Rapid Improvement of Depression of Fluoxetine Combined With ATP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group: Fluoxetine and Placebo

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

Group Type PLACEBO_COMPARATOR

Control group: Fluoxetine and Placebo

Intervention Type DRUG

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

Experimental group: Fluoxetine and ATP

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

Group Type EXPERIMENTAL

Experimental group: Fluoxetine and ATP

Intervention Type DRUG

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

Control group: Fluoxetine and Phosphocreatine

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

Group Type ACTIVE_COMPARATOR

Control group: Fluoxetine and Phosphocreatine

Intervention Type DRUG

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

Interventions

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Control group: Fluoxetine and Placebo

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

Intervention Type DRUG

Experimental group: Fluoxetine and ATP

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

Intervention Type DRUG

Control group: Fluoxetine and Phosphocreatine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes