Improvement of Depression With Use of ATP

A Double-blind Randomized Controlled Trial of Adenosine Disodium Triphosphate in Improving Moderate to Severe Depressions

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 Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Drug: Placebo Group; Drug: ATP Group

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bin Zhang, PhD; Phone Number: 86-020-62786731; Email: zhang73bin@hotmail.com
• Study Contact Backup: Name: Qianqian Xin, MMed; Phone Number: 86-020-62786731

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Qianqian Xin; Phone Number: 17664175246; Email: xinqianqian0126@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATP Group; Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.	Drug: ATP Group; Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.
Placebo Comparator: Placebo Group; Cap escitalopram 10mg once daily (OD) for four weeks and injection 110ml NS twice daily (BD) for two weeks.	Drug: Placebo Group; Cap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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
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
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
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
Tumor Necrosis Factor α	Changes in Tumor Necrosis Factor α(TNF-α)	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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: NFEC-2024-070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No