Major Depressive DisorderNCT00729755
Creatine Augmentation Treatment in Major Depressive Disorder Subjects
A study testing Creatine monohydrate in people with Major Depressive Disorder, run by Ewha Womans University at 4 sites in South Korea.
Trial summary
Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its potential usefulness in improving brain energy metabolism, 3) the reported abnormality in brain energy metabolism in MDD subjects, and 4) plausible association between depression and inflammatory mediators, we hypothesize that… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Aug 2008to May 2012
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19-65 year-old male or female
- Major depressive disorder diagnosed by SCID-IV
- Hamilton depression rating scale score >= 16 at screening
- Written informed consent
Who cannot join
- Suicidal idea that needs hospitalization
- Any other axis I psychiatric disorder
- Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
- IQ below 80
- Inflammatory disease including autoimmune disease
- Taking anti-inflammatory medication
Show all 9Show fewer
- Serious physical disease
- Substance abuse or dependence history in recent 6 months
- Pregnant or having plan to be pregnant
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Holy Family Hospital
Bucheon-si, Gyeonggi-do
Seoul St. Mary's Hospital
Seoul, 137-701
Seoul National University Hospital
Seoul
St. Paul's Hospital
Seoul
About this study
Official title: Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder
Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its potential usefulness in improving brain energy metabolism, 3) the reported abnormality in brain energy metabolism in MDD subjects, and 4) plausible association between depression and inflammatory mediators, we hypothesize that oral Cr augmentation will help reduce symptoms in MDD patients as well as normalize a deficit in brain energy metabolism and that improvement of MDD and brain energy metabolism will be correlated with inflammatory mediators changes.
In this study, we plan to conduct an randomized, double-blind, placebo-controlled augmentation study with creatine in addition to escitalopram. We will assess the efficacy and safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and inflammatory mediators.
- Conditions
- Major Depressive Disorder
- Being tested
- Creatine monohydrate, Placebo
- Keywords
- Creatine, Augmentation, Major Depressive Disorder, Efficacy, Brain Energy Metabolism
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDietary supplement
In addition to 10-20mg escitalopram, the subjects will be given total 3 gram of creatine (500mg/capsule) a day in first week and then, 5 gram a day in the rest of the weeks.
PlaceboDietary supplement
In addition to 10-20mg escitalopram, the subjects will be given total 6 capsules of placebo (equal quantities to those of creatine group) a day in first week and then, 10 capsules a day in the rest of the weeks.
| Study group | Role | What they receive |
|---|---|---|
| Creatine | Experimental | The subjects with major depressive disorder, treated with creatine in addition to escitalopram Receives: Dietary Supplement: Creatine monohydrate |
| Placebo | Placebo comparator | The subjects with major depressive disorder, treated with placebo in addition to escitalopram Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton depression rating scale
Measured: baseline, 1st, 2nd, 4th, 8th week
Secondary outcomes (6)
Clinical global impression scale
Measured: baseline, 1st, 2nd, 4th, 8th week
Side effects assessment: the interview and examination by the investigators
Measured: baseline, 1st, 2nd, 4th, 8th week
Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level
Measured: baseline, 8th week
Serum creatinine level
Measured: baseline, 2nd, 8th week
Brain MRI
Measured: baseline, 8th week
Montgomery-Asberg depression scale
Measured: baseline, 1st, 2nd, 4th, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
- Investigators
- Perry F Renshaw, MD, PhD, Study chair, University of UtahIn Kyoon Lyoo, MD, PhD, MMS, Study director, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729755
- Sponsor's protocol ID
- BIC-08DE00101B
- Status last verified
- Jul 2017
- First submitted
- 4 Aug 2008
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoon S, Kim JE, Hwang J, Kim TS, Kang HJ, Namgung E, Ban S, Oh S, Yang J, Renshaw PF, Lyoo IK. Effects of Creatine Monohydrate Augmentation on Brain Metabolic and Network Outcome Measures in Women With Major Depressive Disorder. Biol Psychiatry. 2016 Sep 15;80(6):439-447. doi: 10.1016/j.biopsych.2015.11.027. Epub 2015 Dec 15.
