DepressionPhase 2NCT05431413
Rapid Improvement of Depression of Fluoxetine Combined With ATP
A Phase 2 study testing Experimental group: Fluoxetine and ATP in people with Depression, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Experimental group: Fluoxetine and ATP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2020to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Bin Zhang, MD＆PHD, 86-020-62786731, zhang73bin@hotmail.com
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- Control group: Fluoxetine and Placebo, Experimental group: Fluoxetine and ATP, Control group: Fluoxetine and Phosphocreatine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group: Fluoxetine and PlaceboDrug
Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks.
Experimental group: Fluoxetine and ATPDrug
Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks.
Control group: Fluoxetine and PhosphocreatineDrug
Cap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Fluoxetine and Placebo | Placebo comparator | Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks. Receives: Drug: Control group: Fluoxetine and Placebo |
| Experimental group: Fluoxetine and ATP | Experimental | Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks. Receives: Drug: Experimental group: Fluoxetine and ATP |
| Control group: Fluoxetine and Phosphocreatine | Active comparator | Cap Fluoxetin 20mg OD for four weeks and injection phosphocreatine(1g) in NS BD for two weeks. Receives: Drug: Control group: Fluoxetine and Phosphocreatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale
Changes in Hamilton Depression Scale（HAMD-24）
Measured: Baseline and one, two, four weeks after treatment
Secondary outcomes (16)
structural brain networks
Changes in diffusion tensor imaging（DTI）and Diffusion Spectral Imaging(DSI)
Measured: Baseline and two, four weeks after treatment
functional brain networks
Changes in functional magnetic resonance imaging（fMRI）and quantitative susceptibility mapping(QSM）
Measured: Baseline and two and four weeks after treatment
Hamilton Anxiety Scale
Changes in Hamilton Anxiety Scale（HAMA）
Measured: Baseline and one, two, four weeks after treatment
Clinical Global Impression
Changes in Clinical Global Impression（CGI）
Measured: Baseline and one, two, four weeks after treatment
Snaith-Hamilton Pleasure Scale
Changes in Snaith-Hamilton Pleasure Scale（SHAPS）
Measured: Baseline and one, two, four weeks after treatment
Insomnia Severity Index
Changes in Insomnia Severity Index（ISI）
Measured: Baseline and one, two, four weeks after treatment
Patient Health Questionnaire
Changes in Patient Health Questionnaire（PHQ-9）
Measured: Baseline and one, two, four weeks after treatment
Columbia-Suicide Severity Rating Scale
Changes in Columbia-Suicide Severity Rating Scale（C-SSRS)
Measured: Baseline and one, two, four weeks after treatment
Antidepressants Side Effects
Number of Participants with antidepressants side effects（SERS）
Measured: Baseline and one, two, four weeks after treatment
C-reaction protein
Changes in C-reaction protein（CRP）
Measured: Baseline and two and four weeks after treatment
Tumor Necrosis Factor α
Changes in Tumor Necrosis Factor（TNF-α）
Measured: Baseline and two and four weeks after treatment
interleukin- 6
Changes in interleukin- 6（IL-6）
Measured: Baseline and two and four weeks after treatment
N-back task
Changes in reaction time and accuracy
Measured: Baseline and two and four weeks after treatment
Stroop task
Changes in reaction time and accuracy
Measured: Baseline and two and four weeks after treatment
Psychomotor vigilance task
Changes in reaction time and accuracy
Measured: Baseline and two and four weeks after treatment
Attention network test
Changes in reaction time and accuracy
Measured: Baseline and two and four weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start7 Jan 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Zhang, MD & PhD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431413
- Sponsor's protocol ID
- NFEC-2020-153
- Status last verified
- Nov 2023
- First submitted
- 12 Jun 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoxetine Combined With ATP Rapidly Improves Moderate to Severe Depression: a Pilot Study
- ClinicalTrials.gov ID
- NCT05431413
- Acronym / sponsor ID
- NFEC-2020-153
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group: Fluoxetine and Placebo | Placebo comparator | Drug: Control group: Fluoxetine and PlaceboCap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks. |
| Experimental group: Fluoxetine and ATP | Experimental | Drug: Experimental group: Fluoxetine and ATPCap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks. |
| Control group: Fluoxetine and Phosphocreatine | Active comparator | Drug: Control group: Fluoxetine and PhosphocreatineCap Fluoxetin 20mg OD for four weeks and injection phosphocreatine(1g) in NS BD for two weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group: Fluoxetine and PlaceboCap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks. | Drug | Control group: Fluoxetine and Placebo |
| Experimental group: Fluoxetine and ATPCap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks. | Drug | Experimental group: Fluoxetine and ATP |
| Control group: Fluoxetine and PhosphocreatineCap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks. | Drug | Control group: Fluoxetine and Phosphocreatine |
Primary outcome
Hamilton Depression Scale
Time frame: Baseline and one, two, four weeks after treatment
Changes in Hamilton Depression Scale（HAMD-24）
16 secondary outcomes
structural brain networks
Time frame: Baseline and two, four weeks after treatment
functional brain networks
Time frame: Baseline and two and four weeks after treatment
Hamilton Anxiety Scale
Time frame: Baseline and one, two, four weeks after treatment
Clinical Global Impression
Time frame: Baseline and one, two, four weeks after treatment
Snaith-Hamilton Pleasure Scale
Time frame: Baseline and one, two, four weeks after treatment
Insomnia Severity Index
Time frame: Baseline and one, two, four weeks after treatment
Patient Health Questionnaire
Time frame: Baseline and one, two, four weeks after treatment
Columbia-Suicide Severity Rating Scale
Time frame: Baseline and one, two, four weeks after treatment
Antidepressants Side Effects
Time frame: Baseline and one, two, four weeks after treatment
C-reaction protein
Time frame: Baseline and two and four weeks after treatment
Tumor Necrosis Factor α
Time frame: Baseline and two and four weeks after treatment
interleukin- 6
Time frame: Baseline and two and four weeks after treatment
N-back task
Time frame: Baseline and two and four weeks after treatment
Stroop task
Time frame: Baseline and two and four weeks after treatment
Psychomotor vigilance task
Time frame: Baseline and two and four weeks after treatment
Attention network test
Time frame: Baseline and two and four weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Zhang, MD & PhD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental group: Fluoxetine and ATP in people with Depression, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Zhang, MD & PhD (86-020-62786731, zhang73bin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale (time frame: Baseline and one, two, four weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.