DELPhI Evaluation of Psychiatric Conditions

NCT03842345 | Withdrawn

• 1 other identifier: 605
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Major Depressive Disorder; Bi-Polar Disorder; ADHD; Schizophrenia; OCD; Ptsd; Healthy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• correlation between DELPhI parameters and symptom severity.

  through study completion, an average of 1 year

• Cluster analysis of Plasticity and connectivity in relation to medical treatment and clinical diagnosis.

  through study completion, an average of 1 year.

• characterization of the change in Plasticity following change of treatment regimen

  through study completion, an average of 1 year.

• characterization of the change in Connectivity following change of treatment regimen

  through study completion, an average of 1 year.

Study Arms (2)

Psychiatric patients

Major depression, Bi-polar, schizophrenia, ADHD, OCD, PTSD

healthy controls

young healthy controls to serve as norm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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..
• A normal neurological exam- control group.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• QuantalX Neuroscience: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity; Schizophrenia; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 3, 2022

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share