Clinical trial NCT03138681: Rapid Antidepressant Effects of ATP and Phosphocreatine
Official title: A Preliminary Clinical Study on the Rapid Antidepressant Effects of Adenosine Triphosphate (ATP) and Phosphocreatine Combinated With Fluoxetine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Hamilton depression rating scale during the first six weeks
timeFrame: baseline, 1st, 2nd, 4th, 6th week
Secondary outcomes:
measure: Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks
timeFrame: baseline, 1st, 2nd, 4th, 6th week
measure: Changes in Clinical global impression scale during the study
timeFrame: baseline, 2nd, 4th, 10th week
measure: Side effects assessment during the first six weeks
timeFrame: 1st, 2nd, 4th, 6th week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
References:
citation: 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.