Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study
Objective:Low-dose testosterone has been shown to improve depression symptom severity, fatigue, and sexual function in small studies in women not formally diagnosed with major depressive disorder. The authors sought to determine whether adjunctive low-dose transdermal testosterone improves depressio...
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| Veröffentlicht in: | The American journal of psychiatry 2020-10, Vol.177 (10), p.965-973 |
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| creator | Dichtel, Laura E Carpenter, Linda L Nyer, Maren Mischoulon, David Kimball, Allison Deckersbach, Thilo Dougherty, Darin D Schoenfeld, David A Fisher, Lauren Cusin, Cristina Dording, Christina Trinh, Nhi-Ha Pedrelli, Paola Yeung, Albert Farabaugh, Amy Papakostas, George I Chang, Trina Shapero, Benjamin G Chen, Justin Cassano, Paolo Hahn, Emily M Rao, Elizabeth M Brady, Roscoe O Singh, Ravinder J Tyrka, Audrey R Price, Lawrence H Fava, Maurizio Miller, Karen K |
| description | Objective:Low-dose testosterone has been shown to improve depression symptom severity, fatigue, and sexual function in small studies in women not formally diagnosed with major depressive disorder. The authors sought to determine whether adjunctive low-dose transdermal testosterone improves depression symptom severity, fatigue, and sexual function in women with antidepressant-resistant major depression. A functional MRI (fMRI) substudy examined effects on activity in the anterior cingulate cortex (ACC), a brain region important in mood regulation.Methods:The authors conducted an 8-week randomized double-blind placebo-controlled trial of adjunctive testosterone cream in 101 women, ages 21–70, with antidepressant-resistant major depression. The primary outcome measure was depression symptom severity as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary endpoints included fatigue, sexual function, and safety measures. The primary outcome of the fMRI substudy (N=20) was change in ACC activity.Results:The participants’ mean age was 47 years (SD=14) and their mean baseline MADRS score was 26.6 (SD=5.9). Eighty-seven (86%) participants completed 8 weeks of treatment. MADRS scores decreased in both study arms from baseline to week 8 (testosterone arm: from 26.8 [SD=6.3] to 15.3 [SD=9.6]; placebo arm: from 26.3 [SD=5.4] to 14.4 [SD=9.3]), with no significant difference between groups. Improvement in fatigue and sexual function did not differ between groups, nor did side effects. fMRI results showed a relationship between ACC activation and androgen levels before treatment but no difference in ACC activation with testosterone compared with placebo.Conclusions:Adjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction. Imaging in a subset of participants demonstrated that testosterone did not result in greater activation of the ACC. |
| doi_str_mv | 10.1176/appi.ajp.2020.19080844 |
| format | Article |
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The authors sought to determine whether adjunctive low-dose transdermal testosterone improves depression symptom severity, fatigue, and sexual function in women with antidepressant-resistant major depression. A functional MRI (fMRI) substudy examined effects on activity in the anterior cingulate cortex (ACC), a brain region important in mood regulation.Methods:The authors conducted an 8-week randomized double-blind placebo-controlled trial of adjunctive testosterone cream in 101 women, ages 21–70, with antidepressant-resistant major depression. The primary outcome measure was depression symptom severity as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary endpoints included fatigue, sexual function, and safety measures. The primary outcome of the fMRI substudy (N=20) was change in ACC activity.Results:The participants’ mean age was 47 years (SD=14) and their mean baseline MADRS score was 26.6 (SD=5.9). Eighty-seven (86%) participants completed 8 weeks of treatment. MADRS scores decreased in both study arms from baseline to week 8 (testosterone arm: from 26.8 [SD=6.3] to 15.3 [SD=9.6]; placebo arm: from 26.3 [SD=5.4] to 14.4 [SD=9.3]), with no significant difference between groups. Improvement in fatigue and sexual function did not differ between groups, nor did side effects. fMRI results showed a relationship between ACC activation and androgen levels before treatment but no difference in ACC activation with testosterone compared with placebo.Conclusions:Adjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction. Imaging in a subset of participants demonstrated that testosterone did not result in greater activation of the ACC.</description><identifier>ISSN: 0002-953X</identifier><identifier>EISSN: 1535-7228</identifier><identifier>DOI: 10.1176/appi.ajp.2020.19080844</identifier><identifier>PMID: 32660299</identifier><language>eng</language><publisher>United States: American Psychiatric Association</publisher><subject>Adult ; Aged ; Antidepressants ; Depressive Disorder, Major - diagnostic imaging ; Depressive Disorder, Major - drug therapy ; Depressive Disorder, Treatment-Resistant - diagnostic imaging ; Depressive Disorder, Treatment-Resistant - drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Functional Neuroimaging ; Gyrus Cinguli - diagnostic imaging ; Humans ; Hydrocortisone - blood ; Magnetic Resonance Imaging ; Mental depression ; Middle Aged ; Placebo effect ; Skin Cream ; Testosterone ; Testosterone - administration & dosage ; Testosterone - blood ; Testosterone - therapeutic use ; Young Adult</subject><ispartof>The American journal of psychiatry, 2020-10, Vol.177 (10), p.965-973</ispartof><rights>Copyright © 2020 by the American Psychiatric Association 2020</rights><rights>Copyright American Psychiatric Association Oct 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a431t-61f54b57692ec36fc0058ddfe74ca6a4efee37cb4901b38e09d38964dbfd4b873</citedby><cites>FETCH-LOGICAL-a431t-61f54b57692ec36fc0058ddfe74ca6a4efee37cb4901b38e09d38964dbfd4b873</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://psychiatryonline.org/doi/epdf/10.1176/appi.ajp.2020.19080844$$EPDF$$P50$$Gappi$$H</linktopdf><linktohtml>$$Uhttps://psychiatryonline.org/doi/full/10.1176/appi.ajp.2020.19080844$$EHTML$$P50$$Gappi$$H</linktohtml><link.rule.ids>314,780,784,2855,21626,21627,21628,27924,27925,77794,77799</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32660299$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dichtel, Laura E</creatorcontrib><creatorcontrib>Carpenter, Linda L</creatorcontrib><creatorcontrib>Nyer, Maren</creatorcontrib><creatorcontrib>Mischoulon, David</creatorcontrib><creatorcontrib>Kimball, Allison</creatorcontrib><creatorcontrib>Deckersbach, Thilo</creatorcontrib><creatorcontrib>Dougherty, Darin D</creatorcontrib><creatorcontrib>Schoenfeld, David A</creatorcontrib><creatorcontrib>Fisher, Lauren</creatorcontrib><creatorcontrib>Cusin, Cristina</creatorcontrib><creatorcontrib>Dording, Christina</creatorcontrib><creatorcontrib>Trinh, Nhi-Ha</creatorcontrib><creatorcontrib>Pedrelli, Paola</creatorcontrib><creatorcontrib>Yeung, Albert</creatorcontrib><creatorcontrib>Farabaugh, Amy</creatorcontrib><creatorcontrib>Papakostas, George I</creatorcontrib><creatorcontrib>Chang, Trina</creatorcontrib><creatorcontrib>Shapero, Benjamin G</creatorcontrib><creatorcontrib>Chen, Justin</creatorcontrib><creatorcontrib>Cassano, Paolo</creatorcontrib><creatorcontrib>Hahn, Emily M</creatorcontrib><creatorcontrib>Rao, Elizabeth M</creatorcontrib><creatorcontrib>Brady, Roscoe O</creatorcontrib><creatorcontrib>Singh, Ravinder J</creatorcontrib><creatorcontrib>Tyrka, Audrey R</creatorcontrib><creatorcontrib>Price, Lawrence H</creatorcontrib><creatorcontrib>Fava, Maurizio</creatorcontrib><creatorcontrib>Miller, Karen K</creatorcontrib><title>Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study</title><title>The American journal of psychiatry</title><addtitle>Am J Psychiatry</addtitle><description>Objective:Low-dose testosterone has been shown to improve depression symptom severity, fatigue, and sexual function in small studies in women not formally diagnosed with major depressive disorder. The authors sought to determine whether adjunctive low-dose transdermal testosterone improves depression symptom severity, fatigue, and sexual function in women with antidepressant-resistant major depression. A functional MRI (fMRI) substudy examined effects on activity in the anterior cingulate cortex (ACC), a brain region important in mood regulation.Methods:The authors conducted an 8-week randomized double-blind placebo-controlled trial of adjunctive testosterone cream in 101 women, ages 21–70, with antidepressant-resistant major depression. The primary outcome measure was depression symptom severity as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary endpoints included fatigue, sexual function, and safety measures. The primary outcome of the fMRI substudy (N=20) was change in ACC activity.Results:The participants’ mean age was 47 years (SD=14) and their mean baseline MADRS score was 26.6 (SD=5.9). Eighty-seven (86%) participants completed 8 weeks of treatment. MADRS scores decreased in both study arms from baseline to week 8 (testosterone arm: from 26.8 [SD=6.3] to 15.3 [SD=9.6]; placebo arm: from 26.3 [SD=5.4] to 14.4 [SD=9.3]), with no significant difference between groups. Improvement in fatigue and sexual function did not differ between groups, nor did side effects. fMRI results showed a relationship between ACC activation and androgen levels before treatment but no difference in ACC activation with testosterone compared with placebo.Conclusions:Adjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction. Imaging in a subset of participants demonstrated that testosterone did not result in greater activation of the ACC.</description><subject>Adult</subject><subject>Aged</subject><subject>Antidepressants</subject><subject>Depressive Disorder, Major - diagnostic imaging</subject><subject>Depressive Disorder, Major - drug therapy</subject><subject>Depressive Disorder, Treatment-Resistant - diagnostic imaging</subject><subject>Depressive Disorder, Treatment-Resistant - drug therapy</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Functional Neuroimaging</subject><subject>Gyrus Cinguli - diagnostic imaging</subject><subject>Humans</subject><subject>Hydrocortisone - blood</subject><subject>Magnetic Resonance Imaging</subject><subject>Mental depression</subject><subject>Middle Aged</subject><subject>Placebo effect</subject><subject>Skin Cream</subject><subject>Testosterone</subject><subject>Testosterone - administration & dosage</subject><subject>Testosterone - blood</subject><subject>Testosterone - therapeutic use</subject><subject>Young Adult</subject><issn>0002-953X</issn><issn>1535-7228</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc1u1DAURi1ERaeFV6gssWGTqf_ixOxGM1AqDSoqRWUXOfEN8pDYqe2AylvwxniYtgs2rGzfe-5nWwehM0qWlFbyXE-TXerdtGSE5ZIiNamFeIYWtORlUTFWP0cLQggrVMm_HqOTGHf5SHjFXqBjzqQkTKkF-r31P4uNj4BvICYfEwTvAK_mbyO4pJP1Dvc-4JVL1sAUIEbtUnEN0caUd_ij3uX25tCyPwBvbPTBQMDW4VufU97mYVwXtwDf8bV2xo_2Fxj8adAdtL5Ye5eCH4Zc-pxmc_8SHfV6iPDqYT1FX96_u1l_KLZXF5fr1bbQgtNUSNqXoi0rqRh0XPYdIWVtTA-V6LTUAnoAXnWtUIS2vAaiDK-VFKbtjWjrip-iN4fcKfi7OX--GW3sYBi0Az_HhgnGa8IVVRl9_Q-683Nw-XWZkoSSSgieKXmguuBjDNA3U7CjDvcNJc1eWrOX1mRpzV5a8ygtD549xM_tCOZp7NFSBvgB-BvwdPd_Yv8AI4enYw</recordid><startdate>20201001</startdate><enddate>20201001</enddate><creator>Dichtel, Laura E</creator><creator>Carpenter, Linda L</creator><creator>Nyer, Maren</creator><creator>Mischoulon, David</creator><creator>Kimball, Allison</creator><creator>Deckersbach, Thilo</creator><creator>Dougherty, Darin D</creator><creator>Schoenfeld, David A</creator><creator>Fisher, Lauren</creator><creator>Cusin, Cristina</creator><creator>Dording, Christina</creator><creator>Trinh, Nhi-Ha</creator><creator>Pedrelli, Paola</creator><creator>Yeung, Albert</creator><creator>Farabaugh, Amy</creator><creator>Papakostas, George I</creator><creator>Chang, Trina</creator><creator>Shapero, Benjamin G</creator><creator>Chen, Justin</creator><creator>Cassano, Paolo</creator><creator>Hahn, Emily M</creator><creator>Rao, Elizabeth M</creator><creator>Brady, Roscoe O</creator><creator>Singh, Ravinder J</creator><creator>Tyrka, Audrey R</creator><creator>Price, Lawrence H</creator><creator>Fava, Maurizio</creator><creator>Miller, Karen K</creator><general>American Psychiatric Association</general><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>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20201001</creationdate><title>Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study</title><author>Dichtel, Laura E ; Carpenter, Linda L ; Nyer, Maren ; Mischoulon, David ; Kimball, Allison ; Deckersbach, Thilo ; Dougherty, Darin D ; Schoenfeld, David A ; Fisher, Lauren ; Cusin, Cristina ; Dording, Christina ; Trinh, Nhi-Ha ; Pedrelli, Paola ; Yeung, Albert ; Farabaugh, Amy ; Papakostas, George I ; Chang, Trina ; Shapero, Benjamin G ; Chen, Justin ; Cassano, Paolo ; Hahn, Emily M ; Rao, Elizabeth M ; Brady, Roscoe O ; Singh, Ravinder J ; Tyrka, Audrey R ; Price, Lawrence H ; Fava, Maurizio ; Miller, Karen K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a431t-61f54b57692ec36fc0058ddfe74ca6a4efee37cb4901b38e09d38964dbfd4b873</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antidepressants</topic><topic>Depressive Disorder, Major - diagnostic imaging</topic><topic>Depressive Disorder, Major - drug therapy</topic><topic>Depressive Disorder, Treatment-Resistant - diagnostic imaging</topic><topic>Depressive Disorder, Treatment-Resistant - drug therapy</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Functional Neuroimaging</topic><topic>Gyrus Cinguli - diagnostic imaging</topic><topic>Humans</topic><topic>Hydrocortisone - blood</topic><topic>Magnetic Resonance Imaging</topic><topic>Mental depression</topic><topic>Middle Aged</topic><topic>Placebo effect</topic><topic>Skin Cream</topic><topic>Testosterone</topic><topic>Testosterone - administration & dosage</topic><topic>Testosterone - blood</topic><topic>Testosterone - therapeutic use</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dichtel, Laura E</creatorcontrib><creatorcontrib>Carpenter, Linda L</creatorcontrib><creatorcontrib>Nyer, Maren</creatorcontrib><creatorcontrib>Mischoulon, David</creatorcontrib><creatorcontrib>Kimball, Allison</creatorcontrib><creatorcontrib>Deckersbach, Thilo</creatorcontrib><creatorcontrib>Dougherty, Darin D</creatorcontrib><creatorcontrib>Schoenfeld, David A</creatorcontrib><creatorcontrib>Fisher, Lauren</creatorcontrib><creatorcontrib>Cusin, Cristina</creatorcontrib><creatorcontrib>Dording, Christina</creatorcontrib><creatorcontrib>Trinh, Nhi-Ha</creatorcontrib><creatorcontrib>Pedrelli, Paola</creatorcontrib><creatorcontrib>Yeung, Albert</creatorcontrib><creatorcontrib>Farabaugh, Amy</creatorcontrib><creatorcontrib>Papakostas, George I</creatorcontrib><creatorcontrib>Chang, Trina</creatorcontrib><creatorcontrib>Shapero, Benjamin G</creatorcontrib><creatorcontrib>Chen, Justin</creatorcontrib><creatorcontrib>Cassano, Paolo</creatorcontrib><creatorcontrib>Hahn, Emily M</creatorcontrib><creatorcontrib>Rao, Elizabeth M</creatorcontrib><creatorcontrib>Brady, Roscoe O</creatorcontrib><creatorcontrib>Singh, Ravinder J</creatorcontrib><creatorcontrib>Tyrka, Audrey R</creatorcontrib><creatorcontrib>Price, Lawrence H</creatorcontrib><creatorcontrib>Fava, Maurizio</creatorcontrib><creatorcontrib>Miller, Karen K</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>The American journal of psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dichtel, Laura E</au><au>Carpenter, Linda L</au><au>Nyer, Maren</au><au>Mischoulon, David</au><au>Kimball, Allison</au><au>Deckersbach, Thilo</au><au>Dougherty, Darin D</au><au>Schoenfeld, David A</au><au>Fisher, Lauren</au><au>Cusin, Cristina</au><au>Dording, Christina</au><au>Trinh, Nhi-Ha</au><au>Pedrelli, Paola</au><au>Yeung, Albert</au><au>Farabaugh, Amy</au><au>Papakostas, George I</au><au>Chang, Trina</au><au>Shapero, Benjamin G</au><au>Chen, Justin</au><au>Cassano, Paolo</au><au>Hahn, Emily M</au><au>Rao, Elizabeth M</au><au>Brady, Roscoe O</au><au>Singh, Ravinder J</au><au>Tyrka, Audrey R</au><au>Price, Lawrence H</au><au>Fava, Maurizio</au><au>Miller, Karen K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study</atitle><jtitle>The American journal of psychiatry</jtitle><addtitle>Am J Psychiatry</addtitle><date>2020-10-01</date><risdate>2020</risdate><volume>177</volume><issue>10</issue><spage>965</spage><epage>973</epage><pages>965-973</pages><issn>0002-953X</issn><eissn>1535-7228</eissn><abstract>Objective:Low-dose testosterone has been shown to improve depression symptom severity, fatigue, and sexual function in small studies in women not formally diagnosed with major depressive disorder. The authors sought to determine whether adjunctive low-dose transdermal testosterone improves depression symptom severity, fatigue, and sexual function in women with antidepressant-resistant major depression. A functional MRI (fMRI) substudy examined effects on activity in the anterior cingulate cortex (ACC), a brain region important in mood regulation.Methods:The authors conducted an 8-week randomized double-blind placebo-controlled trial of adjunctive testosterone cream in 101 women, ages 21–70, with antidepressant-resistant major depression. The primary outcome measure was depression symptom severity as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary endpoints included fatigue, sexual function, and safety measures. The primary outcome of the fMRI substudy (N=20) was change in ACC activity.Results:The participants’ mean age was 47 years (SD=14) and their mean baseline MADRS score was 26.6 (SD=5.9). Eighty-seven (86%) participants completed 8 weeks of treatment. MADRS scores decreased in both study arms from baseline to week 8 (testosterone arm: from 26.8 [SD=6.3] to 15.3 [SD=9.6]; placebo arm: from 26.3 [SD=5.4] to 14.4 [SD=9.3]), with no significant difference between groups. Improvement in fatigue and sexual function did not differ between groups, nor did side effects. fMRI results showed a relationship between ACC activation and androgen levels before treatment but no difference in ACC activation with testosterone compared with placebo.Conclusions:Adjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction. Imaging in a subset of participants demonstrated that testosterone did not result in greater activation of the ACC.</abstract><cop>United States</cop><pub>American Psychiatric Association</pub><pmid>32660299</pmid><doi>10.1176/appi.ajp.2020.19080844</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Antidepressants Depressive Disorder, Major - diagnostic imaging Depressive Disorder, Major - drug therapy Depressive Disorder, Treatment-Resistant - diagnostic imaging Depressive Disorder, Treatment-Resistant - drug therapy Double-Blind Method Drug Therapy, Combination Female Functional Neuroimaging Gyrus Cinguli - diagnostic imaging Humans Hydrocortisone - blood Magnetic Resonance Imaging Mental depression Middle Aged Placebo effect Skin Cream Testosterone Testosterone - administration & dosage Testosterone - blood Testosterone - therapeutic use Young Adult |
| title | Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study |
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