Major Depressive DisorderNCT03842345
DELPhI Evaluation of Psychiatric Conditions
An observational study of Major Depressive Disorder and Bi-Polar Disorder, run by QuantalX Neuroscience.
Trial summary
DELPhI acquisition and analysis software, a QuantalX Neuroscience development, which is designed to measure, analyze, and display brain electrical activity of human electroencephalogram (EEG), to transcranial magnetic stimulation (TMS), will be used to evaluate different psychiatric conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Bi-Polar Disorder, ADHD
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Feb 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: study group: patients diagnosed with either Major depression, Bi-polar disorder, OCD, PTSD, ADHD or Schizophrenia,.without any psychiatric medications or with stable treatment regimen for the last 2 months. Control group: Eligible consecutive healthy individuals, recruited through advertisements spread in campuses and clinics.
Who may be able to join
- Adult male and female patients between the age of 18-80 years old.
- Patients willing to participate with all of the study procedures and sign informed consent form.
- A clinical diagnosis of psychiatric condition that requires medication or other intervention (such as brain stimulation or psychological treatment).-study groups.
- Without any psychiatric medications or with stable treatment regimen for the last 2 months-study groups..
- 4.5. A normal neurological exam- control group.
Who cannot join
- 1. Prior known epileptic episode. 2. History of any neurodegenerative disease. 3. Patients with history of other known brain disorder/pathology. 4. Contraindication to MR imaging.
- -
About this study
Official title: Cross-sectional Evaluation of Psychiatric Population With DELPhI- Characterization of Psychiatric Conditions
DELPhI acquisition and analysis software, a QuantalX Neuroscience development, which is designed to measure, analyze, and display brain electrical activity of human electroencephalogram (EEG), to transcranial magnetic stimulation (TMS), will be used to evaluate different psychiatric conditions.
Read the detailed description
Psychiatric conditions requiring pharmaceutical treatment include Schizophrenia and other psychotic disorders, Major depressive disorder, Bi-polar disorder, Post Traumatic Stress Disorder, Obsessive Compulsive Disorder and anxiety disorders. To date none of the psychiatric conditions mentioned diagnosis' relies on an imaging or other quantitative technique. Diagnosis and treatment prescription in the psychiatric clinic still relies on subjective reports and physician assessment of symptoms. Trans-cranial magnetic stimulation (TMS) is a noninvasive brain stimulation method that allows to study human cortical function In-vivo. Using TMS for examining human cortical functionality is enhanced by combining TMS with simultaneous registration of electroencephalograph (EEG). EEG provides an opportunity to directly measure the cerebral response to TMS, measuring the cortical TMS Evoked potential (TEP), is used to assess cerebral reactivity across wide areas of neo-cortex. Studies integrating TMS with EEG (TMS-EEG) have shown that TMS produces waves of activity that reverberate throughout the cortex. and that are reproducible and reliable thus providing direct information about cortical excitability and connectivity with excellent time resolution. By evaluating the propagation of evoked activity in different behavioral states and in different tasks, TMS-EEG has been used to causally probe the dynamic effective connectivity of human brain networks.
- Conditions
- Major Depressive Disorder, Bi-Polar Disorder, ADHD, Schizophrenia, OCD, Ptsd
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Attention Deficit Disorder with Hyperactivity, Schizophrenia, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psychiatric patients | Major depression, Bi-polar, schizophrenia, ADHD, OCD, PTSD | |
| healthy controls | young healthy controls to serve as norm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms.
Comparison of DELPhI parameters of Plasticity in patients, in comparison to healthy norms. Parameters will be analyzed for their temporal and special components.
Measured: through study completion, an average of 1 year
comparison of DELPhI parameter of Connectivity in psychiatric population to healthy norms.
Comparison of DELPhI parameters of Connectivity in patients, in comparison to healthy norms. Parameters will be analyzed for their temporal and special components.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
correlation between DELPhI parameters and symptom severity.
Self-control analysis of the change in DELPhI parameters following change in treatment prescription or any other treatment at different time points compared to base-line. Correlation to symptom severity will be assessed.
Measured: through study completion, an average of 1 year
Cluster analysis of Plasticity and connectivity in relation to medical treatment and clinical diagnosis.
Cluster subjects by each plasticity and connectivity vs. medical treatment and clinical diagnosis.
Measured: through study completion, an average of 1 year.
characterization of the change in Plasticity following change of treatment regimen
characterization of the change in Plasticity of Plasticity following change of treatment regimen.
