Rapid Antidepressant Effects of ATP and Phosphocreatine

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

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: ATP; Drug: Phosphocreatine

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lianxu Zhao, M.D.; Phone Number: 020-62783082; Email: zhaolianxu@smu.edu.cn
• Study Contact Backup: Name: Jianming Yang, M.D.; Phone Number: 020-62783082; Email: jimmyyoung@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Zhujiang Hospital
      • Contact: Lianxu Zhao, M.D.; Phone Number: 020-62783082; Email: zhaolianxu@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Protective Agents; Cardiotonic Agents; Phosphocreatine
• Other Study ID Numbers: 2017-SJNK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No