Improvement of Depression With Use of ATP

NCT06266715 | Recruiting DMC

• 1 other identifier: NFEC-2024-070
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• HAMD-24

  Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome.

  Baseline, two weeks, and four weeks

Secondary Outcomes (21)

• Diffusion Tensor Imaging

  Baseline, two weeks, and four weeks

• Diffusion Spectral Imaging

  Baseline, two weeks, and four weeks

• Quantitative susceptibility mapping

  Baseline, two weeks, and four weeks

• Monetary Incentive Delay Task

  Baseline, two weeks, and four weeks

• Emotional faces processing task

  Baseline, two weeks, and four weeks

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Cap escitalopram 10mg once daily (OD) for four weeks and injection 110ml NS twice daily (BD) for two weeks.

Drug: Placebo Group

ATP Group

EXPERIMENTAL

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

Drug: ATP Group

Interventions

ATP Group DRUG

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

ATP Group

Placebo Group DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic and statistical manual of mental disorders-5 diagnostic criteria for moderate to severe depression.
• HAMD-24 scores ≥ 20.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

• Xin Q, Wei H, Paudel D, Hu N, Zhao Y, Feng Y, Luo X, Su M, Xue X, Huang H, Lv Z, Tang C, Zhao Y, Tan M, Luo X, Yang Y, Liu Q, Huang M, Cheng Y, Gao T, Zhang B. Intravenous administration of adenosine triphosphate combined with escitalopram in major depressive disorder: protocol for a randomised, double-blind, placebo-controlled trial. BMJ Open. 2025 Aug 28;15(8):e098281. doi: 10.1136/bmjopen-2024-098281.

  PMID: 40876882 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Bin Zhang, PhD

CONTACT

86-020-62786731; zhang73bin@hotmail.com

Qianqian Xin, MMed

CONTACT

86-020-62786731

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 20, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CN (1)