Rapid Antidepressant Effects of ATP and Phosphocreatine
- Registration Number
- NCT03138681
- Lead Sponsor
- Zhujiang Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - ATP ATP - phosphocreatine Phosphocreatine -
- Primary Outcome Measures
Name Time Method Changes in Hamilton depression rating scale during the first six weeks baseline, 1st, 2nd, 4th, 6th week
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Zhujiang Hospital
🇨🇳Guangzhou, Guangdong, China