Rapid Antidepressant Effects of ATP and Phosphocreatine

NCT ID: NCT03138681

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-03

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo is given intravenously twice a day for 14 days

ATP

Group Type EXPERIMENTAL

ATP

Intervention Type DRUG

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

phosphocreatine

Group Type EXPERIMENTAL

Phosphocreatine

Intervention Type DRUG

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

Interventions

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Placebo

placebo is given intravenously twice a day for 14 days

Intervention Type DRUG

ATP

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

Intervention Type DRUG

Phosphocreatine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhujiang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lianxu Zhao, M.D.

Role: CONTACT

020-62783082

Jianming Yang, M.D.

Role: CONTACT

020-62783082

Facility Contacts

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Lianxu Zhao, M.D.

Role: primary

020-62783082

References

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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.

Reference Type DERIVED
PMID: 30626424 (View on PubMed)

Other Identifiers

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2017-SJNK-001

Identifier Type: -

Identifier Source: org_study_id

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