Influence of adjuvant clonidine on mania, sleep disturbances and cognitive performance – Results from a double-blind and placebo-controlled randomized study in individuals with bipolar I disorder during their manic phase

Ahmadpanah, Mohammad; Pezeshki, Rana; Soltanian, Ali Reza; Jahangard, Leila; Dürsteler, Kenneth M.; Rafieemehr, Hassan; Brand, Serge

doi:10.1016/j.jpsychires.2021.12.035

Cited by 12 publications

(24 citation statements)

References 49 publications

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“…Nine studies reporting change in manic symptom severity post-clonidine met the inclusion criteria for the systematic review. Five RCTs comparing clonidine to placebo/control (lithium or verapamil) [ 22 , 28 , 29 , 30 , 31 ], and four non-randomized studies—three open-label studies [ 14 , 15 , 32 ] and one double blind study [ 33 ]—were included ( Figure 1 ).…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Nine studies [ 14 , 15 , 22 , 28 , 29 , 30 , 31 , 32 , 33 ] enrolled 222 patients with acute mania/hypomania/mixed symptoms (mean age 37.2 ± 13.0 years, females = 33.7%). Only one [ 22 ] of the five RCTs used adjunctive clonidine to lithium treatment while the remaining four studies explored the efficacy of monotherapy with clonidine for mania. Among the non-randomized studies, only one study examined the role of clonidine as monotherapy [ 33 ], while the other three studies enrolled participants who received either monotherapy or adjunctive clonidine.…”

Section: Resultsmentioning

confidence: 99%

“…With the advancement in the understanding of neurobiology of psychiatric disorders, there is an interest in the field to repurpose older drugs that are safe and have good tolerability [ 21 ]. A recent randomized controlled trial (RCT) showed promising results with adjuvant clonidine use for mania among inpatients with BD [ 22 ], thus, reinvigorating interest in clonidine’s use as a treatment option for acute mania.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Clonidine in the Treatment of Acute Mania in Bipolar Disorder: A Systematic Review

et al. 2023

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Clonidine, an alpha-2 adrenergic agonist, has been proposed as an antimanic agent that acts by reducing noradrenergic transmission. We conducted a systematic review to examine the efficacy and safety of clonidine for acute mania/hypomania. A comprehensive literature search was performed to identify randomized controlled trials (RCT) and non-randomized studies investigating the efficacy and safety of monotherapy/adjuvant treatment with clonidine for acute mania/hypomania in patients with bipolar disorder (BD). Nine studies (n = 222) met our inclusion criteria, including five RCTs (n = 159) and four non-randomized studies (n = 63). Non-randomized studies showed clonidine to help reduce symptoms of mania. However, data from placebo controlled RCTs were inconsistent. One RCT showed adjuvant clonidine as superior to placebo, whereas another RCT reported that clonidine was not better than placebo. In individual RCTs, lithium and valproate offered better antimanic effects compared to clonidine. Studies reported hypotension, depression, and somnolence as common adverse effects. Significant differences in study design and sample size contributed to high heterogeneity. This systematic review suggests low-grade evidence for clonidine as an adjuvant treatment for acute mania with mood stabilizers and inconclusive efficacy as monotherapy, warranting further well-designed RCTs.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Clonidine in the Treatment of Acute Mania in Bipolar Disorder: A Systematic Review

et al. 2023

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“…Excitement abounds with any addition to the psychiatric armamentarium, but until a tolerable hemodynamic profile can be established, perhaps we should look to the more familiar clonidine for agitation management. While not without hemodynamic risks, clonidine has been studied for decades as adjuvant treatment for mania and can attenuate agitation related to dexmedetomidine discontinuation in the pediatric intensive care unit . Clonidine already exists in oral tablet, oral liquid, transdermal patch, and intravenous formulations, allowing for use in many settings.…”

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confidence: 99%

Sublingual Dexmedetomidine vs Placebo and Acute Agitation Associated With Bipolar Disorder

Henry

Dantz

2022

JAMA

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Lithium, the gold standard drug for bipolar disorder: analysis of current clinical studies

Airainer,

Seifert

2024

Naunyn-Schmiedeberg's Arch Pharmacol

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Lithium is the gold standard drug in the treatment of bipolar disorder. Despite increasing scientific interest, relatively few patients with bipolar disorder receive lithium therapy. Lithium is the only drug that is effective in the prophylaxis of manic, depressive, and suicidal symptoms. Lithium therapy is also associated with a variety of adverse drug reactions and the need for therapeutic drug monitoring. Numerous studies have focussed on the efficacy and safety of both lithium-monotherapy and lithium-add-on therapy. The aim of this study is to provide a systematic overview of clinical studies on lithium therapy for bipolar disorder from the last 7 years and to present a critical analysis of these studies. The results provide an up-to-date overview of the efficacy, tolerability, and safety of lithium therapy for bipolar disorder and thus improve the pharmacotherapy of bipolar disorder. A total of 59 studies were analysed using various analysis parameters. The studies were also categorised into different subgroups. These are lithium-monotherapy, lithium vs. placebo/drug, and lithium + adjunctive therapy. The majority of the studies (N = 20) had a duration of only 3–8 weeks. Only 13 studies lasted for > 40 weeks. Lithium was superior to aripiprazole, valproic acid, and quetiapine in terms of improving manic symptoms. Lithium therapy resulted in a lower relapse rate compared to valproic acid therapy. Lithium was more neuroprotectively effective than quetiapine. Fourteen of the 22 add-on therapies to lithium showed a predominantly positive effect on the treatment outcome compared to lithium-monotherapy. Only the add-on therapy with sertraline led to a higher rate of study discontinuations than lithium-monotherapy. Lithium is a safe and effective treatment option for children. However, risperidone and quetiapine were superior to lithium in some aspects, which is why these drugs should be considered as an alternative treatment option for children. Collectively, current clinical studies highlight the relevance of lithium in the treatment of bipolar disorder.

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Influence of adjuvant clonidine on mania, sleep disturbances and cognitive performance – Results from a double-blind and placebo-controlled randomized study in individuals with bipolar I disorder during their manic phase

Cited by 12 publications

References 49 publications

Efficacy and Safety of Clonidine in the Treatment of Acute Mania in Bipolar Disorder: A Systematic Review

Efficacy and Safety of Clonidine in the Treatment of Acute Mania in Bipolar Disorder: A Systematic Review

Sublingual Dexmedetomidine vs Placebo and Acute Agitation Associated With Bipolar Disorder

Lithium, the gold standard drug for bipolar disorder: analysis of current clinical studies

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