Improvement of Depression With Use of ATP

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Depression

Treatments: Drug: Placebo Group; Drug: ATP Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06266715

NFEC-2024-070

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Group

ATP Group

Experimental group

Description:

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

Treatment:

Drug: ATP Group