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A Pilot Study of Creatine Monohydrate as an Augmenting Agent for ECT in Persons With Major Depressive Disorder

Phase 3
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Pivotal Trial

Summary

This trial tests whether adding creatine to electroconvulsive therapy (ECT) can improve treatment outcomes for patients with major depressive disorder (MDD). Creatine is a natural substance that boosts brain energy and may help ECT work better and faster. The study focuses on patients who haven't responded to other treatments. Creatine has shown beneficial effects in previous studies for patients with major depression, particularly those who have not responded to other treatments.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HAMD-17
Secondary study objectives
QIDS

Side effects data

From 2015 Phase 4 trial • 14 Patients • NCT01514630
71%
Cold and flu symptoms
29%
Diarrhea
21%
Stomach Discomfort
14%
Muscle Cramps
7%
Lightheaded
7%
Indigestion
7%
Polydipsia
7%
Headache
7%
Swelling in Hands
7%
Numbness and Tingling in hands
7%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creatine Monohydrate

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Creatine monohydrateExperimental Treatment1 Intervention
1. Week 1: Creatine monohydrate 5g PO QID 2. Week 2 up to Week 6: Creatine monohydrate 5g PO qday
Group II: PlaceboPlacebo Group1 Intervention
1. Week 1: Placebo 5g PO QID 2. Week 2 up to Week 6: Placebo 5g PO qday
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Creatine monohydrate
2005
Completed Phase 4
~670

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,146 Previous Clinical Trials
1,699,006 Total Patients Enrolled
22 Trials studying Depression
2,309 Patients Enrolled for Depression
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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