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Rapid Improvement of Depression of Fluoxetine Combined With ATP

NCT05431413 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2023-11-15

No results posted yet for this study

Summary

The clinical study is a randomized (1:1:1), double-blind, placebo-controlled clinical study. Recruit patients with moderate to severe depression. After signing the informed consent, patients who meet the inclusion criteria will be randomly assigned to the ATP group (fluoxetine combined with ATP) or phosphocreatine group (fluoxetine combined with phosphocreatine) or control group (fluoxetine combined with 0.9% sodium chloride) to received treatment. Then accessed scale, cognitive function and brain function before treatment and at one, two, and four weeks after treatment to initially explore the safety and efficacy of ATP combined with fluoxetine to rapidly improves moderate to severe depression.

Conditions

Interventions

DRUG

Control group: Fluoxetine and Placebo

Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks.

DRUG

Experimental group: Fluoxetine and ATP

Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks.

DRUG

Control group: Fluoxetine and Phosphocreatine

Cap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Bin Zhang, MD & PhD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05431413 on ClinicalTrials.gov