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Recruiting NCT06266715

Improvement of Depression With Use of ATP

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ATP Group, Placebo Group.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • HAMD-24 [Time frame: Baseline, two weeks, and four weeks]
Secondary outcome measures (12)
  • Diffusion Tensor Imaging [Time frame: Baseline, two weeks, and four weeks]
  • Diffusion Spectral Imaging [Time frame: Baseline, two weeks, and four weeks]
  • Quantitative susceptibility mapping [Time frame: Baseline, two weeks, and four weeks]
  • Monetary Incentive Delay Task [Time frame: Baseline, two weeks, and four weeks]
  • Emotional faces processing task [Time frame: Baseline, two weeks, and four weeks]
  • Resting state functional connectivity [Time frame: Baseline, two weeks, and four weeks]
  • Hamilton Anxiety Scale [Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks]
  • Clinical Global Impression [Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks]
  • Snaith-Hamilton Pleasure Scale [Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks]
  • Insomnia Severity Index [Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks]
  • Columbia-Suicide Severity Rating Scale [Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks]
  • Antidepressants Side Effects [Time frame: One week, two weeks, four weeks, twelve weeks, twenty-four weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanfang Hospital, Southern Medical University — Guangzhou

Publications

  • 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- PMID 40876882

Identifiers

NCT: NCT06266715 · NFEC-2024-070

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