The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder
Background: Intranasal esketamine demonstrates rapid improvement of depressive symptoms. However, transient adverse effects (dissociation, sedation and dizziness) may occur, which could impact driving performance. Aims: To evaluate the effects of 84 mg intranasal esketamine on driving performance in...
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| Veröffentlicht in: | Journal of psychopharmacology (Oxford) 2022-05, Vol.36 (5), p.614-625 |
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| creator | Dijkstra, Francis M van de Loo, Aurora JAE Abdulahad, Smedra Bosma, Else R Hartog, Mitch Huls, Hendrikje Kuijper, Dianne C de Vries, Esther Solanki, Bhavna Singh, Jaskaran Aluisio, Leah Zannikos, Peter Stuurman, Frederik E Jacobs, Gabriël E Verster, Joris C |
| description | Background:
Intranasal esketamine demonstrates rapid improvement of depressive symptoms. However, transient adverse effects (dissociation, sedation and dizziness) may occur, which could impact driving performance.
Aims:
To evaluate the effects of 84 mg intranasal esketamine on driving performance in unipolar major depressive disorder (MDD) or persistent depressive disorder (PDD) patients.
Methods:
The study consisted of two parts. Part A was a single-blind, double-dummy, randomized three-period, cross-over study to compare effects of esketamine versus placebo on next morning driving, 18 ± 2 h post-treatment. Alcohol was administered to demonstrate assay sensitivity. In Part B, same-day driving, 6 ± 0.5 hours post-treatment, was assessed during twice weekly esketamine administration for 3 weeks. Twenty-seven patients with mild-to-moderate MDD or PDD without psychotic features completed a 100 km on-the-road driving test on a public highway in normal traffic. The primary outcome was standard deviation of lateral position (SDLP; cm; weaving of car).
Results:
In Part A, alcohol impaired driving performance compared to placebo: Least-square means (95% CI), p-value for delta SDLP (cm) compared with placebo: (ΔSDLP = + 1.83 (1.03; 2.62), p |
| doi_str_mv | 10.1177/02698811221078764 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9112620</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_02698811221078764</sage_id><sourcerecordid>2665044544</sourcerecordid><originalsourceid>FETCH-LOGICAL-c466t-3545a251ddd80703dfabf21076acecde96d3911ec3f1ea1c4dedaa4dd672125d3</originalsourceid><addsrcrecordid>eNp1kc2KFDEUhYMoTjv6AG4k4MZNjfmv6o0gg6PCgJtxHe4kt7rTViVlUt2Db-EjT4oex38IBHK_c5KTQ8hzzs44b9vXTJh113EuBGdt1xr1gKy4MrxpRacfktUybxbghDwpZccYN8rox-REalFFUq_I96stUux7dHOhqachzhkiFBgoli84wxgi0hTranICT30OhxA3dMLcpzxCdFhFdII5YKweN2He0hF2KVOPU8ZSwgGpDyVlj5nW46osocyV_hfxlDzqYSj47G4_JZ8v3l2df2guP73_eP72snHKmLmRWmkQmnvvO9Yy6Xu47pdvMODQeVwbL9eco5M9R-BOefQAynvT1ujay1Py5ug77a9H9A6X4IOdchghf7MJgv19EsPWbtLBVldhBKsGr-4Mcvq6xzLbMRSHwwAR075YYaTsNJdqXdGXf6C7tM-xxquU0UwprVSl-JFyOZWSsb9_DGd26dv-1XfVvPg1xb3iR8EVODsCBTb489r_O94Csvi3yQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2665044544</pqid></control><display><type>article</type><title>The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder</title><source>MEDLINE</source><source>SAGE Complete</source><creator>Dijkstra, Francis M ; van de Loo, Aurora JAE ; Abdulahad, Smedra ; Bosma, Else R ; Hartog, Mitch ; Huls, Hendrikje ; Kuijper, Dianne C ; de Vries, Esther ; Solanki, Bhavna ; Singh, Jaskaran ; Aluisio, Leah ; Zannikos, Peter ; Stuurman, Frederik E ; Jacobs, Gabriël E ; Verster, Joris C</creator><creatorcontrib>Dijkstra, Francis M ; van de Loo, Aurora JAE ; Abdulahad, Smedra ; Bosma, Else R ; Hartog, Mitch ; Huls, Hendrikje ; Kuijper, Dianne C ; de Vries, Esther ; Solanki, Bhavna ; Singh, Jaskaran ; Aluisio, Leah ; Zannikos, Peter ; Stuurman, Frederik E ; Jacobs, Gabriël E ; Verster, Joris C</creatorcontrib><description>Background:
Intranasal esketamine demonstrates rapid improvement of depressive symptoms. However, transient adverse effects (dissociation, sedation and dizziness) may occur, which could impact driving performance.
