Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants
The novel mechanisms of action (MOA) derived from some recently introduced molecular targets have led to regulatory approvals for rapid acting antidepressants (RAADs) that can generate responses within hours or days, rather than weeks or months. These novel targets include the N-methyl-D-glutamate r...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-06-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1135828/full |
| _version_ | 1827935476782202880 |
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| author | Christian Yavorsky Elizabeth Ballard Mark Opler Jan Sedway Steven D. Targum William Lenderking |
| author_facet | Christian Yavorsky Elizabeth Ballard Mark Opler Jan Sedway Steven D. Targum William Lenderking |
| author_sort | Christian Yavorsky |
| collection | DOAJ |
| description | The novel mechanisms of action (MOA) derived from some recently introduced molecular targets have led to regulatory approvals for rapid acting antidepressants (RAADs) that can generate responses within hours or days, rather than weeks or months. These novel targets include the N-methyl-D-glutamate receptor antagonist ketamine, along with its enantiomers and various derivatives, and the allosteric modulators of gamma-aminobutyric acid (GABA) receptors. There has also been a strong resurgence in interest in psychedelic compounds that impact a range of receptor sites including D1, 5-HT7, KOR, 5-HT5A, Sigma-1, NMDA, and BDNF. The RAADs developed from these novel targets have enabled successful treatment for difficult to treat depressed individuals and has generated a new wave of innovation in research and treatment. Despite the advances in the neurobiology and clinical treatment of mood disorders, we are still using rating instruments that were created decades ago for drugs from a different era (e.g., The Hamilton and Montgomery-Åsberg depression rating scales, HDRS, and MADRS) continue to be used. These rating instruments were designed to assess mood symptoms over a 7-day time frame. Consequently, the use of these rating instruments often requires modifications to address items that cannot be assessed in short time frames, such as the sleep and appetite items. This review describes the adaptative approaches that have been made with the existing scales to meet this need and examines additional domains such as daily activities, side effects, suicidal ideation and behavior, and role functioning. Recommendations for future studies are described, including the challenges related to implementation of these adapted measures and approaches to mitigation. |
| first_indexed | 2024-03-13T07:55:22Z |
| format | Article |
| id | doaj.art-b0048f13eb43427aba89945beb0ca7ae |
| institution | Directory Open Access Journal |
| issn | 1664-0640 |
| language | English |
| last_indexed | 2024-03-13T07:55:22Z |
| publishDate | 2023-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj.art-b0048f13eb43427aba89945beb0ca7ae2023-06-02T06:08:17ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402023-06-011410.3389/fpsyt.2023.11358281135828Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressantsChristian Yavorsky0Elizabeth Ballard1Mark Opler2Jan Sedway3Steven D. Targum4William Lenderking5Valis Biosciences, Inc., Berkeley, CA, United StatesNIH/NIMH, Bethesda, MD, United StatesWIRB Copernicus Group (WCG) Clinical Endpoint Solutions, Princeton, NJ, United StatesWIRB Copernicus Group (WCG) Clinical Endpoint Solutions, Princeton, NJ, United StatesSignant Health, Blue Bell, PA, United StatesEvidera, Bethesda, MD, United StatesThe novel mechanisms of action (MOA) derived from some recently introduced molecular targets have led to regulatory approvals for rapid acting antidepressants (RAADs) that can generate responses within hours or days, rather than weeks or months. These novel targets include the N-methyl-D-glutamate receptor antagonist ketamine, along with its enantiomers and various derivatives, and the allosteric modulators of gamma-aminobutyric acid (GABA) receptors. There has also been a strong resurgence in interest in psychedelic compounds that impact a range of receptor sites including D1, 5-HT7, KOR, 5-HT5A, Sigma-1, NMDA, and BDNF. The RAADs developed from these novel targets have enabled successful treatment for difficult to treat depressed individuals and has generated a new wave of innovation in research and treatment. Despite the advances in the neurobiology and clinical treatment of mood disorders, we are still using rating instruments that were created decades ago for drugs from a different era (e.g., The Hamilton and Montgomery-Åsberg depression rating scales, HDRS, and MADRS) continue to be used. These rating instruments were designed to assess mood symptoms over a 7-day time frame. Consequently, the use of these rating instruments often requires modifications to address items that cannot be assessed in short time frames, such as the sleep and appetite items. This review describes the adaptative approaches that have been made with the existing scales to meet this need and examines additional domains such as daily activities, side effects, suicidal ideation and behavior, and role functioning. Recommendations for future studies are described, including the challenges related to implementation of these adapted measures and approaches to mitigation.https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1135828/fullrapid acting anti-depressantspsychometricsmeasurement of rapid response to anti-depressant treatmentISCTM working groupnovel anti-depressantsketamine |
| spellingShingle | Christian Yavorsky Elizabeth Ballard Mark Opler Jan Sedway Steven D. Targum William Lenderking Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants Frontiers in Psychiatry rapid acting anti-depressants psychometrics measurement of rapid response to anti-depressant treatment ISCTM working group novel anti-depressants ketamine |
| title | Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants |
| title_full | Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants |
| title_fullStr | Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants |
| title_full_unstemmed | Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants |
| title_short | Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants |
| title_sort | recommendations for selection and adaptation of rating scales for clinical studies of rapid acting antidepressants |
| topic | rapid acting anti-depressants psychometrics measurement of rapid response to anti-depressant treatment ISCTM working group novel anti-depressants ketamine |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1135828/full |
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