C-SSRS should be carefully screened and only
included at the discretion of the investigator.
4. Positive urine test for drugs of abuse at Screening or on study days or a
current diagnosis of substance use disorder (including alcohol but excluding
nicotine), or previous substance use disorder (including alcohol but excluding
nicotine) within the past 12 months according to DSM-5.
5. Evidence of renal, hepatic, cardiovascular or metabolic dysfunction or any
active or chronic disease or condition that could interfere with the conduct of
the study, or that would pose an unacceptable risk to the subject in the
opinion of the investigator (following a detailed medical history, physical
examination, vital signs (systolic and diastolic blood pressure, pulse rate,
body temperature) and12-lead electrocardiogram (ECG)). Minor deviations from
the normal range may be accepted, if judged by the investigator to have no
clinical relevance.
6. Clinically significant abnormalities, as judged by the investigator, in
laboratory test results (including hepatic and renal panels, complete blood
count, chemistry panel and urinalysis). In the case of uncertain or
questionable results, tests performed during Screening may be repeated
before randomization to confirm eligibility or to assist in evaluating clinical
relevance.
7. Clinically significant abnormalities, as judged by the investigator, in
laboratory test results (including hepatic and renal panels, complete blood
count, chemistry panel and urinalysis). In the case of uncertain or
questionable results, tests performed during Screening may be repeated to
confirm eligibility or to assist in evaluating clinical relevance.
8. Positive urine *-human chorionic gonadotropin (*-hCG) pregnancy test at
Screening in women of childbearing potential.
9. Current enrollment in an interventional study., Healthy volunteers:
1. Current or previous clinically relevant history or family history of
psychiatric disorders, neurological disorders or neurosurgery.
2. Positive urine test for drugs of abuse at Screening or on study days or a
current diagnosis of substance use disorder (including alcohol but excluding
nicotine) or previous substance use disorder (including alcohol but excluding
nicotine) within the past 12 months according to DSM-5.
3. Evidence of renal, hepatic, cardiovascular or metabolic dysfunction or any
active or chronic disease or condition that could interfere with the conduct of
the study, or that would pose an unacceptable risk to the subject in the
opinion of the investigator (following a detailed medical history, physical
examination, vital signs (systolic and diastolic blood pressure, pulse rate,
body temperature) and12-lead electrocardiogram (ECG)). Minor deviations from
the normal range may be accepted, if judged by the investigator to have no
clinical relevance.
4. Clinically significant abnormalities, as judged by the investigator, in
laboratory test results (including hepatic and renal panels, complete blood
count, chemistry panel and urinalysis). In the case of uncertain or
questionable results, tests performed during Screening may be repeated
before randomization to confirm eligibility or judged to be clinically
irrelevant for healthy subjects.
5. Use of any medications (prescription or over-the-counter [OTC]), within 14
days of Visit 1, or less than 5 half-lives (whichever is longer). An exception
is paracetamol (up to 2 g/day). Other exceptions will only be made if the
rationale is clearly documented by the investigator.
6. Positive urine *-human chorionic gonadotropin (*-hCG) pregnancy test at
Screening in women of childbearing potential.
7. Current enrollment in an interventional study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL64192.056.18 |