Major Depressive DisorderPhase 4NCT03202095
Creatine for Treatment of Depression Associated With Type 2 Diabetes
A Phase 4 study testing Creatine Monohydrate in people with Major Depressive Disorder, run by University of Utah at 1 site in United States.
Trial summary
The investigators hypothesize that the administration of a widely available, naturally occurring dietary supplement, creatine monohydrate, will reduce the severity of depression in individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 64 years, women only
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Creatine Monohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 10 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Current diagnosis of Major Depressive Disorder identified by the SCID-5-RV
- Current HAM-D score of > 16
- Current type 2 diabetes (as confirmed by clinical history and baseline glycosylated hemoglobin percentage (HgA1c) > 6.5.
- Diabetes type II present for at least one year
Who cannot join
- Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5-RV
- History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)
- Electrolyte disturbance (hypokalemia, hyperkalemia, hyponatremia, or hypernatremia) on screening basic metabolic panel
- History of cardiac disease or QTc >500ms on screening EKG
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
- History of seizure disorder
Show all 11Show fewer
- Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
- Positive pregnancy test
- Breastfeeding
- Contraindication to an MRI scan
- Current incarceration
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that the administration of a widely available, naturally occurring dietary supplement, creatine monohydrate, will reduce the severity of depression in individuals with type 2 diabetes. The purpose of this study is to determine whether 12 weeks of creatine supplementation is an effective treatment for depression in individuals with type 2 diabetes.
Read the detailed description
Depression is a debilitating illness associated with diminished quality of life and significant personal and societal costs. Depression is twice as common in those with type 2 diabetes compared to the general population. Antidepressants are commonly prescribed as treatment for depression; however, they may not be the optimal treatment for people with type 2 diabetes. Creatine has been shown to decrease symptoms of depression in many types of individuals when used over the course of 8 weeks or more. The purpose of this study is to investigate whether creatine can decrease symptoms of depression in individuals with type 2 diabetes when taken daily for 12 weeks. This study also investigates how creatine impacts brain chemistry as creatine decreases depressive symptoms.
- Conditions
- Major Depressive Disorder
- Being tested
- Creatine Monohydrate
- Keywords
- Depression, Type 2 Diabetes, Creatine, Diabetes
- Medical subject headings
- Depressive Disorder, Major, Depression, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDrug
5 grams daily of oral creatine monohydrate powder.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment with Creatine | Experimental | 5 grams daily of oral creatine monohydrate powde Receives: Drug: Creatine Monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hamilton Depression Rating Scale
The purpose of this study is to determine whether 12 weeks of dietary creatine augmentation with oral 5 g creatine daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Aug 2017
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Why it stopped: No referral from diabetes clinic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perry Renshaw, University of Utah
- Investigators
- Perry F Renshaw, MD, PhD, MBA, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202095
- Sponsor's protocol ID
- 00101803
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2017
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine for Treatment of Depression Associated With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03202095
- Acronym / sponsor ID
- 00101803
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Type 2 Diabetes, Creatine, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No referral from diabetes clinic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that the administration of a widely available, naturally occurring dietary supplement, creatine monohydrate, will reduce the severity of depression in individuals with type 2 diabetes. The purpose of this study is to determine whether 12 weeks of creatine supplementation is an effective treatment for depression in individuals with type 2 diabetes.
Detailed description
Depression is a debilitating illness associated with diminished quality of life and significant personal and societal costs. Depression is twice as common in those with type 2 diabetes compared to the general population. Antidepressants are commonly prescribed as treatment for depression; however, they may not be the optimal treatment for people with type 2 diabetes. Creatine has been shown to decrease symptoms of depression in many types of individuals when used over the course of 8 weeks or more. The purpose of this study is to investigate whether creatine can decrease symptoms of depression in individuals with type 2 diabetes when taken daily for 12 weeks. This study also investigates how creatine impacts brain chemistry as creatine decreases depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment with Creatine | Experimental | Drug: Creatine Monohydrate5 grams daily of oral creatine monohydrate powde |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current diagnosis of Major Depressive Disorder identified by the SCID-5-RV
- Current HAM-D score of > 16
- Current type 2 diabetes (as confirmed by clinical history and baseline glycosylated hemoglobin percentage (HgA1c) > 6.5.
- Diabetes type II present for at least one year
Key exclusion criteria (11 listed)
- Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5-RV
- History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)
- Electrolyte disturbance (hypokalemia, hyperkalemia, hyponatremia, or hypernatremia) on screening basic metabolic panel
- History of cardiac disease or QTc >500ms on screening EKG
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine Monohydrate5 grams daily of oral creatine monohydrate powder. | Drug | Open Label Treatment with Creatine |
Primary outcome
Change from Baseline in Hamilton Depression Rating Scale
Time frame: 12 weeks
The purpose of this study is to determine whether 12 weeks of dietary creatine augmentation with oral 5 g creatine daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perry F Renshaw, MD, PhD, MBA principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Creatine Monohydrate in people with Major Depressive Disorder, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hamilton Depression Rating Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.