Rapid Improvement of Depression of Fluoxetine Combined With ATP

Study Overview
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Drug: Control group: Fluoxetine and Placebo
* Drug: Experimental group: Fluoxetine and ATP
* Drug: Control group: Fluoxetine and Phosphocreatine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group: Fluoxetine and Placebo<br>Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks. | Drug: Control group: Fluoxetine and Placebo<br>* Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks.<br>|
| Experimental: Experimental group: Fluoxetine and ATP<br>Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks. | Drug: Experimental group: Fluoxetine and ATP<br>* Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks.<br>|
| Active Comparator: Control group: Fluoxetine and Phosphocreatine<br>Cap Fluoxetin 20mg OD for four weeks and injection phosphocreatine(1g) in NS BD for two weeks. | Drug: Control group: Fluoxetine and Phosphocreatine<br>* Cap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale | Changes in Hamilton Depression Scale（HAMD-24） | Baseline and one, two, four weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| structural brain networks | Changes in diffusion tensor imaging（DTI）and Diffusion Spectral Imaging(DSI) | Baseline and two, four weeks after treatment | 
| functional brain networks | Changes in functional magnetic resonance imaging（fMRI）and quantitative susceptibility mapping(QSM） | Baseline and two and four weeks after treatment | 
| Hamilton Anxiety Scale | Changes in Hamilton Anxiety Scale（HAMA） | Baseline and one, two, four weeks after treatment | 
| Clinical Global Impression | Changes in Clinical Global Impression（CGI） | Baseline and one, two, four weeks after treatment | 
| Snaith-Hamilton Pleasure Scale | Changes in Snaith-Hamilton Pleasure Scale（SHAPS） | Baseline and one, two, four weeks after treatment | 
| Insomnia Severity Index | Changes in Insomnia Severity Index（ISI） | Baseline and one, two, four weeks after treatment | 
| Patient Health Questionnaire | Changes in Patient Health Questionnaire（PHQ-9） | Baseline and one, two, four weeks after treatment | 
| Columbia-Suicide Severity Rating Scale | Changes in Columbia-Suicide Severity Rating Scale（C-SSRS) | Baseline and one, two, four weeks after treatment | 
| Antidepressants Side Effects | Number of Participants with antidepressants side effects（SERS） | Baseline and one, two, four weeks after treatment | 
| C-reaction protein | Changes in C-reaction protein（CRP） | Baseline and two and four weeks after treatment | 
| Tumor Necrosis Factor α | Changes in Tumor Necrosis Factor（TNF-α） | Baseline and two and four weeks after treatment | 
| interleukin- 6 | Changes in interleukin- 6（IL-6） | Baseline and two and four weeks after treatment | 
| N-back task | Changes in reaction time and accuracy | Baseline and two and four weeks after treatment | 
| Stroop task | Changes in reaction time and accuracy | Baseline and two and four weeks after treatment | 
| Psychomotor vigilance task | Changes in reaction time and accuracy | Baseline and two and four weeks after treatment | 
| Attention network test | Changes in reaction time and accuracy | Baseline and two and four weeks after treatment |