drugset / Trial / NCT06266715

Improvement of Depression With Use of ATP

NCT06266715

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-03-04
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject adenosine triphosphate Small molecule 100 mg Intravenous
Background Escitalopram Small molecule 10 mg Oral

Indications