Rapid Antidepressant Effects of ATP and Phosphocreatine

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2019

Interventions

  • Drug: Placebo
    • placebo is given intravenously twice a day for 14 days
  • Drug: ATP
    • ATP (100mg) is given intravenously twice a day for 14 days
  • Drug: Phosphocreatine
    • Phosphocreatine (1g) is given intravenously twice a day for 14 days

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: ATP
  • Experimental: phosphocreatine

Clinical Trial Outcome Measures

Primary Measures

  • Changes in Hamilton depression rating scale during the first six weeks
    • Time Frame: baseline, 1st, 2nd, 4th, 6th week

Secondary Measures

  • Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks
    • Time Frame: baseline, 1st, 2nd, 4th, 6th week
  • Changes in Clinical global impression scale during the study
    • Time Frame: baseline, 2nd, 4th, 10th week
  • Side effects assessment during the first six weeks
    • Time Frame: 1st, 2nd, 4th, 6th week

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhujiang Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Lianxu Zhao, M.D., 020-62783082, zhaolianxu@smu.edu.cn

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