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NCT04480918 · ClinicalTrials.gov registry record

University of Iowa Interventional Psychiatry Service Patient Registry

A clinical trial of Major Depressive Disorder and Bipolar Disorder, sponsored by Mark Niciu.

Recruiting
Registry status
1,000
Enrollment target
1
Study location

NCT04480918 is a study of Major Depressive Disorder and Bipolar Disorder that is actively recruiting participants, run by Mark Niciu. The registered enrollment target is 1,000 participants, above the 373-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (168% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04480918, a study of Major Depressive Disorder and Bipolar Disorder, is actively recruiting participants, sponsored by Mark Niciu.

RECRUITING
Registry status
1,000 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to examine the effects of interventional/procedural therapies for treatment-resistant depression (TRD) and Obsessive-Compulsive Disorder (OCD). These treatments include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), racemic ketamine infusion and intranasal esketamine insufflation. The investigators will obtain various indicators, or biomarkers, of a depressed individuals' state before, during, and/or after these treatments. Such biomarkers include neurobehavioral testing, neuroimaging, electroencephalography, cognitive testing, vocal recordings, epi/genetic testing, and autonomic nervous system measures (i.e. "fight-or-flight" response). The results obtained from this study may provide novel antidepressant treatment response biomarkers, with the future goal of targeting a given treatment to an individual patient ("personalized medicine").

Interventions

  • DRUG Ketamine
  • DEVICE Transcranial Magnetic Stimulation (TMS)
  • DEVICE Electroconvulsive Therapy (ECT)
  • DRUG Esketamine
  • DEVICE Deep Transcranial Magnetic Stimulation (dTMS)

Study Locations (1)

Iowa

  • University of Iowa Health Care - Iowa City

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2020-11-02
Est. Completion 2050-08

Sponsor

Mark Niciu

2 total trials

What the Registry Record Tells You About NCT04480918

The ClinicalTrials.gov registry entry for NCT04480918 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 373-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (168% higher). The listed sponsor is Mark Niciu, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 5 interventions - of which Ketamine is the first listed.

NCT04480918 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.

Frequently Asked Questions

What is clinical trial NCT04480918 about?

NCT04480918 is a clinical study titled "University of Iowa Interventional Psychiatry Service Patient Registry". The purpose of this study is to examine the effects of interventional/procedural therapies for treatment-resistant depression (TRD) and Obsessive-Compulsive Disorder (OCD). These treatments include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), racemic ketamine infusion an...

What is the current status of trial NCT04480918?

This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2020-11-02. Estimated completion is 2050-08.

What conditions does trial NCT04480918 study?

This clinical trial studies the following conditions: Major Depressive Disorder, Bipolar Disorder, Obsessive - Compulsive Disorder, Treatment-Resistant Depression, Bipolar Depression.

What interventions are being tested in trial NCT04480918?

The interventions under investigation include: Ketamine (DRUG), Transcranial Magnetic Stimulation (TMS) (DEVICE), Electroconvulsive Therapy (ECT) (DEVICE), Esketamine (DRUG), Deep Transcranial Magnetic Stimulation (dTMS) (DEVICE).

Who is sponsoring clinical trial NCT04480918?

This trial is sponsored by Mark Niciu, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04480918 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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