Trial Outcomes & Findings for A Pilot Study of Creatine Monohydrate as an Augmenting Agent for ECT in Persons With Major Depressive Disorder (NCT NCT04504253)

NCT ID: NCT04504253

Last Updated: 2024-11-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 18 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-11-26

Participant Flow

Participant milestones

Measure	Creatine Monohydrate 1. Week 1: Creatine monohydrate 5g PO QID 2. Week 2 up to Week 6: Creatine monohydrate 5g PO qday Creatine monohydrate: Creatine monohydrate loose powder	Placebo 1. Week 1: Placebo 5g PO QID 2. Week 2 up to Week 6: Placebo 5g PO qday Placebo: Placebo control (dextrose 5mg) matched to creatine monohydrate loose powder
Overall Study STARTED	9	9
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Creatine Monohydrate n=9 Participants 1. Week 1: Creatine monohydrate 5g PO QID 2. Week 2 up to Week 6: Creatine monohydrate 5g PO qday Creatine monohydrate: Creatine monohydrate loose powder	Placebo n=9 Participants 1. Week 1: Placebo 5g PO QID 2. Week 2 up to Week 6: Placebo 5g PO qday Placebo: Placebo control (dextrose 5mg) matched to creatine monohydrate loose powder	Total n=18 Participants Total of all reporting groups
Age, Continuous	36.9 years STANDARD_DEVIATION 12.9 • n=5 Participants	42.3 years STANDARD_DEVIATION 11.8 • n=7 Participants	39.6 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

Outcome measures

Measure	Creatine Monohydrate n=6 Participants 1. Week 1: Creatine monohydrate 5g PO QID 2. Week 2 up to Week 6: Creatine monohydrate 5g PO qday Creatine monohydrate: Creatine monohydrate loose powder	Placebo n=6 Participants 1. Week 1: Placebo 5g PO QID 2. Week 2 up to Week 6: Placebo 5g PO qday Placebo: Placebo control (dextrose 5mg) matched to creatine monohydrate loose powder
HAMD-17	16.4 score on a scale Standard Deviation 4.2	16.2 score on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: 6 weeks

Quick Inventory of Depressive Symptoms; Scores range from 0 to 27. Higher scores are correlated with more severe depression.

Outcome measures

Measure	Creatine Monohydrate n=6 Participants 1. Week 1: Creatine monohydrate 5g PO QID 2. Week 2 up to Week 6: Creatine monohydrate 5g PO qday Creatine monohydrate: Creatine monohydrate loose powder	Placebo n=6 Participants 1. Week 1: Placebo 5g PO QID 2. Week 2 up to Week 6: Placebo 5g PO qday Placebo: Placebo control (dextrose 5mg) matched to creatine monohydrate loose powder
QIDS	13.0 score on a scale Standard Deviation 5.1	13.4 score on a scale Standard Deviation 6.3

Adverse Events

Creatine Monohydrate

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Creatine Monohydrate n=9 participants at risk 1. Week 1: Creatine monohydrate 5g PO QID 2. Week 2 up to Week 6: Creatine monohydrate 5g PO qday Creatine monohydrate: Creatine monohydrate loose powder	Placebo n=9 participants at risk 1. Week 1: Placebo 5g PO QID 2. Week 2 up to Week 6: Placebo 5g PO qday Placebo: Placebo control (dextrose 5mg) matched to creatine monohydrate loose powder
Nervous system disorders Delirium	11.1% 1/9 • Number of events 1 • During six weeks of study participation. Standard definitions used.	0.00% 0/9 • During six weeks of study participation. Standard definitions used.
Vascular disorders Vertebral artery dissection	0.00% 0/9 • During six weeks of study participation. Standard definitions used.	11.1% 1/9 • Number of events 1 • During six weeks of study participation. Standard definitions used.

Other adverse events

Measure	Creatine Monohydrate n=9 participants at risk 1. Week 1: Creatine monohydrate 5g PO QID 2. Week 2 up to Week 6: Creatine monohydrate 5g PO qday Creatine monohydrate: Creatine monohydrate loose powder	Placebo n=9 participants at risk 1. Week 1: Placebo 5g PO QID 2. Week 2 up to Week 6: Placebo 5g PO qday Placebo: Placebo control (dextrose 5mg) matched to creatine monohydrate loose powder
Gastrointestinal disorders GI Distress	77.8% 7/9 • Number of events 10 • During six weeks of study participation. Standard definitions used.	33.3% 3/9 • Number of events 4 • During six weeks of study participation. Standard definitions used.
Skin and subcutaneous tissue disorders Rash	11.1% 1/9 • Number of events 1 • During six weeks of study participation. Standard definitions used.	0.00% 0/9 • During six weeks of study participation. Standard definitions used.

Additional Information

Brent Kious, MD

University of Utah

Phone: 8015851418

Email: brent.kious@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place