PubMed 26822799Lyoo IK, Yoon S, Kim TS, Hwang J, Kim JE, Won W, Bae S, Renshaw PF. A randomized, double-blind placebo-controlled trial of oral creatine monohydrate augmentation for enhanced response to a selective serotonin reuptake inhibitor in women with major depressive disorder. Am J Psychiatry. 2012 Sep;169(9):937-945. doi: 10.1176/appi.ajp.2012.12010009.
PubMed 22864465
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00729755
- Acronym / sponsor ID
- BIC-08DE00101B
- Conditions
- Major Depressive Disorder
- Keywords
- Creatine, Augmentation, Major Depressive Disorder, Efficacy, Brain Energy Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Aug 2008 (estimated)
- 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.
Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its potential usefulness in improving brain energy metabolism, 3) the reported abnormality in brain energy metabolism in MDD subjects, and 4) plausible association between depression and inflammatory mediators, we hypothesize that oral Cr augmentation will help reduce symptoms in MDD patients as well as normalize a deficit in brain energy metabolism and that improvement of MDD and brain energy metabolism will be correlated with inflammatory mediators changes.
In this study, we plan to conduct an randomized, double-blind, placebo-controlled augmentation study with creatine in addition to escitalopram. We will assess the efficacy and safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and inflammatory mediators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine | Experimental | Dietary Supplement: Creatine monohydrateThe subjects with major depressive disorder, treated with creatine in addition to escitalopram |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe subjects with major depressive disorder, treated with placebo in addition to escitalopram |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19-65 year-old male or female
- Major depressive disorder diagnosed by SCID-IV
- Hamilton depression rating scale score >= 16 at screening
- Written informed consent
Key exclusion criteria (9 listed)
- Suicidal idea that needs hospitalization
- Any other axis I psychiatric disorder
- Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
- IQ below 80
- Inflammatory disease including autoimmune disease
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 monohydrateIn addition to 10-20mg escitalopram, the subjects will be given total 3 gram of creatine (500mg/capsule) a day in first week and then, 5 gram a day in the rest of the weeks. | Dietary supplement | Creatine |
| PlaceboIn addition to 10-20mg escitalopram, the subjects will be given total 6 capsules of placebo (equal quantities to those of creatine group) a day in first week and then, 10 capsules a day in the rest of the weeks. | Dietary supplement | Placebo |
Primary outcome
Hamilton depression rating scale
Time frame: baseline, 1st, 2nd, 4th, 8th week
6 secondary outcomes
Clinical global impression scale
Time frame: baseline, 1st, 2nd, 4th, 8th week
Side effects assessment: the interview and examination by the investigators
Time frame: baseline, 1st, 2nd, 4th, 8th week
Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level
Time frame: baseline, 8th week
Serum creatinine level
Time frame: baseline, 2nd, 8th week
Brain MRI
Time frame: baseline, 8th week
Montgomery-Asberg depression scale
Time frame: baseline, 1st, 2nd, 4th, 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Derived from this study: PubMed 26822799Yoon S, Kim JE, Hwang J, Kim TS, Kang HJ, Namgung E, Ban S, Oh S, Yang J, Renshaw PF, Lyoo IK. Effects of Creatine Monohydrate Augmentation on Brain Metabolic and Network Outcome Measures in Women With Major Depressive Disorder. Biol Psychiatry. 2016 Sep 15;80(6):439-447. doi: 10.1016/j.biopsych.2015.11.027. Epub 2015 Dec 15.
- Derived from this study: PubMed 22864465Lyoo IK, Yoon S, Kim TS, Hwang J, Kim JE, Won W, Bae S, Renshaw PF. A randomized, double-blind placebo-controlled trial of oral creatine monohydrate augmentation for enhanced response to a selective serotonin reuptake inhibitor in women with major depressive disorder. Am J Psychiatry. 2012 Sep;169(9):937-945. doi: 10.1176/appi.ajp.2012.12010009.
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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 study chair
University of Utah
In Kyoon Lyoo, MD, PhD, MMS study director
Ewha Womans University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine monohydrate in people with Major Depressive Disorder, run by Ewha Womans University at 4 sites in South Korea.
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 9 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: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hamilton depression rating scale (time frame: baseline, 1st, 2nd, 4th, 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729755, which also lists 2 linked publications.
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 5 Jul 2017.