Aims:
To evaluate the effects of 84 mg intranasal esketamine on driving performance in unipolar major depressive disorder (MDD) or persistent depressive disorder (PDD) patients.
Methods:
The study consisted of two parts. Part A was a single-blind, double-dummy, randomized three-period, cross-over study to compare effects of esketamine versus placebo on next morning driving, 18 ± 2 h post-treatment. Alcohol was administered to demonstrate assay sensitivity. In Part B, same-day driving, 6 ± 0.5 hours post-treatment, was assessed during twice weekly esketamine administration for 3 weeks. Twenty-seven patients with mild-to-moderate MDD or PDD without psychotic features completed a 100 km on-the-road driving test on a public highway in normal traffic. The primary outcome was standard deviation of lateral position (SDLP; cm; weaving of car).
Results:
In Part A, alcohol impaired driving performance compared to placebo: Least-square means (95% CI), p-value for delta SDLP (cm) compared with placebo: (ΔSDLP = + 1.83 (1.03; 2.62), p < 0.001), whereas esketamine did not: (ΔSDLP = −0.23 (−1.04; 0.58), p = 0.572). In Part B, weekly driving tests showed no differences between placebo baseline SDLP and after esketamine administration over 3 weeks: Day 11: (ΔSDLP = −0.96 (−3.72; 1.81), p = 0.493), Day 18: (ΔSDLP = −0.56 (−3.33; 2.20), p = 0.686) and Day 25: (ΔSDLP = −1.05 (−3.82; 1.71), p = 0.451).
Conclusions:
In this study, esketamine did not impair on-road driving performance the next morning following a single dose, or on same day after repeated administration.</description><identifier>ISSN: 0269-8811</identifier><identifier>EISSN: 1461-7285</identifier><identifier>DOI: 10.1177/02698811221078764</identifier><identifier>PMID: 35212235</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Antidepressants ; Antidepressive Agents - adverse effects ; Automobile Driving ; Cross-Over Studies ; Depressive Disorder, Major - drug therapy ; Double-Blind Method ; Driving ability ; Humans ; Ketamine ; Mental depression ; Original Papers ; Patients ; Placebos ; Psychomotor Performance ; Single-Blind Method</subject><ispartof>Journal of psychopharmacology (Oxford), 2022-05, Vol.36 (5), p.614-625</ispartof><rights>The Author(s) 2022</rights><rights>The Author(s) 2022 2022 British Association for Psychopharmacology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c466t-3545a251ddd80703dfabf21076acecde96d3911ec3f1ea1c4dedaa4dd672125d3</citedby><cites>FETCH-LOGICAL-c466t-3545a251ddd80703dfabf21076acecde96d3911ec3f1ea1c4dedaa4dd672125d3</cites><orcidid>0000-0002-0013-8355 ; 0000-0001-5804-0708 ; 0000-0002-6455-2096</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/02698811221078764$$EPDF$$P50$$Gsage$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/02698811221078764$$EHTML$$P50$$Gsage$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,21798,27901,27902,43597,43598</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35212235$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dijkstra, Francis M</creatorcontrib><creatorcontrib>van de Loo, Aurora JAE</creatorcontrib><creatorcontrib>Abdulahad, Smedra</creatorcontrib><creatorcontrib>Bosma, Else R</creatorcontrib><creatorcontrib>Hartog, Mitch</creatorcontrib><creatorcontrib>Huls, Hendrikje</creatorcontrib><creatorcontrib>Kuijper, Dianne C</creatorcontrib><creatorcontrib>de Vries, Esther</creatorcontrib><creatorcontrib>Solanki, Bhavna</creatorcontrib><creatorcontrib>Singh, Jaskaran</creatorcontrib><creatorcontrib>Aluisio, Leah</creatorcontrib><creatorcontrib>Zannikos, Peter</creatorcontrib><creatorcontrib>Stuurman, Frederik E</creatorcontrib><creatorcontrib>Jacobs, Gabriël E</creatorcontrib><creatorcontrib>Verster, Joris C</creatorcontrib><title>The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder</title><title>Journal of psychopharmacology (Oxford)</title><addtitle>J Psychopharmacol</addtitle><description>Background:
Intranasal esketamine demonstrates rapid improvement of depressive symptoms. However, transient adverse effects (dissociation, sedation and dizziness) may occur, which could impact driving performance.
Aims:
To evaluate the effects of 84 mg intranasal esketamine on driving performance in unipolar major depressive disorder (MDD) or persistent depressive disorder (PDD) patients.
Methods:
The study consisted of two parts. Part A was a single-blind, double-dummy, randomized three-period, cross-over study to compare effects of esketamine versus placebo on next morning driving, 18 ± 2 h post-treatment. Alcohol was administered to demonstrate assay sensitivity. In Part B, same-day driving, 6 ± 0.5 hours post-treatment, was assessed during twice weekly esketamine administration for 3 weeks. Twenty-seven patients with mild-to-moderate MDD or PDD without psychotic features completed a 100 km on-the-road driving test on a public highway in normal traffic. The primary outcome was standard deviation of lateral position (SDLP; cm; weaving of car).
