Major Depressive DisorderPhase 2NCT03138681
Rapid Antidepressant Effects of ATP and Phosphocreatine
A Phase 2 study testing ATP and Phosphocreatine in people with Major Depressive Disorder, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ATP and Phosphocreatine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2017to 30 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510280
Lianxu Zhao, M.D., 020-62783082, zhaolianxu@smu.edu.cn
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Placebo, ATP, Phosphocreatine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo is given intravenously twice a day for 14 days
ATPDrug
ATP (100mg) is given intravenously twice a day for 14 days
PhosphocreatineDrug
Phosphocreatine (1g) is given intravenously twice a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| ATP | Experimental | Not described Receives: Drug: ATP |
| phosphocreatine | Experimental | Not described Receives: Drug: Phosphocreatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hamilton depression rating scale during the first six weeks
Measured: baseline, 1st, 2nd, 4th, 6th week
Secondary outcomes (3)
Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks
Measured: baseline, 1st, 2nd, 4th, 6th week
Changes in Clinical global impression scale during the study
Measured: baseline, 2nd, 4th, 10th week
Side effects assessment during the first six weeks
Measured: 1st, 2nd, 4th, 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start3 May 2017
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138681
- Sponsor's protocol ID
- 2017-SJNK-001
- Status last verified
- Apr 2017
- First submitted
- 24 Apr 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30626424
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Clinical Study on the Rapid Antidepressant Effects of Adenosine Triphosphate (ATP) and Phosphocreatine Combinated With Fluoxetine
- ClinicalTrials.gov ID
- NCT03138681
- Acronym / sponsor ID
- 2017-SJNK-001
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| ATP | Experimental | Drug: ATP |
| phosphocreatine | Experimental | Drug: Phosphocreatine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboplacebo is given intravenously twice a day for 14 days | Drug | Placebo |
| ATPATP (100mg) is given intravenously twice a day for 14 days | Drug | ATP |
| PhosphocreatinePhosphocreatine (1g) is given intravenously twice a day for 14 days | Drug | phosphocreatine |
Primary outcome
Changes in Hamilton depression rating scale during the first six weeks
Time frame: baseline, 1st, 2nd, 4th, 6th week
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 30626424Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATP and Phosphocreatine in people with Major Depressive Disorder, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lianxu Zhao, M.D. (020-62783082, zhaolianxu@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hamilton depression rating scale during the first six weeks (time frame: baseline, 1st, 2nd, 4th, 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.