Rapid Improvement of Depression of Fluoxetine Combined With ATP
Fluoxetine Combined With ATP Rapidly Improves Moderate to Severe Depression: a Pilot Study
1 other identifier
interventional
195
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 depression
Started Jan 2020
Longer than P75 for phase_2 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2020
CompletedFirst Submitted
Initial submission to the registry
June 12, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedNovember 15, 2023
November 1, 2023
6 years
June 12, 2022
November 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Scale
Changes in Hamilton Depression Scale（HAMD-24）
Baseline and one, two, four weeks after treatment
Secondary Outcomes (16)
structural brain networks
Baseline and two, four weeks after treatment
functional brain networks
Baseline and two and four weeks after treatment
Hamilton Anxiety Scale
Baseline and one, two, four weeks after treatment
Clinical Global Impression
Baseline and one, two, four weeks after treatment
Snaith-Hamilton Pleasure Scale
Baseline and one, two, four weeks after treatment
- +11 more secondary outcomes
Study Arms (3)
Control group: Fluoxetine and Placebo
PLACEBO COMPARATORCap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks.
Experimental group: Fluoxetine and ATP
EXPERIMENTALCap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks.
Control group: Fluoxetine and Phosphocreatine
ACTIVE COMPARATORCap Fluoxetin 20mg OD for four weeks and injection phosphocreatine(1g) in NS BD for two weeks.
Interventions
Cap Fluoxetin 20mg OD for four weeks and injection 100ml normal saline(NS) BD for two weeks.
Cap Fluoxetin 20mg OD for four weeks and injection ATP 100mg in NS BD for two weeks.
Cap Fluoxetin 20mg OD for four weeks and injection Phosphocreatine 1g in NS BD for two weeks.
Eligibility Criteria
You may qualify if:
- Meet DSM-V diagnostic criteria for moderate to severe depression.
- HAMD-24 scores ≥ 20.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bin Zhang, MD & PhD
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2022
First Posted
June 24, 2022
Study Start
January 7, 2020
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
November 15, 2023
Record last verified: 2023-11