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Clinical Trials in China / NCT06266715
Recruiting Not applicable

Improvement of Depression With Use of ATP

NCT06266715 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-03-04
Last updated
2024-03-19

Condition(s) studied

Depression

Investigational drug(s) / intervention(s)

ATP GroupPlacebo Group

ATP Group: Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.

Placebo Group: Cap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nanfang Hospital, Southern Medical University Guangzhou Guangdong Recruiting

More Nanfang Hospital, Southern Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06266715 on ClinicalTrials.gov ↗ ← All trials in China