Rapid Improvement of Depression of Fluoxetine Combined With ATP

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Drug: Control group: Fluoxetine and Placebo; Drug: Experimental group: Fluoxetine and ATP; Drug: Control group: Fluoxetine and Phosphocreatine

• Study Type: Interventional
• Enrollment (Estimated): 195
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bin Zhang, MD & PhD; Phone Number: 86-020-62786731; Email: zhang73bin@hotmail.com
• Study Contact Backup: Name: Qianqian Xin; Phone Number: 86-020-62786731; Email: xinqianqian0126@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Bin Zhang, MD＆PHD; Phone Number: 86-020-62786731; Email: zhang73bin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group: Fluoxetine and Placebo; 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 100ml normal saline(NS) BD for two weeks.
Experimental: Experimental group: Fluoxetine and ATP; 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 ATP 100mg in NS BD for two weeks.
Active Comparator: Control group: Fluoxetine and Phosphocreatine; 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 Phosphocreatine 1g in NS BD for two weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Bin Zhang, MD & PhD, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Selective Serotonin Reuptake Inhibitors; Fluoxetine; Phosphocreatine
• Other Study ID Numbers: NFEC-2020-153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No