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Creatine monohydrate for Depression
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 3-6 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 weeks
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 • NCT0151463071%
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
1,138 Previous Clinical Trials
1,791,650 Total Patients Enrolled
22 Trials studying Depression
2,309 Patients Enrolled for Depression
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