Clinical trial NCT06266715: Improvement of Depression With Use of ATP
Official title: A Double-blind Randomized Controlled Trial of Adenosine Disodium Triphosphate in Improving Moderate to Severe Depressions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: HAMD-24
timeFrame: Baseline, two weeks, and four weeks
Secondary outcomes:
measure: Diffusion Tensor Imaging
timeFrame: Baseline, two weeks, and four weeks
measure: Diffusion Spectral Imaging
timeFrame: Baseline, two weeks, and four weeks
measure: Quantitative susceptibility mapping
timeFrame: Baseline, two weeks, and four weeks
measure: Monetary Incentive Delay Task
timeFrame: Baseline, two weeks, and four weeks
measure: Emotional faces processing task
timeFrame: Baseline, two weeks, and four weeks
measure: Resting state functional connectivity
timeFrame: Baseline, two weeks, and four weeks
measure: Hamilton Anxiety Scale
timeFrame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Clinical Global Impression
timeFrame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Snaith-Hamilton Pleasure Scale
timeFrame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Insomnia Severity Index
timeFrame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Antidepressants Side Effects
timeFrame: One week, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: C-reactive protein
timeFrame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Tumor Necrosis Factor α
timeFrame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Interleukin- 6
timeFrame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: N-back task
timeFrame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Attention network test
timeFrame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Psychomotor vigilance task
timeFrame: Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Hamilton Depression Scale
timeFrame: Baseline, one week, twelve weeks, twenty-four weeks
measure: Montgomery and asberg Depression Rating Scale
timeFrame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
measure: Beck Depression Inventory
timeFrame: Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References: