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A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.

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Title: A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.
Authors: Towbin, Kenneth1 (AUTHOR), Vidal-Ribas, Pablo1,2 (AUTHOR), Brotman, Melissa A.3 (AUTHOR), Pickles, Andrew2 (AUTHOR), Miller, Katherine V.1 (AUTHOR), Kaiser, Ariela1 (AUTHOR), Vitale, Aria D.1 (AUTHOR), Engel, Chana1 (AUTHOR), Overman, Gerald P.4 (AUTHOR), Davis, Mollie5 (AUTHOR), Lee, Beth6 (AUTHOR), McNeil, Cheri5 (AUTHOR), Wheeler, Wanda5 (AUTHOR), Yokum, Catherine H.5 (AUTHOR), Haring, Catherine T.7 (AUTHOR), Roule, Alexandra8 (AUTHOR), Wambach, Caroline G.9 (AUTHOR), Sharif-Askary, Banafsheh10 (AUTHOR), Pine, Daniel S.11 (AUTHOR), Leibenluft, Ellen5 (AUTHOR)
Source: Journal of the American Academy of Child & Adolescent Psychiatry. Mar2020, Vol. 59 Issue 3, p350-361. 12p.
Subject Terms: Citalopram, Serotonin uptake inhibitors, Treatment effectiveness, Drugs
Abstract: Objective: Despite the clinical importance of chronic and severe irritability, there is a paucity of controlled trials for its pharmacological treatment. Here, we examine the effects of adding citalopram (CTP) to methylphenidate (MPH) in the treatment of chronic severe irritability in youth using a double-blind randomized placebo-controlled design.Method: After a lead-in phase of open treatment with stimulant, 53 youth meeting criteria for severe mood dysregulation (SMD) were randomly assigned to receive CTP or placebo (PBO) for 8 weeks. A total of 49 participants, 48 of them (98%) meeting disruptive mood dysregulation disorder (DMDD) criteria, were included in the intent-to-treat analysis. The primary outcome measure was the proportion of response based on improvements of irritability at the week 8 of the trial.Results: At the end of the trial, a significantly higher proportion of response was seen in those participants randomly assigned to CTP+MPH compared to PBO+MPH (35% CTP+MPH versus 6% PBO+MPH; odds ratio = 11.70, 95% CI = 2.00-68.16, p = 0.006). However, there were no differences in functional impairment between groups at the end of the trial. No differences were found in any adverse effect between treatment groups, and no trial participant exhibited hypomanic or manic symptoms.Conclusion: Adjunctive CTP might be efficacious in the treatment of chronic severe irritability in youth resistant to stimulant treatment alone.Clinical Trial Registration Information: A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation; https://clinicaltrials.gov; NCT00794040. [ABSTRACT FROM AUTHOR]
Copyright of Journal of the American Academy of Child & Adolescent Psychiatry is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Education Research Complete
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DbLabel: Education Research Complete
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PubType: Academic Journal
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  Data: A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.
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  Data: <searchLink fieldCode="AR" term="%22Towbin%2C+Kenneth%22">Towbin, Kenneth</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Vidal-Ribas%2C+Pablo%22">Vidal-Ribas, Pablo</searchLink><relatesTo>1,2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brotman%2C+Melissa+A%2E%22">Brotman, Melissa A.</searchLink><relatesTo>3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pickles%2C+Andrew%22">Pickles, Andrew</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Miller%2C+Katherine+V%2E%22">Miller, Katherine V.</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kaiser%2C+Ariela%22">Kaiser, Ariela</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Vitale%2C+Aria+D%2E%22">Vitale, Aria D.</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Engel%2C+Chana%22">Engel, Chana</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Overman%2C+Gerald+P%2E%22">Overman, Gerald P.</searchLink><relatesTo>4</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Davis%2C+Mollie%22">Davis, Mollie</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lee%2C+Beth%22">Lee, Beth</searchLink><relatesTo>6</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22McNeil%2C+Cheri%22">McNeil, Cheri</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wheeler%2C+Wanda%22">Wheeler, Wanda</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yokum%2C+Catherine+H%2E%22">Yokum, Catherine H.</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Haring%2C+Catherine+T%2E%22">Haring, Catherine T.</searchLink><relatesTo>7</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Roule%2C+Alexandra%22">Roule, Alexandra</searchLink><relatesTo>8</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wambach%2C+Caroline+G%2E%22">Wambach, Caroline G.</searchLink><relatesTo>9</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sharif-Askary%2C+Banafsheh%22">Sharif-Askary, Banafsheh</searchLink><relatesTo>10</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pine%2C+Daniel+S%2E%22">Pine, Daniel S.</searchLink><relatesTo>11</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Leibenluft%2C+Ellen%22">Leibenluft, Ellen</searchLink><relatesTo>5</relatesTo> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Journal+of+the+American+Academy+of+Child+%26+Adolescent+Psychiatry%22">Journal of the American Academy of Child & Adolescent Psychiatry</searchLink>. Mar2020, Vol. 59 Issue 3, p350-361. 12p.
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  Data: <searchLink fieldCode="DE" term="%22Citalopram%22">Citalopram</searchLink><br /><searchLink fieldCode="DE" term="%22Serotonin+uptake+inhibitors%22">Serotonin uptake inhibitors</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+effectiveness%22">Treatment effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Drugs%22">Drugs</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: <bold>Objective: </bold>Despite the clinical importance of chronic and severe irritability, there is a paucity of controlled trials for its pharmacological treatment. Here, we examine the effects of adding citalopram (CTP) to methylphenidate (MPH) in the treatment of chronic severe irritability in youth using a double-blind randomized placebo-controlled design.<bold>Method: </bold>After a lead-in phase of open treatment with stimulant, 53 youth meeting criteria for severe mood dysregulation (SMD) were randomly assigned to receive CTP or placebo (PBO) for 8 weeks. A total of 49 participants, 48 of them (98%) meeting disruptive mood dysregulation disorder (DMDD) criteria, were included in the intent-to-treat analysis. The primary outcome measure was the proportion of response based on improvements of irritability at the week 8 of the trial.<bold>Results: </bold>At the end of the trial, a significantly higher proportion of response was seen in those participants randomly assigned to CTP+MPH compared to PBO+MPH (35% CTP+MPH versus 6% PBO+MPH; odds ratio = 11.70, 95% CI = 2.00-68.16, p = 0.006). However, there were no differences in functional impairment between groups at the end of the trial. No differences were found in any adverse effect between treatment groups, and no trial participant exhibited hypomanic or manic symptoms.<bold>Conclusion: </bold>Adjunctive CTP might be efficacious in the treatment of chronic severe irritability in youth resistant to stimulant treatment alone.<bold>Clinical Trial Registration Information: </bold>A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation; https://clinicaltrials.gov; NCT00794040. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Journal of the American Academy of Child & Adolescent Psychiatry is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=ehh&AN=141829443
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        Value: 10.1016/j.jaac.2019.05.015
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        Text: English
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      – TitleFull: A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.
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