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

NCT04504253 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IRB_00129040
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• HAMD-17

  17-item Hamilton Depression Rating Scale; Maximum Score 54. Minimum Score 0. Higher scores are correlated with more severe depression

  6 weeks

Secondary Outcomes (1)

• QIDS

  6 weeks

Study Arms (2)

Creatine monohydrate

EXPERIMENTAL

1. Week 1: Creatine monohydrate 5g PO QID 2. Week 2 up to Week 6: Creatine monohydrate 5g PO qday

Dietary Supplement: Creatine monohydrate

Placebo

PLACEBO COMPARATOR

1. Week 1: Placebo 5g PO QID 2. Week 2 up to Week 6: Placebo 5g PO qday

Drug: Placebo

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

Creatine monohydrate loose powder

Creatine monohydrate

Placebo DRUG

Placebo control (dextrose 5mg) matched to creatine monohydrate loose powder

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a diagnosis of Major Depressive Disorder with moderate to severe symptoms will be randomly assigned in a 1:1 ratio to either ECT with creatine augmentation or ECT with placebo augmentation or 6 weeks. Individuals must meet criteria for major depressive episode for a duration of at least 2 months in order to participate. Participants must be greater than 18 years of age and considered to be a good candidate for ECT based on clinical assessment. Individuals who are pregnant or breast-feeding or who possess any other contraindication to ECT will not be invited to participate. Participants can receive ECT treatments in either inpatient or outpatient setting at the University Neuropsychiatric Institute.

You may not qualify if:

• Individuals who meet diagnostic criteria for other psychiatric conditions apart from major depressive disorder (including Bipolar I, Bipolar II, or personality disorders) will not be invited to participate. Individuals with substance use disorders will be excluded because substance use disorders typically confound the diagnosis of depression and can contribute to treatment resistance. Individuals will not be considered for study participation if they have renal disease because to date it cannot definitively be stated if short and long-term creatine usage is or is not harmful to the kidneys. Appropriate renal function will be determined based on normal creatinine clearance, determined by routine laboratory work (basic metabolic panel).
• Participants who are already undergoing electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) for the treatment of depression, or who have completed a course of ECT within a month of the baseline visit, will not be invited to participate given the possibility of confounding treatment effects as well as increased seizure risk. Individuals currently undergoing psychotherapy remain eligible to participate.
• Participants who have implanted ferromagnetic hardware, implanted electronic devices, or retained ferromagnetic materials from surgery or injuries will not be invited to participate as these represent contraindications to MRI. Likewise, individuals who are unable to tolerate confinement in the MRI scanner will not be invited to participate.
• Individuals who lack capacity to consent to treatment or to participate in the study will be excluded. Patients who are hospitalized involuntarily will also be excluded. Individuals demonstrating active psychosis or any other clinical characteristic making them inappropriate candidates for treatment will be excluded. Patients with pre-existing neurologic condition, any major neurocognitive disorder, or known traumatic brain injury will not be invited to participate.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Department of Psychiatry

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Creatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Brent Kious, MD
• Organization: University of Utah

brent.kious@hsc.utah.edu

8015851418

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, double-blind, placebo-controlled. Block randomization protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Psychiatry

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: August 3, 2020
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)