Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study
Abstract Background Major depressive disorder (MDD) is a common psychiatric disorder. With systematic antidepressant treatment, 50–75% of patients have a treatment response but require 4–6 weeks to have their symptoms alleviated. Therefore, researchers anticipate the development of novel fast-acting...
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| Format: | Article |
| Language: | English |
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BMC
2019-01-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-3115-4 |
| _version_ | 1819049208304369664 |
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| author | Yiyi Chen Xiaomin Cao Wensi Zang Shanyong Tan Chun-quan Ou Xiaoyan Shen Tianming Gao Lianxu Zhao |
| author_facet | Yiyi Chen Xiaomin Cao Wensi Zang Shanyong Tan Chun-quan Ou Xiaoyan Shen Tianming Gao Lianxu Zhao |
| author_sort | Yiyi Chen |
| collection | DOAJ |
| description | Abstract Background Major depressive disorder (MDD) is a common psychiatric disorder. With systematic antidepressant treatment, 50–75% of patients have a treatment response but require 4–6 weeks to have their symptoms alleviated. Therefore, researchers anticipate the development of novel fast-acting antidepressants. Previous studies have revealed that the decrease of bio-energetic metabolism may contribute to the occurrence of depression, while our team has found adenosine triphosphate (ATP) and phosphocreatine (PCr) to be fast-acting antidepressants in the depressed-animal model. ATP and PCr have already been widely prescribed clinically as energy supplements for cells. This will be the first clinical attempt of the intravenous administration of ATP and PCr combined with orally administered fluoxetine in MDD. Methods This is a single-center, randomized, double-blind, placebo-controlled pilot study. A total of 42 patients will be divided randomly into three groups. Patients will receive an intravenous administration of ATP or PCr or saline twice daily combined with orally administered fluoxetine (20 mg/day) for the first 2 weeks and fluoxetine monotherapy for the following 4 weeks. Follow-up assessment will be completed at week 10. Feasibility outcomes will include percentages of patient eligibility, intention to use medication, willingness to participate, drug adherence, completion of the scheduled assessment, retention, drop-out, etc. Physical examination results, Side Effect Rating Scale, adverse events, results from blood tests, electroencephalogram, and electrocardiograph will be recorded for safety evaluation of the augmentation therapy. The trends of efficacy will be evaluated by the reduction rate of the Hamilton Depression Rating Scale, the mean change of the Clinical Global Impression Scale, and the Patients Health Questionaire-9 items. Discussion In our study, ATP and PCr will be given by intravenous infusion. Thus patients will be hospitalized for the initial 2 weeks for safety concern. Hospitalization will be an impact factor for the recruitment, participation, drop-out, efficacy, results, etc. The evaluation of our feasibility outcomes, study setting, safety of augmentation therapy and possible efficacy trends among groups, will facilitate a full-scale trial design and sample size calculation. Trial registration NCT03138681. Registered on 3 May 2017. First patient: 4 May 2017. |
| first_indexed | 2024-12-21T11:28:30Z |
| format | Article |
| id | doaj.art-5ef9c678a6ac4790825fc56d1c37aad9 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T11:28:30Z |
| publishDate | 2019-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-5ef9c678a6ac4790825fc56d1c37aad92022-12-21T19:05:37ZengBMCTrials1745-62152019-01-0120111110.1186/s13063-018-3115-4Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot studyYiyi Chen0Xiaomin Cao1Wensi Zang2Shanyong Tan3Chun-quan Ou4Xiaoyan Shen5Tianming Gao6Lianxu Zhao7Department of Neurology, Zhujiang Hospital, Southern Medical UniversityDepartment of Neurology, Zhujiang Hospital, Southern Medical UniversityDepartment of Neurobiology, School of Basic Medical Sciences, Southern Medical UniversityDepartment of Neurology, Zhujiang Hospital, Southern Medical UniversityState Key Laboratory of Organ Failure Research, Department of Biostatistics, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical UniversityDepartment of Neurology, Zhujiang Hospital, Southern Medical UniversityDepartment of Neurobiology, School of Basic Medical Sciences, Southern Medical UniversityDepartment of Neurology, Shenzhen Hospital, Southern Medical UniversityAbstract Background Major depressive disorder (MDD) is a common psychiatric disorder. With systematic antidepressant treatment, 50–75% of patients have a treatment response but require 4–6 weeks to have their symptoms alleviated. Therefore, researchers anticipate the development of novel fast-acting antidepressants. Previous studies have revealed that the decrease of bio-energetic metabolism may contribute to the occurrence of depression, while our team has found adenosine triphosphate (ATP) and phosphocreatine (PCr) to be fast-acting antidepressants in the depressed-animal model. ATP and PCr have already been widely prescribed clinically as energy supplements for cells. This will be the first clinical attempt of the intravenous administration of ATP and PCr combined with orally administered fluoxetine in MDD. Methods This is a single-center, randomized, double-blind, placebo-controlled pilot study. A total of 42 patients will be divided randomly into three groups. Patients will receive an intravenous administration of ATP or PCr or saline twice daily combined with orally administered fluoxetine (20 mg/day) for the first 2 weeks and fluoxetine monotherapy for the following 4 weeks. Follow-up assessment will be completed at week 10. Feasibility outcomes will include percentages of patient eligibility, intention to use medication, willingness to participate, drug adherence, completion of the scheduled assessment, retention, drop-out, etc. Physical examination results, Side Effect Rating Scale, adverse events, results from blood tests, electroencephalogram, and electrocardiograph will be recorded for safety evaluation of the augmentation therapy. The trends of efficacy will be evaluated by the reduction rate of the Hamilton Depression Rating Scale, the mean change of the Clinical Global Impression Scale, and the Patients Health Questionaire-9 items. Discussion In our study, ATP and PCr will be given by intravenous infusion. Thus patients will be hospitalized for the initial 2 weeks for safety concern. Hospitalization will be an impact factor for the recruitment, participation, drop-out, efficacy, results, etc. The evaluation of our feasibility outcomes, study setting, safety of augmentation therapy and possible efficacy trends among groups, will facilitate a full-scale trial design and sample size calculation. Trial registration NCT03138681. Registered on 3 May 2017. First patient: 4 May 2017.http://link.springer.com/article/10.1186/s13063-018-3115-4Major depressive disorderAdenosine triphosphatePhosphocreatineFluoxetineFast-acting antidepressantRandomized controlled trial |
| spellingShingle | Yiyi Chen Xiaomin Cao Wensi Zang Shanyong Tan Chun-quan Ou Xiaoyan Shen Tianming Gao Lianxu Zhao 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 Major depressive disorder Adenosine triphosphate Phosphocreatine Fluoxetine Fast-acting antidepressant Randomized controlled trial |
| title | Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study |
| title_full | Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study |
| title_fullStr | Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study |
| title_full_unstemmed | Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study |
| title_short | Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study |
| title_sort | intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder protocol for a randomized double blind placebo controlled pilot study |
| topic | Major depressive disorder Adenosine triphosphate Phosphocreatine Fluoxetine Fast-acting antidepressant Randomized controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-018-3115-4 |
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