Rapid Antidepressant Effects of ATP and Phosphocreatine

Study Overview
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Brief Summary
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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.

Official Title
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A Preliminary Clinical Study on the Rapid Antidepressant Effects of Adenosine Triphosphate (ATP) and Phosphocreatine Combinated With Fluoxetine

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: ATP
* Drug: Phosphocreatine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo is given intravenously twice a day for 14 days<br>|
| Experimental: ATP<br> | Drug: ATP<br>* ATP (100mg) is given intravenously twice a day for 14 days<br>|
| Experimental: phosphocreatine<br> | Drug: Phosphocreatine<br>* Phosphocreatine (1g) is given intravenously twice a day for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hamilton depression rating scale during the first six weeks |  | baseline, 1st, 2nd, 4th, 6th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |