Rapid Improvement of Depression of Fluoxetine Combined With ATP

Nanfang Hospital, Southern Medical University

Status and phase: Enrolling; Phase 2

Conditions: Depression

Treatments: Drug: Experimental group: Fluoxetine and ATP; Drug: Control group: Fluoxetine and Placebo; Drug: Control group: Fluoxetine and Phosphocreatine

Study type: Interventional

Funder types: Other

Identifiers

NCT05431413

NFEC-2020-153

Details and patient eligibility

About

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.

Enrollment: 195 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Meet DSM-V diagnostic criteria for moderate to severe depression.
• HAMD-24 scores ≥ 20.
• 18-65 female or male.
• Subjects who have not used any antipsychotic drugs, antidepressants, mood stabilizers (sodium valproate, lithium carbonate) or fluoxetine treatment within the first month prior to the start of this study
• Written informed consent.

Exclusion criteria

• Sufferring from various major mental disorders other than depression (such as bipolar disorder, schizophrenia, personality split, etc.).
• Individuals with neurological disorders such as dementia.
• Individuals with a high risk of suicide.
• Pregnant and lactating women.
• Individuals with alcohol or drug abuse or dependence within one year prior to the start of this study.
• 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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195 participants in 3 patient groups, including a placebo group

Control group: Fluoxetine and Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Control group: Fluoxetine and Placebo

Experimental group: Fluoxetine and ATP

Experimental group

Description:

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

Treatment:

Drug: Experimental group: Fluoxetine and ATP

Control group: Fluoxetine and Phosphocreatine

Active Comparator group

Description:

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

Treatment:

Drug: Control group: Fluoxetine and Phosphocreatine