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NCT Number: NCT06266715

Improvement of Depression With Use of ATP

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location status: Recruiting

Location contact

Qianqian Xin

CONTACT

[email protected]

17664175246

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATP Group

Drug

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

Placebo Group

Drug

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

Primary outcomes

  1. HAMD-24

    Time frame: Baseline, two weeks, and four weeks

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

Secondary outcomes

  1. Diffusion Tensor Imaging

    Time frame: Baseline, two weeks, and four weeks

    Diffusion Tensor Imaging(DTI) is used to detect changes in fractional anisotropy (FA) maps of brain white matter fiber in major depressive patients.

  2. Diffusion Spectral Imaging

    Time frame: Baseline, two weeks, and four weeks

    Diffusion Spectral Imaging(DSI) is a newly proposed modification of DTI that allows potentially improved visualization of the complex white matter architecture.

  3. Quantitative susceptibility mapping

    Time frame: Baseline, two weeks, and four weeks

    Quantitative susceptibility mapping(QSM) is widely used by the imaging research community in applications to detect iron. Tissue can become magnetized in response to a magnetic field, and the extent of magnetization is known as susceptibility, which arises from unpaired electrons in iron or external sources such as contrast agents. QSM permits visualization of the sizes and shapes of iron sources, delivers precise estimates of iron concentrations (units: parts per billion [ppb] or parts per million [ppm]).

  4. Monetary Incentive Delay Task

    Time frame: Baseline, two weeks, and four weeks

    Participants see cues that they may win or lose money, then wait for a variable anticipatory delay period, and respond to a rapidly presented target with a single button press to try to either win or avoid losing money.

    Task-based functional magnetic resonance imaging (fMRI) will be used to assess neural activity during the Monetary Incentive Delay Task.

  5. Emotional faces processing task

    Time frame: Baseline, two weeks, and four weeks

    Volunteers responded with a button press to each face with different emotions, indicating whether it was male or female.

    Task-based functional magnetic resonance imaging (fMRI) will be used to assess neural activity during the emotional faces processing task.

  6. Resting state functional connectivity

    Time frame: Baseline, two weeks, and four weeks

    Resting-state functional connectivity will be assessed over a 10-minute period, focusing on functional connectivity between the medial prefrontal cortex and Lhb.

  7. Hamilton Anxiety Scale

    Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in Hamilton Anxiety Scale(HAMA-14). Score range from 0-56, higher scores mean a worse outcome.

  8. Clinical Global Impression

    Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in Clinical Global Impression(CGI)

  9. Snaith-Hamilton Pleasure Scale

    Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in Snaith-Hamilton Pleasure Scale(SHAPS). Score range from 14-56, higher scores mean a worse outcome.

  10. Insomnia Severity Index

    Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in Insomnia Severity Index(ISI). Score range from 0-28, higher scores mean a worse outcome.

  11. Columbia-Suicide Severity Rating Scale

    Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in Columbia-Suicide Severity Rating Scale(C-SSRS)

  12. Antidepressants Side Effects

    Time frame: One week, two weeks, four weeks, twelve weeks, twenty-four weeks

    Number of Participants with antidepressants side effects(SERS)

  13. C-reactive protein

    Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in C-reactive protein(CRP)

  14. Tumor Necrosis Factor α

    Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in Tumor Necrosis Factor α(TNF-α)

  15. Interleukin- 6

    Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in interleukin- 6(IL-6)

  16. N-back task

    Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in reaction time and accuracy

  17. Attention network test

    Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in reaction time and accuracy

  18. Psychomotor vigilance task

    Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in reaction time and accuracy

  19. Hamilton Depression Scale

    Time frame: Baseline, one week, twelve weeks, twenty-four weeks

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

  20. Montgomery and asberg Depression Rating Scale

    Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in Montgomery and asberg (MADRS) Depression Rating Scale. Score range from 0-60, higher scores mean a worse outcome.

  21. Beck Depression Inventory

    Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks

    Changes in Beck Depression Inventory(BDI). Score range from 0-63, higher scores mean a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Zhang, PhD

CONTACT

[email protected]

86-020-62786731

Qianqian Xin, MMed

CONTACT

86-020-62786731

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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