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Rapid Antidepressant Effects of ATP and Phosphocreatine

Primary Purpose

Major Depressive Disorder

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Placebo

ATP

Phosphocreatine

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhujiang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ATP

phosphocreatine

Arm Description

Outcomes

Primary Outcome Measures

Changes in Hamilton depression rating scale during the first six weeks

Secondary Outcome Measures

Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks

Changes in Clinical global impression scale during the study

Side effects assessment during the first six weeks

Full Information

NCT ID

NCT03138681

First Posted

April 24, 2017

Last Updated

May 3, 2017

Sponsor

Zhujiang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03138681

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 3, 2017 (Actual)

Primary Completion Date

April 30, 2019 (Anticipated)

Study Completion Date

April 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

ATP

Arm Type

Experimental

Arm Title

phosphocreatine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo is given intravenously twice a day for 14 days

Intervention Type

Drug

Intervention Name(s)

ATP

Intervention Description

ATP (100mg) is given intravenously twice a day for 14 days

Intervention Type

Drug

Intervention Name(s)

Phosphocreatine

Intervention Description

Phosphocreatine (1g) is given intravenously twice a day for 14 days

Primary Outcome Measure Information:

Title

Changes in Hamilton depression rating scale during the first six weeks

Time Frame

baseline, 1st, 2nd, 4th, 6th week

Secondary Outcome Measure Information:

Title

Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks

Time Frame

baseline, 1st, 2nd, 4th, 6th week

Title

Changes in Clinical global impression scale during the study

Time Frame

baseline, 2nd, 4th, 10th week

Title

Side effects assessment during the first six weeks

Time Frame

1st, 2nd, 4th, 6th week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lianxu Zhao, M.D.

Phone

020-62783082

zhaolianxu@smu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jianming Yang, M.D.

Phone

020-62783082

jimmyyoung@smu.edu.cn

Facility Information:

Facility Name

Zhujiang Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510280

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lianxu Zhao, M.D.

Phone

020-62783082

zhaolianxu@smu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30626424

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.

Results Reference

derived

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Rapid Antidepressant Effects of ATP and Phosphocreatine

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