A randomized, double-blind, placebo-controlled proof-of-concept study of ondansetron for bipolar and related disorders and alcohol use disorder

Brown, E. Sherwood; McArdle, Meagan; Palka, Jayme M.; Bice, Collette; Ivleva, Elena I.; Nakamura, Alyson; McNutt, Markey C.; Patel, Zena; Holmes, Traci; Tipton, Shane

doi:10.1016/j.euroneuro.2020.12.006

Cited by 8 publications

(3 citation statements)

References 49 publications

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“…Conversely, Quetiapine has been tested in three randomized-controlled trials but proved useless for alcohol-related outcomes [ 128 ], though being effective on depressive symptoms in a sample of outpatients with AUD-BD [ 131 ]. A similar finding was recently reported for Ondansetron in a sample of adults with bipolar spectrum disorders and comorbid early-onset AUD [ 132 ]. Aripiprazole, instead, showed some superiority against placebo on secondary outcomes, including marginal effects on the number of drinks per drinking day and a time-limited decrease in percent carbohydrate-deficient transferrin, possibly suggesting that low doses may be preferred [ 133 ].…”

Section: Substance Use Disorderssupporting

confidence: 89%

Comorbidities in Youth with Bipolar Disorder: Clinical Features and Pharmacological Management

Sesso

Brancati

Masi

2023

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Background: Bipolar Disorder (BD) is a highly comorbid condition, and rates of co-occurring disorders are even higher in youth. Comorbid disorders strongly affect clinical presentation, natural course, prognosis, and treatment. Method: This review focuses on the clinical and treatment implications of the comorbidity between BD and Attention-Deficit/Hyperactivity Disorder (ADHD), disruptive behavior disorders (Oppositional Defiant Disorder and/or Conduct Disorder), alcohol and substance use disorders, Autism Spectrum Disorder, anxiety disorders, Obsessive-Compulsive Disorder, and eating disorders. Results: These associations define specific conditions which are not simply a sum of different clinical pictures, but occur as distinct and complex combinations with specific developmental pathways over time and selective therapeutic requirements. Pharmacological treatments can improve these clinical pictures by addressing the comorbid conditions, though the same treatments may also worsen BD by inducing manic or depressive switches. Conclusion: The timely identification of BD comorbidities may have relevant clinical implications in terms of symptomatology, course, treatment and outcome. Specific studies addressing the pharmacological management of BD and comorbidities are still scarce, and information is particularly lacking in children and adolescents; for this reason, the present review also included studies conducted on adult samples. Developmentally-sensitive controlled clinical trials are thus warranted to improve the prognosis of these highly complex patients, requiring timely and finely personalized therapies.

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Section: Substance Use Disorderssupporting

confidence: 89%

Comorbidities in Youth with Bipolar Disorder: Clinical Features and Pharmacological Management

Sesso

Brancati

Masi

2023

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“…However, improvement of mood was not confirmed in a double-blind study with naltrexone add-on to cognitive behavioral therapy, and there was only a trend toward less alcohol consumption (121). Similar disappointing results have been reported from a controlled study with acamprosate in BD + AUD (122).…”

Section: Pharmacological Optionsmentioning

confidence: 69%

Comorbid Bipolar and Alcohol Use Disorder—A Therapeutic Challenge

et al. 2021

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Comorbidity rates in Bipolar disorder rank highest among major mental disorders, especially comorbid substance use. Besides cannabis, alcohol is the most frequent substance of abuse as it is societally accepted and can be purchased and consumed legally. Estimates for lifetime comorbidity of bipolar disorder and alcohol use disorder are substantial and in the range of 40–70%, both for Bipolar I and II disorder, and with male preponderance. Alcohol use disorder and bipolarity significantly influence each other's severity and prognosis with a more complicated course of both disorders. Modern treatment concepts acknowledge the interplay between these disorders using an integrated therapy approach where both disorders are tackled in the same setting by a multi-professional team. Motivational interviewing, cognitive behavioral and socio- therapies incorporating the family and social environment are cornerstones in psychotherapy whereas the accompanying pharmacological treatment aims to reduce craving and to optimize mood stability. Adding valproate to lithium may reduce alcohol consumption whereas studies with antipsychotics or naltrexone and acamprosate did not affect mood fluctuations or drinking patterns. In summary, there is a continuous need for more research in order to develop evidence-based approaches for integrated treatment of this frequent comorbidity.

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“…This review contains six newly added studies conducted with patients on baclofen, five with patients on varenicline, four with patients on topiramate and zonisamide, three with patients on naltrexone, two with patients on gabapentin and XR-NTX and one study each in patients on carbamazepine, levetiracetam, nalmefene, pregabalin or valproate. Studies of ondansetron and oxcarbazepine were excluded because they did not fit into our PICO strategy [78][79][80][81][82][83]. Thirty-six studies (65%) were performed in North America, 14 (25%) in Europe, three (6%) in Australia and two (4%) in Asia.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Efficacy and safety of alcohol reduction pharmacotherapy according to treatment duration in patients with alcohol dependence or alcohol use disorder: A systematic review and network meta‐analysis

Kotake,

Hosokawa,

Tanaka

et al. 2024

Addiction

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Background and AimsRelapse is common in alcohol dependence (AD) and alcohol use disorder (AUD), so alcohol reduction therapy should be measured over as long a period as possible; however, existing reviews do not consider the duration of treatment and therefore alcohol reduction therapy may not have been appropriately evaluated. This review evaluated the efficacy and safety of alcohol reduction pharmacotherapy in patients with AD or AUD according to the duration of treatment.MethodsWe conducted a systematic review and network meta‐analysis of randomized controlled trials (RCTs) that assessed 15 pharmacological agents. MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Trials, the ClinicalTrials.gov and the International Clinical Trials Registry Platform were searched for eligible trials through to May 2021. Outcomes were heavy drinking days (HDD), total alcohol consumption (TAC), any adverse event and days without drinking.ResultsFifty‐five RCTs (n = 8891) were included. Nalmefene was superior to placebo for reducing HDD (standard mean difference [SMD] −0.28, 95% confidence interval [CI] −0.37, −0.18) and TAC (SMD −0.25, 95% CI −0.35, −0.16) in the long‐term, but not in the short‐term. Topiramate was superior to placebo for reducing HDD (SMD −0.35, 95% CI −0.59, −0.12) and days without drinking (SMD 0.46, 95% CI 0.11, 0.82), and baclofen was superior for reducing TAC (SMD −0.70, 95% CI −1.29, −0.11), in the short‐term. The frequency of adverse events was higher with nalmefene and topiramate than with placebo.ConclusionNalmefene, topiramate and baclofen may be effective as alcohol reduction pharmacotherapy; however, only nalmefene has demonstrated long‐term efficacy, and nalmefene and topiramate have a significantly higher frequency of adverse events compared with placebo.

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A randomized, double-blind, placebo-controlled proof-of-concept study of ondansetron for bipolar and related disorders and alcohol use disorder

Cited by 8 publications

References 49 publications

Comorbidities in Youth with Bipolar Disorder: Clinical Features and Pharmacological Management

Comorbidities in Youth with Bipolar Disorder: Clinical Features and Pharmacological Management

Comorbid Bipolar and Alcohol Use Disorder—A Therapeutic Challenge

Efficacy and safety of alcohol reduction pharmacotherapy according to treatment duration in patients with alcohol dependence or alcohol use disorder: A systematic review and network meta‐analysis

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