A Phase 2 interventional study of Control group: Fluoxetine and Placebo and Experimental group: Fluoxetine and ATP in Depression, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 2, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 195 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks.
Drug: Control group: Fluoxetine and Placebo
Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks.
Drug: Experimental group: Fluoxetine and ATP
Cap Fluoxetin 20mg OD for four weeks and injection phosphocreatine(1g) in NS BD for two weeks.
Drug: Control group: Fluoxetine and Phosphocreatine
Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks.
Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks.
Cap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks.
Hamilton Depression Scale
Changes in Hamilton Depression Scale（HAMD-24）
Time frame: Baseline and one, two, four weeks after treatment
structural brain networks
Changes in diffusion tensor imaging（DTI）and Diffusion Spectral Imaging(DSI)
Time frame: Baseline and two, four weeks after treatment
functional brain networks
Changes in functional magnetic resonance imaging（fMRI）and quantitative susceptibility mapping(QSM）
Time frame: Baseline and two and four weeks after treatment
Hamilton Anxiety Scale
Changes in Hamilton Anxiety Scale（HAMA）
Time frame: Baseline and one, two, four weeks after treatment
Clinical Global Impression
Changes in Clinical Global Impression（CGI）
Time frame: Baseline and one, two, four weeks after treatment
Snaith-Hamilton Pleasure Scale
Changes in Snaith-Hamilton Pleasure Scale（SHAPS）
Time frame: Baseline and one, two, four weeks after treatment
Insomnia Severity Index
Changes in Insomnia Severity Index（ISI）
Time frame: Baseline and one, two, four weeks after treatment
Patient Health Questionnaire
Changes in Patient Health Questionnaire（PHQ-9）
Time frame: Baseline and one, two, four weeks after treatment
Columbia-Suicide Severity Rating Scale
Changes in Columbia-Suicide Severity Rating Scale（C-SSRS)
Time frame: Baseline and one, two, four weeks after treatment
Antidepressants Side Effects
Number of Participants with antidepressants side effects（SERS）
Time frame: Baseline and one, two, four weeks after treatment
C-reaction protein
Changes in C-reaction protein（CRP）
Time frame: Baseline and two and four weeks after treatment
Tumor Necrosis Factor α
Changes in Tumor Necrosis Factor（TNF-α）
Time frame: Baseline and two and four weeks after treatment
interleukin- 6
Changes in interleukin- 6（IL-6）
Time frame: Baseline and two and four weeks after treatment
N-back task
Changes in reaction time and accuracy
Time frame: Baseline and two and four weeks after treatment
Stroop task
Changes in reaction time and accuracy
Time frame: Baseline and two and four weeks after treatment
Psychomotor vigilance task
Changes in reaction time and accuracy
Time frame: Baseline and two and four weeks after treatment
Attention network test
Changes in reaction time and accuracy
Time frame: Baseline and two and four weeks after treatment
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Nanfang Hospital, Southern Medical University