Depression
Conditions
Brief summary
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.
Interventions
DRUGATP Group
Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.
DRUGPlacebo Group
Cap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet the diagnostic and statistical manual of mental disorders-5 diagnostic criteria for moderate to severe depression. * HAMD-24 scores ≥ 20. * 18-65 female or male. * Participants who have not used any psychotropic medications within one month prior to study and never had a treatment with escitalopram. * Individuals without contraindications to selective serotonin reuptake inhibitor. * Individuals without contraindications to ATP. * Written informed consent.
Exclusion criteria
* Participants with various major mental disorders other than depression (bipolar disorder, any psychotic disorder, Personality Disorders, alcohol use disorder, substance use disorder, and disorders due to medical or organic cause) assessed using Chinese version of the Mini International Neuropsychiatric Interview (MINI). * Individuals with neurological disorders such as dementia. * Individuals with a high risk of suicide. * Pregnant and lactating women. * Contraindications to MRI. * Physician evaluation was not suitable for participants in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAMD-24 | Baseline, two weeks, and four weeks | Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diffusion Spectral Imaging | Baseline, two weeks, and four weeks | Diffusion Spectral Imaging(DSI) is a newly proposed modification of DTI that allows potentially improved visualization of the complex white matter architecture. |
| Quantitative susceptibility mapping | Baseline, two weeks, and four weeks | 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 \[ppm\]). |
| Monetary Incentive Delay Task | Baseline, two weeks, and four weeks | 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. |
| Emotional faces processing task | Baseline, two weeks, and four weeks | 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. |
| Resting state functional connectivity | Baseline, two weeks, and four weeks | Resting-state functional connectivity will be assessed over a 10-minute period, focusing on functional connectivity between the medial prefrontal cortex and Lhb. |
| Hamilton Anxiety Scale | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in Hamilton Anxiety Scale(HAMA-14). Score range from 0-56, higher scores mean a worse outcome. |
| Clinical Global Impression | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in Clinical Global Impression(CGI) |
| Snaith-Hamilton Pleasure Scale | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in Snaith-Hamilton Pleasure Scale(SHAPS). Score range from 14-56, higher scores mean a worse outcome. |
| Insomnia Severity Index | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in Insomnia Severity Index(ISI). Score range from 0-28, higher scores mean a worse outcome. |
| Columbia-Suicide Severity Rating Scale | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in Columbia-Suicide Severity Rating Scale(C-SSRS) |
| Diffusion Tensor Imaging | Baseline, two weeks, and four weeks | Diffusion Tensor Imaging(DTI) is used to detect changes in fractional anisotropy (FA) maps of brain white matter fiber in major depressive patients. |
| C-reactive protein | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in C-reactive protein(CRP) |
| Tumor Necrosis Factor α | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in Tumor Necrosis Factor α(TNF-α) |
| Interleukin- 6 | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in interleukin- 6(IL-6) |
| N-back task | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in reaction time and accuracy |
| Attention network test | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in reaction time and accuracy |
| Psychomotor vigilance task | Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in reaction time and accuracy |
| Hamilton Depression Scale | Baseline, one week, twelve weeks, twenty-four weeks | Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome. |
| Montgomery and asberg Depression Rating Scale | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in Montgomery and asberg (MADRS) Depression Rating Scale. Score range from 0-60, higher scores mean a worse outcome. |
| Beck Depression Inventory | Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks | Changes in Beck Depression Inventory(BDI). Score range from 0-63, higher scores mean a worse outcome. |
| Antidepressants Side Effects | One week, two weeks, four weeks, twelve weeks, twenty-four weeks | Number of Participants with antidepressants side effects(SERS) |
Countries
China
Contacts
Primary ContactBin Zhang, PhD
Backup ContactQianqian Xin, MMed
Outcome results
None listed