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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: Recruiting study of Major Depressive Disorder and Bipolar Disorder, sponsored by Mark Niciu.
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. According to ClinicalTrials.gov, the official US trial registry.
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").
Primary Outcome
For patients with TRD, the MADRS will be administered. The MADRS contains 10 items, and each item is scored 0-6. These item scores are summed to create a scale score; thus, scale scores range from 0 to 60. A scale score of 0 indicates the absence of depressive symptoms, while a score of 60 indicates severe depression. The primary outcome is the mean change in total MADRS score. A decrease in the mean MADRS score indicates a decrease (or improvement) in depressive symptoms, whereas an increase in
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2050-08 |
What NCT04480918 shows while recruiting
NCT04480918 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 373-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (168% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04480918's enrollment target sits among peer trials
1,000 7th of 282 higher than 274 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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