Improvement of Depression With Use of ATP

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Drug: ATP Group; Drug: Placebo Group

• Registration Number: NCT06266715
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-17
• Study First Posted: 2024-02-20
• Status Verified: 2024-03
• Study Start: 2024-03-04
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATP Group	ATP Group	Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.
Placebo Group	Placebo Group	Cap escitalopram 10mg once daily (OD) for four weeks and injection 110ml NS twice daily (BD) for two weeks.

Primary Outcome Measures

Name	Time	Method
HAMD-24	Baseline, two weeks, and four weeks	Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
Clinical Global Impression	Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks	Changes in Clinical Global Impression(CGI)
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)
Attention network test	Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks	Changes in reaction time and accuracy
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 \[ppm\]).
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.
Antidepressants Side Effects	One week, two weeks, four weeks, twelve weeks, twenty-four weeks	Number of Participants with antidepressants side effects(SERS)
C-reactive protein	Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks	Changes in C-reactive protein(CRP)
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
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.
Tumor Necrosis Factor α	Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks	Changes in Tumor Necrosis Factor α(TNF-α)
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.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China