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Anxiety, irritability, and agitation as indicators of bipolar mania with depressive symptoms : a post hoc analysis of two clinical trials

Suppes, Trisha; Eberhard, Jonas LU ; Lemming, Ole; Young, Allan H and McIntyre, Roger S (2017) In International journal of bipolar disorders 5(1). p.36-36
Abstract

BACKGROUND: Symptoms of anxiety, irritability, and agitation (AIA) are prevalent among patients with bipolar I disorder (BD-I) mania with depressive symptoms, and could potentially be used to aid physicians in the identification of this more severe form of BD-I. Using data from two clinical trials, the aims of this post hoc analysis were to describe the phenomenology of bipolar mania in terms of AIA and depressive symptoms, and to evaluate the influence of these symptoms on the likelihood of remission during treatment.

METHODS: Patients with a BD-I manic or mixed episode (Diagnostic and Statistical Manual of Mental Disorders IV criteria) were randomised to 3 weeks of double-blind treatment with asenapine, placebo, or olanzapine... (More)

BACKGROUND: Symptoms of anxiety, irritability, and agitation (AIA) are prevalent among patients with bipolar I disorder (BD-I) mania with depressive symptoms, and could potentially be used to aid physicians in the identification of this more severe form of BD-I. Using data from two clinical trials, the aims of this post hoc analysis were to describe the phenomenology of bipolar mania in terms of AIA and depressive symptoms, and to evaluate the influence of these symptoms on the likelihood of remission during treatment.

METHODS: Patients with a BD-I manic or mixed episode (Diagnostic and Statistical Manual of Mental Disorders IV criteria) were randomised to 3 weeks of double-blind treatment with asenapine, placebo, or olanzapine (active comparator). Anxiety was defined as a score of ≥3 on the Positive and Negative Syndrome Scale 'anxiety' item, irritability as a score of ≥4 on the Young Mania Rating Scale (YMRS) 'irritability' item, and agitation as a score of ≥3 on the YMRS 'increased motor activity-energy' item. Depressive symptoms were defined as a score of ≥1 on three or more individual Montgomery-Åsberg Depression Rating Scale (MADRS) items, or a MADRS Total score of ≥20.

RESULTS: A total of 960 patients with BD-I were analysed, 665 with a manic episode and 295 with a mixed episode. At baseline, 61.4% had anxiety, 62.4% had irritability, 76.4% had agitation, and 34.0% had all three AIA symptoms ('severe AIA'); 47.3% had three or more depressive symptoms, and 13.5% had a MADRS total score of ≥20. Anxiety, irritability, and severe AIA (but not agitation) were statistically significantly more common in patients with depressive symptoms. Patients with anxiety or severe AIA at baseline were statistically significantly less likely to achieve remission (YMRS total <12). In general, remission rates were higher with asenapine and olanzapine than with placebo, irrespective of baseline AIA or depressive symptoms.

CONCLUSIONS: Assessment of AIA symptoms in bipolar mania could enable physicians to identify patients with more severe depressive symptoms, allowing for appropriate intervention. Assessment and monitoring of AIA may help physicians to predict which patients may be harder to treat and at risk for self-harm. Trial registration ClinicalTrials.gov NCT00159744, NCT00159796. Registered 8 September 2005 (retrospectively registered).

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organization
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type
Contribution to journal
publication status
published
subject
keywords
Journal Article
in
International journal of bipolar disorders
volume
5
issue
1
pages
36 - 36
publisher
Springer Open
external identifiers
  • wos:000414437500001
ISSN
2194-7511
DOI
10.1186/s40345-017-0103-7
language
English
LU publication?
yes
id
61590a7e-1cf0-4155-9a81-92dc74686e8d
date added to LUP
2017-11-26 23:36:53
date last changed
2018-01-16 13:26:31
@article{61590a7e-1cf0-4155-9a81-92dc74686e8d,
  abstract     = {<p>BACKGROUND: Symptoms of anxiety, irritability, and agitation (AIA) are prevalent among patients with bipolar I disorder (BD-I) mania with depressive symptoms, and could potentially be used to aid physicians in the identification of this more severe form of BD-I. Using data from two clinical trials, the aims of this post hoc analysis were to describe the phenomenology of bipolar mania in terms of AIA and depressive symptoms, and to evaluate the influence of these symptoms on the likelihood of remission during treatment.</p><p>METHODS: Patients with a BD-I manic or mixed episode (Diagnostic and Statistical Manual of Mental Disorders IV criteria) were randomised to 3 weeks of double-blind treatment with asenapine, placebo, or olanzapine (active comparator). Anxiety was defined as a score of ≥3 on the Positive and Negative Syndrome Scale 'anxiety' item, irritability as a score of ≥4 on the Young Mania Rating Scale (YMRS) 'irritability' item, and agitation as a score of ≥3 on the YMRS 'increased motor activity-energy' item. Depressive symptoms were defined as a score of ≥1 on three or more individual Montgomery-Åsberg Depression Rating Scale (MADRS) items, or a MADRS Total score of ≥20.</p><p>RESULTS: A total of 960 patients with BD-I were analysed, 665 with a manic episode and 295 with a mixed episode. At baseline, 61.4% had anxiety, 62.4% had irritability, 76.4% had agitation, and 34.0% had all three AIA symptoms ('severe AIA'); 47.3% had three or more depressive symptoms, and 13.5% had a MADRS total score of ≥20. Anxiety, irritability, and severe AIA (but not agitation) were statistically significantly more common in patients with depressive symptoms. Patients with anxiety or severe AIA at baseline were statistically significantly less likely to achieve remission (YMRS total &lt;12). In general, remission rates were higher with asenapine and olanzapine than with placebo, irrespective of baseline AIA or depressive symptoms.</p><p>CONCLUSIONS: Assessment of AIA symptoms in bipolar mania could enable physicians to identify patients with more severe depressive symptoms, allowing for appropriate intervention. Assessment and monitoring of AIA may help physicians to predict which patients may be harder to treat and at risk for self-harm. Trial registration ClinicalTrials.gov NCT00159744, NCT00159796. Registered 8 September 2005 (retrospectively registered).</p>},
  author       = {Suppes, Trisha and Eberhard, Jonas and Lemming, Ole and Young, Allan H and McIntyre, Roger S},
  issn         = {2194-7511},
  keyword      = {Journal Article},
  language     = {eng},
  month        = {11},
  number       = {1},
  pages        = {36--36},
  publisher    = {Springer Open},
  series       = {International journal of bipolar disorders},
  title        = {Anxiety, irritability, and agitation as indicators of bipolar mania with depressive symptoms : a post hoc analysis of two clinical trials},
  url          = {http://dx.doi.org/10.1186/s40345-017-0103-7},
  volume       = {5},
  year         = {2017},
}