Rapid Improvement of Depression of Fluoxetine Combined With ATP

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431413
• Other study ID #: NFEC-2020-153
• Status: Recruiting
• Phase: Phase 2
• Start date: January 7, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Bin Zhang, MD & PhD
• Phone: 86-020-62786731
• Email: zhang73bin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Control group: Fluoxetine and Placebo
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.
• Control group: Fluoxetine and Phosphocreatine
Cap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale	Changes in Hamilton Depression Scale(HAMD-24)	Baseline and one, two, four weeks after treatment
Secondary	structural brain networks	Changes in diffusion tensor imaging(DTI)and Diffusion Spectral Imaging(DSI)	Baseline and two, four weeks after treatment
Secondary	functional brain networks	Changes in functional magnetic resonance imaging(fMRI)and quantitative susceptibility mapping(QSM)	Baseline and two and four weeks after treatment
Secondary	Hamilton Anxiety Scale	Changes in Hamilton Anxiety Scale(HAMA)	Baseline and one, two, four weeks after treatment
Secondary	Clinical Global Impression	Changes in Clinical Global Impression(CGI)	Baseline and one, two, four weeks after treatment
Secondary	Snaith-Hamilton Pleasure Scale	Changes in Snaith-Hamilton Pleasure Scale(SHAPS)	Baseline and one, two, four weeks after treatment
Secondary	Insomnia Severity Index	Changes in Insomnia Severity Index(ISI)	Baseline and one, two, four weeks after treatment
Secondary	Patient Health Questionnaire	Changes in Patient Health Questionnaire(PHQ-9)	Baseline and one, two, four weeks after treatment
Secondary	Columbia-Suicide Severity Rating Scale	Changes in Columbia-Suicide Severity Rating Scale(C-SSRS)	Baseline and one, two, four weeks after treatment
Secondary	Antidepressants Side Effects	Number of Participants with antidepressants side effects(SERS)	Baseline and one, two, four weeks after treatment
Secondary	C-reaction protein	Changes in C-reaction protein(CRP)	Baseline and two and four weeks after treatment
Secondary	Tumor Necrosis Factor a	Changes in Tumor Necrosis Factor(TNF-a)	Baseline and two and four weeks after treatment
Secondary	interleukin- 6	Changes in interleukin- 6(IL-6)	Baseline and two and four weeks after treatment
Secondary	N-back task	Changes in reaction time and accuracy	Baseline and two and four weeks after treatment
Secondary	Stroop task	Changes in reaction time and accuracy	Baseline and two and four weeks after treatment
Secondary	Psychomotor vigilance task	Changes in reaction time and accuracy	Baseline and two and four weeks after treatment
Secondary	Attention network test	Changes in reaction time and accuracy	Baseline and two and four weeks after treatment