Rapid Improvement of Depression of Fluoxetine Combined With ATP

Phase 2

Recruiting

• Conditions: Depression

• Registration Number: NCT05431413
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-12
• Last Update Posted: 2023-11-15
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 195

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale	Baseline and one, two, four weeks after treatment	Changes in Hamilton Depression Scale（HAMD-24）

Secondary Outcome Measures

Name	Time	Method
Stroop task	Baseline and two and four weeks after treatment	Changes in reaction time and accuracy
Hamilton Anxiety Scale	Baseline and one, two, four weeks after treatment	Changes in Hamilton Anxiety Scale（HAMA）
Snaith-Hamilton Pleasure Scale	Baseline and one, two, four weeks after treatment	Changes in Snaith-Hamilton Pleasure Scale（SHAPS）
Patient Health Questionnaire	Baseline and one, two, four weeks after treatment	Changes in Patient Health Questionnaire（PHQ-9）
structural brain networks	Baseline and two, four weeks after treatment	Changes in diffusion tensor imaging（DTI）and Diffusion Spectral Imaging(DSI)
functional brain networks	Baseline and two and four weeks after treatment	Changes in functional magnetic resonance imaging（fMRI）and quantitative susceptibility mapping(QSM）
Columbia-Suicide Severity Rating Scale	Baseline and one, two, four weeks after treatment	Changes in Columbia-Suicide Severity Rating Scale（C-SSRS)
Antidepressants Side Effects	Baseline and one, two, four weeks after treatment	Number of Participants with antidepressants side effects（SERS）
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
Psychomotor vigilance task	Baseline and two and four weeks after treatment	Changes in reaction time and accuracy
Clinical Global Impression	Baseline and one, two, four weeks after treatment	Changes in Clinical Global Impression（CGI）
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）
Attention network test	Baseline and two and four weeks after treatment	Changes in reaction time and accuracy
Insomnia Severity Index	Baseline and one, two, four weeks after treatment	Changes in Insomnia Severity Index（ISI）

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China