protocolSection identificationModule nctId: NCT06266715, orgStudyIdInfo id: NFEC-2024-070, briefTitle: Improvement of Depression With Use of ATP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ATP Group, interventions name: Placebo Group, outcomesModule primaryOutcomes measure: HAMD-24, secondaryOutcomes measure: Diffusion Tensor Imaging, secondaryOutcomes measure: Diffusion Spectral Imaging, secondaryOutcomes measure: Quantitative susceptibility mapping, secondaryOutcomes measure: Monetary Incentive Delay Task, secondaryOutcomes measure: Emotional faces processing task, secondaryOutcomes measure: Resting state functional connectivity, secondaryOutcomes measure: Hamilton Anxiety Scale, secondaryOutcomes measure: Clinical Global Impression, secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: Columbia-Suicide Severity Rating Scale, secondaryOutcomes measure: Antidepressants Side Effects, secondaryOutcomes measure: C-reactive protein, secondaryOutcomes measure: Tumor Necrosis Factor α, secondaryOutcomes measure: Interleukin- 6, secondaryOutcomes measure: N-back task, secondaryOutcomes measure: Attention network test, secondaryOutcomes measure: Psychomotor vigilance task, secondaryOutcomes measure: Hamilton Depression Scale, secondaryOutcomes measure: Montgomery and asberg Depression Rating Scale, secondaryOutcomes measure: Beck Depression Inventory, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Qianqian Xin, role: CONTACT, phone: 17664175246, email: xinqianqian0126@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False