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Rapid Antidepressant Effects of ATP and Phosphocreatine

Sponsor
Zhujiang Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03138681
Collaborator
(none)
42
Enrollment
1
Location
3
Arms
23.9
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Preliminary Clinical Study on the Rapid Antidepressant Effects of Adenosine Triphosphate (ATP) and Phosphocreatine Combinated With Fluoxetine
Actual Study Start Date :
May 3, 2017
Anticipated Primary Completion Date :
Apr 30, 2019
Anticipated Study Completion Date :
Apr 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes in Hamilton depression rating scale during the first six weeks [baseline, 1st, 2nd, 4th, 6th week]

Secondary Outcome Measures

  1. Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks [baseline, 1st, 2nd, 4th, 6th week]

  2. Changes in Clinical global impression scale during the study [baseline, 2nd, 4th, 10th week]

  3. Side effects assessment during the first six weeks [1st, 2nd, 4th, 6th week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhujiang Hospital Guangzhou Guangdong China 510280

Sponsors and Collaborators

  • Zhujiang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhujiang Hospital
ClinicalTrials.gov Identifier:
NCT03138681
Other Study ID Numbers:
  • 2017-SJNK-001
First Posted:
May 3, 2017
Last Update Posted:
May 8, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Phosphocreatine

Study Results

No Results Posted as of May 8, 2017