Rapid Antidepressant Effects of ATP and Phosphocreatine
A Preliminary Clinical Study on the Rapid Antidepressant Effects of Adenosine Triphosphate (ATP) and Phosphocreatine Combinated With Fluoxetine
1 other identifier
interventional
42
1 country
1
Brief Summary
This is a preliminary, double-blind clinical trail aimed to investigate whether the combination of fluoxetine with ATP or phosphocreatine has a rapid antidepressant effect. 42 patients with major depressive disorder (Hamilton Depression Rating Scale (HAMD) score \>= 20) will be recruited and divided into 3 groups randomly. This study involves two periods. In the first period, one group will be treated with fluoxetine and placebo, one with fluoxetine and ATP, and one with fluoxetine and phosphocreatine for 2 weeks. Placebo, ATP and phosphocreatine will be given intravenously, and fluoxetine orally. In the second period, each patient will be only given fluoxetine for 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 major-depressive-disorder
Started May 2017
Typical duration for phase_2 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedStudy Start
First participant enrolled
May 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedMay 8, 2017
April 1, 2017
2 years
April 24, 2017
May 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Hamilton depression rating scale during the first six weeks
baseline, 1st, 2nd, 4th, 6th week
Secondary Outcomes (3)
Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks
baseline, 1st, 2nd, 4th, 6th week
Changes in Clinical global impression scale during the study
baseline, 2nd, 4th, 10th week
Side effects assessment during the first six weeks
1st, 2nd, 4th, 6th week
Study Arms (3)
Placebo
PLACEBO COMPARATORATP
EXPERIMENTALphosphocreatine
EXPERIMENTALInterventions
Phosphocreatine (1g) is given intravenously twice a day for 14 days
Eligibility Criteria
You may qualify if:
- year-old male or female
- Major depressive disorder diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Hamilton depression rating scale score \>= 20 at screening
- Written informed consent
You may not qualify if:
- Participants of other clinical trials in recent 4 weeks
- Suicidal idea or action that requires hospitalization
- Post Traumatic Stress Syndrome in recent 6 months
- Secondary depression, or have a direct familial history of schizophrenia
- Diseases that prevent from appropriate expression of depressive emotion
- Psychiatric disorders including bipolar disorder and schizophrenia
- Severe heart, kidney, lung or liver diseases that require hospitalization
- Diabetes
- Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
- Inflammatory disease including autoimmune disease
- Taking anti-inflammatory medication
- Taking antiarrhythmic drugs, antidiabetic agents or tryptophan
- Substance abuse or dependence history in recent 6 months
- Pregnant or having plan to be pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhujiang Hospital
Guangzhou, Guangdong, 510280, China
Related Publications (1)
Chen Y, Cao X, Zang W, Tan S, Ou CQ, Shen X, Gao T, Zhao L. Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study. Trials. 2019 Jan 9;20(1):34. doi: 10.1186/s13063-018-3115-4.
PMID: 30626424DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
April 24, 2017
First Posted
May 3, 2017
Study Start
May 3, 2017
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
May 8, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share