This clinical study is a randomized, double-blind, placebo-controlled trial with an intervention period of 4 weeks. Participants will be patients with moderate to severe depression who meet the inclusion criteria during the screening period. After recruitment written informed consent form will be signed and the baseline evaluation will be done then the treatment period follows. The subjects will be randomly assigned to a control group (escitalopram plus normal saline(NA)) and an ATP group (escitalopram plus adenosine disodium triphosphate(ATP)) in a 1:1 ratio for treatment, with a total number of 120 recruited patients. Assessment will be carried out as an analysis of changes in Hamilton Depression Scale(HAMD-24), cognitive function test, brain functional network, inflammatory markers, and other indicators in the first, second, and fourth week of intervention which will evaluate the effectiveness of ATP in improving moderate to severe depression preliminarily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.
Cap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGHAMD-24
Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome.
Time frame: Baseline, two weeks, and four weeks
Diffusion Tensor Imaging
Diffusion Tensor Imaging(DTI) is used to detect changes in fractional anisotropy (FA) maps of brain white matter fiber in major depressive patients.
Time frame: Baseline, two weeks, and four weeks
Diffusion Spectral Imaging
Diffusion Spectral Imaging(DSI) is a newly proposed modification of DTI that allows potentially improved visualization of the complex white matter architecture.
Time frame: Baseline, two weeks, and four weeks
Quantitative susceptibility mapping
Quantitative susceptibility mapping(QSM) is widely used by the imaging research community in applications to detect iron. Tissue can become magnetized in response to a magnetic field, and the extent of magnetization is known as susceptibility, which arises from unpaired electrons in iron or external sources such as contrast agents. QSM permits visualization of the sizes and shapes of iron sources, delivers precise estimates of iron concentrations (units: parts per billion \[ppb\] or parts per million \[ppm\]).
Time frame: Baseline, two weeks, and four weeks
Monetary Incentive Delay Task
Participants see cues that they may win or lose money, then wait for a variable anticipatory delay period, and respond to a rapidly presented target with a single button press to try to either win or avoid losing money. Task-based functional magnetic resonance imaging (fMRI) will be used to assess neural activity during the Monetary Incentive Delay Task.
Time frame: Baseline, two weeks, and four weeks
Emotional faces processing task
Volunteers responded with a button press to each face with different emotions, indicating whether it was male or female. Task-based functional magnetic resonance imaging (fMRI) will be used to assess neural activity during the emotional faces processing task.
Time frame: Baseline, two weeks, and four weeks
Resting state functional connectivity
Resting-state functional connectivity will be assessed over a 10-minute period, focusing on functional connectivity between the medial prefrontal cortex and Lhb.
Time frame: Baseline, two weeks, and four weeks
Hamilton Anxiety Scale
Changes in Hamilton Anxiety Scale(HAMA-14). Score range from 0-56, higher scores mean a worse outcome.
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Clinical Global Impression
Changes in Clinical Global Impression(CGI)
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Snaith-Hamilton Pleasure Scale
Changes in Snaith-Hamilton Pleasure Scale(SHAPS). Score range from 14-56, higher scores mean a worse outcome.
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Insomnia Severity Index
Changes in Insomnia Severity Index(ISI). Score range from 0-28, higher scores mean a worse outcome.
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Columbia-Suicide Severity Rating Scale
Changes in Columbia-Suicide Severity Rating Scale(C-SSRS)
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Antidepressants Side Effects
Number of Participants with antidepressants side effects(SERS)
Time frame: One week, two weeks, four weeks, twelve weeks, twenty-four weeks
C-reactive protein
Changes in C-reactive protein(CRP)
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Tumor Necrosis Factor α
Changes in Tumor Necrosis Factor α(TNF-α)
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Interleukin- 6
Changes in interleukin- 6(IL-6)
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
N-back task
Changes in reaction time and accuracy
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Attention network test
Changes in reaction time and accuracy
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Psychomotor vigilance task
Changes in reaction time and accuracy
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Hamilton Depression Scale
Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome.
Time frame: Baseline, one week, twelve weeks, twenty-four weeks
Montgomery and asberg Depression Rating Scale
Changes in Montgomery and asberg (MADRS) Depression Rating Scale. Score range from 0-60, higher scores mean a worse outcome.
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Beck Depression Inventory
Changes in Beck Depression Inventory(BDI). Score range from 0-63, higher scores mean a worse outcome.
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
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