DepressionNCT06266715
Improvement of Depression With Use of ATP
A study testing ATP Group in people with Depression, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- ATP Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qianqian Xin, MMed contact
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Qianqian Xin, 17664175246, xinqianqian0126@163.com
About this study
Official title: A Double-blind Randomized Controlled Trial of Adenosine Disodium Triphosphate in Improving Moderate to Severe Depressions
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
- Being tested
- ATP Group, Placebo Group
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATP GroupDrug
Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.
Placebo GroupDrug
Cap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Cap escitalopram 10mg once daily (OD) for four weeks and injection 110ml NS twice daily (BD) for two weeks. Receives: Drug: Placebo Group |
| ATP Group | Experimental | Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks. Receives: Drug: ATP Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD-24
Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome.
Measured: Baseline, two weeks, and four weeks
Secondary outcomes (21)
Diffusion Tensor Imaging
Diffusion Tensor Imaging(DTI) is used to detect changes in fractional anisotropy (FA) maps of brain white matter fiber in major depressive patients.
Measured: Baseline, two weeks, and four weeks
Diffusion Spectral Imaging
Diffusion Spectral Imaging(DSI) is a newly proposed modification of DTI that allows potentially improved visualization of the complex white matter architecture.
Measured: Baseline, two weeks, and four weeks
Quantitative susceptibility mapping
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]).
Measured: Baseline, two weeks, and four weeks
Monetary Incentive Delay Task
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.
Measured: Baseline, two weeks, and four weeks
Emotional faces processing task
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.
Measured: Baseline, two weeks, and four weeks
Resting state functional connectivity
Resting-state functional connectivity will be assessed over a 10-minute period, focusing on functional connectivity between the medial prefrontal cortex and Lhb.
Measured: Baseline, two weeks, and four weeks
Hamilton Anxiety Scale
Changes in Hamilton Anxiety Scale(HAMA-14). Score range from 0-56, higher scores mean a worse outcome.
Measured: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Clinical Global Impression
Changes in Clinical Global Impression(CGI)
Measured: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Snaith-Hamilton Pleasure Scale
Changes in Snaith-Hamilton Pleasure Scale(SHAPS). Score range from 14-56, higher scores mean a worse outcome.
Measured: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Insomnia Severity Index
Changes in Insomnia Severity Index(ISI). Score range from 0-28, higher scores mean a worse outcome.
Measured: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Columbia-Suicide Severity Rating Scale
Changes in Columbia-Suicide Severity Rating Scale(C-SSRS)
Measured: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Antidepressants Side Effects
Number of Participants with antidepressants side effects(SERS)
Measured: One week, two weeks, four weeks, twelve weeks, twenty-four weeks
C-reactive protein
Changes in C-reactive protein(CRP)
Measured: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Tumor Necrosis Factor α
Changes in Tumor Necrosis Factor α(TNF-α)
Measured: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Interleukin- 6
Changes in interleukin- 6(IL-6)
Measured: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
N-back task
Changes in reaction time and accuracy
Measured: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Attention network test
Changes in reaction time and accuracy
Measured: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Psychomotor vigilance task
Changes in reaction time and accuracy
Measured: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Hamilton Depression Scale
Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome.
Measured: Baseline, one week, twelve weeks, twenty-four weeks
Montgomery and asberg Depression Rating Scale
Changes in Montgomery and asberg (MADRS) Depression Rating Scale. Score range from 0-60, higher scores mean a worse outcome.
Measured: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Beck Depression Inventory
Changes in Beck Depression Inventory(BDI). Score range from 0-63, higher scores mean a worse outcome.
Measured: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start4 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266715
- Sponsor's protocol ID
- NFEC-2024-070
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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-2024-098281.
PubMed 40876882
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Trial of Adenosine Disodium Triphosphate in Improving Moderate to Severe Depressions
- ClinicalTrials.gov ID
- NCT06266715
- Acronym / sponsor ID
- NFEC-2024-070
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebo GroupCap escitalopram 10mg once daily (OD) for four weeks and injection 110ml NS twice daily (BD) for two weeks. |
| ATP Group | Experimental | Drug: ATP GroupCap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATP GroupCap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks. | Drug | ATP Group |
| Placebo GroupCap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks. | Drug | Placebo Group |
Primary outcome
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.
21 secondary outcomes
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
C-reactive protein
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Tumor Necrosis Factor α
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Interleukin- 6
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
N-back task
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Attention network test
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Psychomotor vigilance task
Time frame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
Hamilton Depression Scale
Time frame: Baseline, one week, twelve weeks, twenty-four weeks
Montgomery and asberg Depression Rating Scale
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Beck Depression Inventory
Time frame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 40876882Xin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qianqian Xin, MMed contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATP Group in people with Depression, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Zhang, PhD (86-020-62786731, zhang73bin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAMD-24 (time frame: Baseline, two weeks, and four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.