Depression
Conditions
Brief summary
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.
Interventions
DRUGControl group: Fluoxetine and Placebo
Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks.
DRUGExperimental group: Fluoxetine and ATP
Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks.
DRUGControl group: Fluoxetine and Phosphocreatine
Cap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale | Baseline and one, two, four weeks after treatment | Changes in Hamilton Depression Scale（HAMD-24） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| functional brain networks | Baseline and two and four weeks after treatment | Changes in functional magnetic resonance imaging（fMRI）and quantitative susceptibility mapping(QSM） |
| Hamilton Anxiety Scale | Baseline and one, two, four weeks after treatment | Changes in Hamilton Anxiety Scale（HAMA） |
| Clinical Global Impression | Baseline and one, two, four weeks after treatment | Changes in Clinical Global Impression（CGI） |
| Snaith-Hamilton Pleasure Scale | Baseline and one, two, four weeks after treatment | Changes in Snaith-Hamilton Pleasure Scale（SHAPS） |
| Insomnia Severity Index | Baseline and one, two, four weeks after treatment | Changes in Insomnia Severity Index（ISI） |
| Patient Health Questionnaire | Baseline and one, two, four weeks after treatment | Changes in Patient Health Questionnaire（PHQ-9） |
| Columbia-Suicide Severity Rating Scale | Baseline and one, two, four weeks after treatment | Changes in Columbia-Suicide Severity Rating Scale（C-SSRS) |
| structural brain networks | Baseline and two, four weeks after treatment | Changes in diffusion tensor imaging（DTI）and Diffusion Spectral Imaging(DSI) |
| C-reaction protein | Baseline and two and four weeks after treatment | Changes in C-reaction protein（CRP） |
| Tumor Necrosis Factor α | Baseline and two and four weeks after treatment | Changes in Tumor Necrosis Factor（TNF-α） |
| interleukin- 6 | Baseline and two and four weeks after treatment | Changes in interleukin- 6（IL-6） |
| N-back task | Baseline and two and four weeks after treatment | Changes in reaction time and accuracy |
| Stroop task | Baseline and two and four weeks after treatment | Changes in reaction time and accuracy |
| Psychomotor vigilance task | Baseline and two and four weeks after treatment | Changes in reaction time and accuracy |
| Attention network test | Baseline and two and four weeks after treatment | Changes in reaction time and accuracy |
| Antidepressants Side Effects | Baseline and one, two, four weeks after treatment | Number of Participants with antidepressants side effects（SERS） |
Countries
China
Contacts
Primary ContactBin Zhang, MD & PhD
Backup ContactQianqian Xin
Outcome results
None listed