Major Depressive Disorder Clinical Trial
Official title:
Exploring Potential Serum/Plasma-Based Biomarkers as a Test for Major Depressive Disorder Diagnostics ("Bio-Test MDD")
The purpose of this study is to develop a blood test for major depression and measure the
effects of ziprasidone monotherapy on these markers.
Specific Aim: Using a multiplex biomarker assay we will measure levels of 16 biomarkers in
patients with MDD enrolled in this ancillary study (adjunct to study NCT00555997) and
compare these results to those of healthy controls" (defined as research subjects who have
not met criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.
This proposed study will be an ancillary study to clinical trial NCT00555997
(www.clinicaltrials.gov) entitled: "A 12-Week, Randomized, Double-Blind, Placebo-Controlled,
Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder"
(MDD)." Precision Human Biolaboratory ("PHB") is attempting to develop a proprietary blood
test intended to potentially serve as a biological marker ("bio-marker") for MDD.
Specifically, PHB's research team will employ a unique approach towards developing a
diagnostic test for MDD: measures from multiple blood-based biological markers will be
obtained from patients with MDD and then analyzed with the use of several interrelated
algorithms in order to derive a single biological measure ("bio-marker") with a high
predictive value for MDD. PHBs' test panel of blood-based biological markers will consist of
a number of cytokines, stress related hormones, and binding proteins that have each been
linked to MDD. This innovative test panel is expected to provide general practice physicians
with a tool to more accurately identify and classify patients with MDD which, in turn, could
potentially , allow for the more effective monitoring of pharmacotherapy (antidepressant
drug therapy). Thus, the development of a highly reliable biomarker for MDD could improve
the standard of care for depression.
For this ancillary study, 120 antidepressant-free outpatients with MDD who have been deemed
eligible to participate in trial NCT00555997 will be recruited from participating centers.
Participating subjects will undergo a blood draw during the baseline visit for NCT00555997.
Values obtained will be compared with those of "healthy controls" (defined as research
subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)) from an
existing dataset at PHB.
;
Observational Model: Case Control, Time Perspective: Prospective
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 |