Major Depressive Disorder
Conditions
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.
Interventions
DRUGPlacebo
placebo is given intravenously twice a day for 14 days
DRUGATP
ATP (100mg) is given intravenously twice a day for 14 days
DRUGPhosphocreatine
Phosphocreatine (1g) is given intravenously twice a day for 14 days
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Hamilton depression rating scale during the first six weeks | baseline, 1st, 2nd, 4th, 6th week |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactLianxu Zhao, M.D.
Backup ContactJianming Yang, M.D.
Outcome results
None listed