Results:
In Part A, alcohol impaired driving performance compared to placebo: Least-square means (95% CI), p-value for delta SDLP (cm) compared with placebo: (ΔSDLP = + 1.83 (1.03; 2.62), p < 0.001), whereas esketamine did not: (ΔSDLP = −0.23 (−1.04; 0.58), p = 0.572). In Part B, weekly driving tests showed no differences between placebo baseline SDLP and after esketamine administration over 3 weeks: Day 11: (ΔSDLP = −0.96 (−3.72; 1.81), p = 0.493), Day 18: (ΔSDLP = −0.56 (−3.33; 2.20), p = 0.686) and Day 25: (ΔSDLP = −1.05 (−3.82; 1.71), p = 0.451).
Conclusions:
In this study, esketamine did not impair on-road driving performance the next morning following a single dose, or on same day after repeated administration.</description><subject>Antidepressants</subject><subject>Antidepressive Agents - adverse effects</subject><subject>Automobile Driving</subject><subject>Cross-Over Studies</subject><subject>Depressive Disorder, Major - drug therapy</subject><subject>Double-Blind Method</subject><subject>Driving ability</subject><subject>Humans</subject><subject>Ketamine</subject><subject>Mental depression</subject><subject>Original Papers</subject><subject>Patients</subject><subject>Placebos</subject><subject>Psychomotor Performance</subject><subject>Single-Blind Method</subject><issn>0269-8811</issn><issn>1461-7285</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>AFRWT</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc2KFDEUhYMoTjv6AG4k4MZNjfmv6o0gg6PCgJtxHe4kt7rTViVlUt2Db-EjT4oex38IBHK_c5KTQ8hzzs44b9vXTJh113EuBGdt1xr1gKy4MrxpRacfktUybxbghDwpZccYN8rox-REalFFUq_I96stUux7dHOhqachzhkiFBgoli84wxgi0hTranICT30OhxA3dMLcpzxCdFhFdII5YKweN2He0hF2KVOPU8ZSwgGpDyVlj5nW46osocyV_hfxlDzqYSj47G4_JZ8v3l2df2guP73_eP72snHKmLmRWmkQmnvvO9Yy6Xu47pdvMODQeVwbL9eco5M9R-BOefQAynvT1ujay1Py5ug77a9H9A6X4IOdchghf7MJgv19EsPWbtLBVldhBKsGr-4Mcvq6xzLbMRSHwwAR075YYaTsNJdqXdGXf6C7tM-xxquU0UwprVSl-JFyOZWSsb9_DGd26dv-1XfVvPg1xb3iR8EVODsCBTb489r_O94Csvi3yQ</recordid><startdate>20220501</startdate><enddate>20220501</enddate><creator>Dijkstra, Francis M</creator><creator>van de Loo, Aurora JAE</creator><creator>Abdulahad, Smedra</creator><creator>Bosma, Else R</creator><creator>Hartog, Mitch</creator><creator>Huls, Hendrikje</creator><creator>Kuijper, Dianne C</creator><creator>de Vries, Esther</creator><creator>Solanki, Bhavna</creator><creator>Singh, Jaskaran</creator><creator>Aluisio, Leah</creator><creator>Zannikos, Peter</creator><creator>Stuurman, Frederik E</creator><creator>Jacobs, Gabriël E</creator><creator>Verster, Joris C</creator><general>SAGE Publications</general><general>Sage Publications Ltd</general><scope>AFRWT</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-0013-8355</orcidid><orcidid>https://orcid.org/0000-0001-5804-0708</orcidid><orcidid>https://orcid.org/0000-0002-6455-2096</orcidid></search><sort><creationdate>20220501</creationdate><title>The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder</title><author>Dijkstra, Francis M ; van de Loo, Aurora JAE ; Abdulahad, Smedra ; Bosma, Else R ; Hartog, Mitch ; Huls, Hendrikje ; Kuijper, Dianne C ; de Vries, Esther ; Solanki, Bhavna ; Singh, Jaskaran ; Aluisio, Leah ; Zannikos, Peter ; Stuurman, Frederik E ; Jacobs, Gabriël E ; Verster, Joris C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c466t-3545a251ddd80703dfabf21076acecde96d3911ec3f1ea1c4dedaa4dd672125d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Antidepressants</topic><topic>Antidepressive Agents - adverse effects</topic><topic>Automobile Driving</topic><topic>Cross-Over Studies</topic><topic>Depressive Disorder, Major - drug therapy</topic><topic>Double-Blind Method</topic><topic>Driving ability</topic><topic>Humans</topic><topic>Ketamine</topic><topic>Mental depression</topic><topic>Original Papers</topic><topic>Patients</topic><topic>Placebos</topic><topic>Psychomotor Performance</topic><topic>Single-Blind Method</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dijkstra, Francis M</creatorcontrib><creatorcontrib>van de Loo, Aurora JAE</creatorcontrib><creatorcontrib>Abdulahad, Smedra</creatorcontrib><creatorcontrib>Bosma, Else R</creatorcontrib><creatorcontrib>Hartog, Mitch</creatorcontrib><creatorcontrib>Huls, Hendrikje</creatorcontrib><creatorcontrib>Kuijper, Dianne C</creatorcontrib><creatorcontrib>de Vries, Esther</creatorcontrib><creatorcontrib>Solanki, Bhavna</creatorcontrib><creatorcontrib>Singh, Jaskaran</creatorcontrib><creatorcontrib>Aluisio, Leah</creatorcontrib><creatorcontrib>Zannikos, Peter</creatorcontrib><creatorcontrib>Stuurman, Frederik E</creatorcontrib><creatorcontrib>Jacobs, Gabriël E</creatorcontrib><creatorcontrib>Verster, Joris C</creatorcontrib><collection>SAGE Open Access Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of psychopharmacology (Oxford)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dijkstra, Francis M</au><au>van de Loo, Aurora JAE</au><au>Abdulahad, Smedra</au><au>Bosma, Else R</au><au>Hartog, Mitch</au><au>Huls, Hendrikje</au><au>Kuijper, Dianne C</au><au>de Vries, Esther</au><au>Solanki, Bhavna</au><au>Singh, Jaskaran</au><au>Aluisio, Leah</au><au>Zannikos, Peter</au><au>Stuurman, Frederik E</au><au>Jacobs, Gabriël E</au><au>Verster, Joris C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder</atitle><jtitle>Journal of psychopharmacology (Oxford)</jtitle><addtitle>J Psychopharmacol</addtitle><date>2022-05-01</date><risdate>2022</risdate><volume>36</volume><issue>5</issue><spage>614</spage><epage>625</epage><pages>614-625</pages><issn>0269-8811</issn><eissn>1461-7285</eissn><abstract>Background:
Intranasal esketamine demonstrates rapid improvement of depressive symptoms. However, transient adverse effects (dissociation, sedation and dizziness) may occur, which could impact driving performance.
Aims:
To evaluate the effects of 84 mg intranasal esketamine on driving performance in unipolar major depressive disorder (MDD) or persistent depressive disorder (PDD) patients.
Methods:
The study consisted of two parts. Part A was a single-blind, double-dummy, randomized three-period, cross-over study to compare effects of esketamine versus placebo on next morning driving, 18 ± 2 h post-treatment. Alcohol was administered to demonstrate assay sensitivity. In Part B, same-day driving, 6 ± 0.5 hours post-treatment, was assessed during twice weekly esketamine administration for 3 weeks. Twenty-seven patients with mild-to-moderate MDD or PDD without psychotic features completed a 100 km on-the-road driving test on a public highway in normal traffic. The primary outcome was standard deviation of lateral position (SDLP; cm; weaving of car).
Results:
In Part A, alcohol impaired driving performance compared to placebo: Least-square means (95% CI), p-value for delta SDLP (cm) compared with placebo: (ΔSDLP = + 1.83 (1.03; 2.62), p < 0.001), whereas esketamine did not: (ΔSDLP = −0.23 (−1.04; 0.58), p = 0.572). In Part B, weekly driving tests showed no differences between placebo baseline SDLP and after esketamine administration over 3 weeks: Day 11: (ΔSDLP = −0.96 (−3.72; 1.81), p = 0.493), Day 18: (ΔSDLP = −0.56 (−3.33; 2.20), p = 0.686) and Day 25: (ΔSDLP = −1.05 (−3.82; 1.71), p = 0.451).
Conclusions:
In this study, esketamine did not impair on-road driving performance the next morning following a single dose, or on same day after repeated administration.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>35212235</pmid><doi>10.1177/02698811221078764</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0002-0013-8355</orcidid><orcidid>https://orcid.org/0000-0001-5804-0708</orcidid><orcidid>https://orcid.org/0000-0002-6455-2096</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0269-8811 |
| ispartof | Journal of psychopharmacology (Oxford), 2022-05, Vol.36 (5), p.614-625 |
| issn | 0269-8811 1461-7285 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9112620 |
| source | MEDLINE; SAGE Complete |
| subjects | Antidepressants Antidepressive Agents - adverse effects Automobile Driving Cross-Over Studies Depressive Disorder, Major - drug therapy Double-Blind Method Driving ability Humans Ketamine Mental depression Original Papers Patients Placebos Psychomotor Performance Single-Blind Method |
| title | The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder |
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