Rapid Improvement of Depression of Fluoxetine Combined With ATP

November 12, 2023 updated by: Nanfang Hospital, Southern Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
195

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hamilton Depression Scale
Time Frame: Baseline and one, two, four weeks after treatment
Changes in Hamilton Depression Scale（HAMD-24）
Baseline and one, two, four weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
structural brain networks
Time Frame: Baseline and two, four weeks after treatment
Changes in diffusion tensor imaging（DTI）and Diffusion Spectral Imaging(DSI)
Baseline and two, four weeks after treatment
functional brain networks
Time Frame: Baseline and two and four weeks after treatment
Changes in functional magnetic resonance imaging（fMRI）and quantitative susceptibility mapping(QSM）
Baseline and two and four weeks after treatment
Hamilton Anxiety Scale
Time Frame: Baseline and one, two, four weeks after treatment
Changes in Hamilton Anxiety Scale（HAMA）
Baseline and one, two, four weeks after treatment
Clinical Global Impression
Time Frame: Baseline and one, two, four weeks after treatment
Changes in Clinical Global Impression（CGI）
Baseline and one, two, four weeks after treatment
Snaith-Hamilton Pleasure Scale
Time Frame: Baseline and one, two, four weeks after treatment
Changes in Snaith-Hamilton Pleasure Scale（SHAPS）
Baseline and one, two, four weeks after treatment
Insomnia Severity Index
Time Frame: Baseline and one, two, four weeks after treatment
Changes in Insomnia Severity Index（ISI）
Baseline and one, two, four weeks after treatment
Patient Health Questionnaire
Time Frame: Baseline and one, two, four weeks after treatment
Changes in Patient Health Questionnaire（PHQ-9）
Baseline and one, two, four weeks after treatment
Columbia-Suicide Severity Rating Scale
Time Frame: Baseline and one, two, four weeks after treatment
Changes in Columbia-Suicide Severity Rating Scale（C-SSRS)
Baseline and one, two, four weeks after treatment
Antidepressants Side Effects
Time Frame: Baseline and one, two, four weeks after treatment
Number of Participants with antidepressants side effects（SERS）
Baseline and one, two, four weeks after treatment
C-reaction protein
Time Frame: Baseline and two and four weeks after treatment
Changes in C-reaction protein（CRP）
Baseline and two and four weeks after treatment
Tumor Necrosis Factor α
Time Frame: Baseline and two and four weeks after treatment
Changes in Tumor Necrosis Factor（TNF-α）
Baseline and two and four weeks after treatment
interleukin- 6
Time Frame: Baseline and two and four weeks after treatment
Changes in interleukin- 6（IL-6）
Baseline and two and four weeks after treatment
N-back task
Time Frame: Baseline and two and four weeks after treatment
Changes in reaction time and accuracy
Baseline and two and four weeks after treatment
Stroop task
Time Frame: Baseline and two and four weeks after treatment
Changes in reaction time and accuracy
Baseline and two and four weeks after treatment
Psychomotor vigilance task
Time Frame: Baseline and two and four weeks after treatment
Changes in reaction time and accuracy
Baseline and two and four weeks after treatment
Attention network test
Time Frame: Baseline and two and four weeks after treatment
Changes in reaction time and accuracy
Baseline and two and four weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital, Southern Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bin Zhang, MD & PhD, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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