NCT05431413

Rapid Improvement of Depression of Fluoxetine Combined With ATP

Fluoxetine Combined With ATP Rapidly Improves Moderate to Severe Depression: a Pilot Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-07
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-06-24
• Last updated: 2023-11-15

Locations

1 site across 1 country: China