NCT06266715

Improvement of Depression With Use of ATP

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	ATP Group	Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.
DRUG	Placebo Group	Cap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks.

Timeline

• Start date: 2024-03-04
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-02-20
• Last updated: 2024-03-19

Locations

1 site across 1 country: China