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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Cap escitalopram 10mg once daily (OD) for four weeks and injection 110ml NS twice daily (BD) for two weeks. |
|
| ATP Group | Experimental | Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATP Group | Drug | Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HAMD-24 | Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome. | Baseline, two weeks, and four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, two weeks, and four weeks |
| Diffusion Spectral Imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Zhang, PhD | Contact | 86-020-62786731 | zhang73bin@hotmail.com | |
| Qianqian Xin, MMed | Contact | 86-020-62786731 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40876882 | Derived | Xin Q, Wei H, Paudel D, Hu N, Zhao Y, Feng Y, Luo X, Su M, Xue X, Huang H, Lv Z, Tang C, Zhao Y, Tan M, Luo X, Yang Y, Liu Q, Huang M, Cheng Y, Gao T, Zhang B. Intravenous administration of adenosine triphosphate combined with escitalopram in major depressive disorder: protocol for a randomised, double-blind, placebo-controlled trial. BMJ Open. 2025 Aug 28;15(8):e098281. doi: 10.1136/bmjopen-2024-098281. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Placebo Group | Drug | Cap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks. |
|
Diffusion Spectral Imaging(DSI) is a newly proposed modification of DTI that allows potentially improved visualization of the complex white matter architecture.
| 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]). | 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. | 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. | 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. | 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. | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks |
| Clinical Global Impression | Changes in Clinical Global Impression(CGI) | 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. | 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. | 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) | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks |
| Antidepressants Side Effects | Number of Participants with antidepressants side effects(SERS) | One week, two weeks, four weeks, twelve weeks, twenty-four weeks |
| C-reactive protein | Changes in C-reactive protein(CRP) | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks |
| Tumor Necrosis Factor α | Changes in Tumor Necrosis Factor α(TNF-α) | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks |
| Interleukin- 6 | Changes in interleukin- 6(IL-6) | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks |
| N-back task | Changes in reaction time and accuracy | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks |
| Attention network test | Changes in reaction time and accuracy | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks |
| Psychomotor vigilance task | Changes in reaction time and accuracy | 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. | 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. | 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. | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks |