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NCT04504253 · ClinicalTrials.gov registry record · Phase 3
A Pilot Study of Creatine Monohydrate as an Augmenting Agent for ECT in Persons With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by University of Utah.
- Completed
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04504253 is a Phase 3 study of Major Depressive Disorder that has completed, run by University of Utah. The registered enrollment target is 18 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04504253, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
We propose to determine if augmentation of electroconvulsive therapy (ECT) utilized for the treatment of major depressive disorder (MDD) with daily oral creatine will lead to an accelerated response to treatment, an overall increase in response rate, and will protect against cognitive adverse effects associated with ECT. We propose to conduct a two-arm, parallel, randomized, double-blinded, placebo-controlled trial, with a treatment group receiving 20 g oral loading dose of creatine for 1 week starting the day before initiating ECT, followed by 5 g oral creatine daily for roughly five weeks, including the approximately three-week ECT treatment course and a two-week follow-up period. Response to treatment will be assessed using the Quick Inventory of Depressive Symptomatology (QIDS) at each treatment and the 17-item Hamilton Depression Rating Scale (HAM-D17) at the end of each week.
Conditions Studied
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT Creatine monohydrate
Study Locations (1)
Utah
- University of Utah Department of Psychiatry - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2023-08-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04504253
The ClinicalTrials.gov registry entry for NCT04504253 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (95% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04504253 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT04504253 about?
NCT04504253 is a clinical study titled "A Pilot Study of Creatine Monohydrate as an Augmenting Agent for ECT in Persons With Major Depressive Disorder". We propose to determine if augmentation of electroconvulsive therapy (ECT) utilized for the treatment of major depressive disorder (MDD) with daily oral creatine will lead to an accelerated response to treatment, an overall increase in response rate, and will protect against cognitive adverse effect...
What is the current status of trial NCT04504253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2020-08-03. Estimated completion is 2023-08-02.
What conditions does trial NCT04504253 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04504253?
The interventions under investigation include: Placebo (DRUG), Creatine monohydrate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04504253?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04504253 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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