Measured: through study completion, an average of 1 year.
characterization of the change in Connectivity following change of treatment regimen
characterization of the change in Connectivity following change of treatment regimen.
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startMar 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: Study was withdrawn due to recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- QuantalX Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842345
- Sponsor's protocol ID
- 605
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 3 Mar 2022
- 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 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Evaluation of Psychiatric Population With DELPhI- Characterization of Psychiatric Conditions
- ClinicalTrials.gov ID
- NCT03842345
- Acronym / sponsor ID
- 605
- Conditions
- Major Depressive Disorder, Bi-Polar Disorder, ADHD, Schizophrenia, OCD, Ptsd
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn due to recruitment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- QuantalX NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- Mar 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 15 Feb 2019 (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.
DELPhI acquisition and analysis software, a QuantalX Neuroscience development, which is designed to measure, analyze, and display brain electrical activity of human electroencephalogram (EEG), to transcranial magnetic stimulation (TMS), will be used to evaluate different psychiatric conditions.
Detailed description
Psychiatric conditions requiring pharmaceutical treatment include Schizophrenia and other psychotic disorders, Major depressive disorder, Bi-polar disorder, Post Traumatic Stress Disorder, Obsessive Compulsive Disorder and anxiety disorders. To date none of the psychiatric conditions mentioned diagnosis' relies on an imaging or other quantitative technique. Diagnosis and treatment prescription in the psychiatric clinic still relies on subjective reports and physician assessment of symptoms. Trans-cranial magnetic stimulation (TMS) is a noninvasive brain stimulation method that allows to study human cortical function In-vivo. Using TMS for examining human cortical functionality is enhanced by combining TMS with simultaneous registration of electroencephalograph (EEG). EEG provides an opportunity to directly measure the cerebral response to TMS, measuring the cortical TMS Evoked potential (TEP), is used to assess cerebral reactivity across wide areas of neo-cortex. Studies integrating TMS with EEG (TMS-EEG) have shown that TMS produces waves of activity that reverberate throughout the cortex. and that are reproducible and reliable thus providing direct information about cortical excitability and connectivity with excellent time resolution. By evaluating the propagation of evoked activity in different behavioral states and in different tasks, TMS-EEG has been used to causally probe the dynamic effective connectivity of human brain networks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychiatric patients | – | –Major depression, Bi-polar, schizophrenia, ADHD, OCD, PTSD |
| healthy controls | – | –young healthy controls to serve as norm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- study group: patients diagnosed with either Major depression, Bi-polar disorder, OCD, PTSD, ADHD or Schizophrenia,.without any psychiatric medications or with stable treatment regimen for the last 2 months. Control group: Eligible consecutive healthy individuals, recruited through advertisements spread in campuses and clinics.
Key inclusion criteria (5 listed)
- Adult male and female patients between the age of 18-80 years old.
- Patients willing to participate with all of the study procedures and sign informed consent form.
- A clinical diagnosis of psychiatric condition that requires medication or other intervention (such as brain stimulation or psychological treatment).-study groups.
- Without any psychiatric medications or with stable treatment regimen for the last 2 months-study groups..
- 4.5. A normal neurological exam- control group.
Key exclusion criteria (2 listed)
- 1. Prior known epileptic episode. 2. History of any neurodegenerative disease. 3. Patients with history of other known brain disorder/pathology. 4. Contraindication to MR imaging.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms.
Time frame: through study completion, an average of 1 year
Comparison of DELPhI parameters of Plasticity in patients, in comparison to healthy norms. Parameters will be analyzed for their temporal and special components.
comparison of DELPhI parameter of Connectivity in psychiatric population to healthy norms.
Time frame: through study completion, an average of 1 year
Comparison of DELPhI parameters of Connectivity in patients, in comparison to healthy norms. Parameters will be analyzed for their temporal and special components.
4 secondary outcomes
correlation between DELPhI parameters and symptom severity.
Time frame: through study completion, an average of 1 year
Cluster analysis of Plasticity and connectivity in relation to medical treatment and clinical diagnosis.
Time frame: through study completion, an average of 1 year.
characterization of the change in Plasticity following change of treatment regimen
Time frame: through study completion, an average of 1 year.
characterization of the change in Connectivity following change of treatment regimen
Time frame: through study completion, an average of 1 year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Bi-Polar Disorder, run by QuantalX Neuroscience.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms. (time frame: through study completion, an average of 1 year). 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?
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 3 Mar 2022.