Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Major Depressive Disorder, sponsored by University of Utah.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
17-item Hamilton Depression Rating Scale; Maximum Score 54. Minimum Score 0. Higher scores are correlated with more severe depression
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 |
What the finished NCT04504253 record still lists
NCT04504253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
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 NCT04504253's enrollment target sits among peer trials
18 250th of 282 higher than 30 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
-
Study to Assess the Safety and Effectiveness of NMRA-335140-501
RECRUITING · Phase 3
-
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
-
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder
RECRUITING · Phase 3
-
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
RECRUITING · Phase 3
-
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI