Major Depressive Disorder Clinical Trial
Official title:
Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder
Verified date | July 2017 |
Source | Ewha Womans University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Serious physical disease - Substance abuse or dependence history in recent 6 months - Pregnant or having plan to be pregnant |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Holy Family Hospital | Bucheon City | Kyunggi-Do |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Seoul St. Mary's Hospital | Seoul | |
Korea, Republic of | St. Paul's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Ewha Womans University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton depression rating scale | baseline, 1st, 2nd, 4th, 8th week | ||
Secondary | Clinical global impression scale | baseline, 1st, 2nd, 4th, 8th week | ||
Secondary | Side effects assessment: the interview and examination by the investigators | baseline, 1st, 2nd, 4th, 8th week | ||
Secondary | Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level | baseline, 8th week | ||
Secondary | Serum creatinine level | baseline, 2nd, 8th week | ||
Secondary | Brain MRI | baseline, 8th week | ||
Secondary | Montgomery-Asberg depression scale | baseline, 1st, 2nd, 4th, 8th week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |