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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group: Fluoxetine and Placebo | Placebo Comparator | Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks. |
|
| Experimental group: Fluoxetine and ATP | Experimental | Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks. |
|
| Control group: Fluoxetine and Phosphocreatine | Active Comparator | Cap Fluoxetin 20mg OD for four weeks and injection phosphocreatine(1g) in NS BD for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group: Fluoxetine and Placebo | Drug | Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale | Changes in Hamilton Depression Scale（HAMD-24） | Baseline and one, two, four weeks after treatment |
| 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） |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Zhang, MD & PhD | Contact | 86-020-62786731 | zhang73bin@hotmail.com | |
| Qianqian Xin | Contact | 86-020-62786731 | xinqianqian0126@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Zhang, MD & PhD | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000255 | Adenosine Triphosphate |
| D010725 | Phosphocreatine |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Experimental group: Fluoxetine and ATP | Drug | Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks. |
|
| Control group: Fluoxetine and Phosphocreatine | Drug | Cap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks. |
|
| 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 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D003401 | Creatine |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019606 | Phosphoamino Acids |