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Last Updated: November 2, 2024

CLINICAL TRIALS PROFILE FOR PEXEVA


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All Clinical Trials for PEXEVA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01944657 ↗ Supplemental Transcranial Magnetic Stimulation (TMS) vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study Withdrawn Central Michigan University N/A 2013-09-01 A. Introduction to the Problem This field experiment is intended to explore whether supplemental transcranial magnetic stimulation (TMS) is more effective than standard medication mono-therapy for the treatment of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the practice guidelines of the American Psychiatric Association for the treatment of major depression. B. Importance of the Area of Study The safety, efficacy and value of TMS treatment has been established through the four-phase FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict enrollment and methodological requirements. TMS is now used in actual clinical practice and there is an opportunity to extend laboratory research and typical, highly controlled field settings to applied settings. This study is designed to gather data on safety, efficacy and utility of TMS as it is used in clinical practice. C. Need for Additional Research Efficacy and safety of these interventions have been scientifically established and meta-analyses of these studies underscore the efficacy and safety of two treatment interventions to be employed in this study: 1) standard medication monotherapy and 2) standard medication therapy supplemented with TMS. However, many authors conclude that depression can be difficult to treat and there is an ongoing need for additional research. Depression remains a major public health problem.
NCT01944657 ↗ Supplemental Transcranial Magnetic Stimulation (TMS) vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study Withdrawn Sheppard Pratt Health System N/A 2013-09-01 A. Introduction to the Problem This field experiment is intended to explore whether supplemental transcranial magnetic stimulation (TMS) is more effective than standard medication mono-therapy for the treatment of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the practice guidelines of the American Psychiatric Association for the treatment of major depression. B. Importance of the Area of Study The safety, efficacy and value of TMS treatment has been established through the four-phase FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict enrollment and methodological requirements. TMS is now used in actual clinical practice and there is an opportunity to extend laboratory research and typical, highly controlled field settings to applied settings. This study is designed to gather data on safety, efficacy and utility of TMS as it is used in clinical practice. C. Need for Additional Research Efficacy and safety of these interventions have been scientifically established and meta-analyses of these studies underscore the efficacy and safety of two treatment interventions to be employed in this study: 1) standard medication monotherapy and 2) standard medication therapy supplemented with TMS. However, many authors conclude that depression can be difficult to treat and there is an ongoing need for additional research. Depression remains a major public health problem.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PEXEVA

Condition Name

Condition Name for PEXEVA
Intervention Trials
1. Major Depressive Disorder. 1
1. Major Depressive Disorder 1
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Condition MeSH

Condition MeSH for PEXEVA
Intervention Trials
Depression 1
Depressive Disorder, Major 1
Depressive Disorder 1
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Clinical Trial Locations for PEXEVA

Trials by Country

Trials by Country for PEXEVA
Location Trials
United States 1
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Trials by US State

Trials by US State for PEXEVA
Location Trials
Maryland 1
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Clinical Trial Progress for PEXEVA

Clinical Trial Phase

Clinical Trial Phase for PEXEVA
Clinical Trial Phase Trials
N/A 1
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Clinical Trial Status

Clinical Trial Status for PEXEVA
Clinical Trial Phase Trials
Withdrawn 1
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Clinical Trial Sponsors for PEXEVA

Sponsor Name

Sponsor Name for PEXEVA
Sponsor Trials
Central Michigan University 1
Sheppard Pratt Health System 1
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Sponsor Type

Sponsor Type for PEXEVA
Sponsor Trials
Other 2
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