Trial reportBMC psychiatry2011
Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes: a post hoc analysis of two 3-week clinical trials.
Trial report in BMC psychiatry, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs. Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501004 (Secondary Title: ARES)
A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs. Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501005 (Secondary Title: ARES)
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.
- Efficacy of pharmacotherapy in bipolar disorder: a report by the WPA section on pharmacopsychiatry.European archives of psychiatry and clinical neuroscience · 2012Pooled it
- Asenapine pharmacokinetics and tolerability in a pediatric population.Drug design, development and therapy · 2018Trial
- Efficacy and Tolerability of Asenapine Compared with Olanzapine in Borderline Personality Disorder: An Open-Label Randomized Controlled Trial.CNS drugs · 2017Trial
- Mood Stabilizers of First and Second Generation.Brain sciences · 2023Review
- Application of Antipsychotic Drugs in Mood Disorders.Brain sciences · 2023Review
- New Atypical Antipsychotics in the Treatment of Schizophrenia and Depression.International journal of molecular sciences · 2022Review
- Review
- A Review of Asenapine in the Treatment of Bipolar Disorder.Clinical drug investigation · 2018Review
- Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight.Neuropsychiatric disease and treatment · 2018Article
- Does the efficacy of asenapine in bipolar disorder increase in the presence of comorbidity with a substance use disorder? A naturalistic study.Therapeutic advances in psychopharmacology · 2017Article
- The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 2: Review, Grading of the Evidence, and a Precise Algorithm.The international journal of neuropsychopharmacology · 2017Review
- Reversal of olanzapine-induced weight gain in a patient with schizophrenia by switching to asenapine: a case report.Neuropsychiatric disease and treatment · 2017Article
- Asenapine augmentation in bipolar disorders: a case series.Clinical case reports · 2016Article
- Review
- Asenapine for bipolar disorder.Neuropsychiatric disease and treatment · 2015Review
- Challenging Treatment-Resistant Major Depressive Disorder: A Roadmap for Improved Therapeutics.Current neuropharmacology · 2015Review
- Adjunctive treatment with asenapine augments the escitalopram-induced effects on monoaminergic outflow and glutamatergic neurotransmission in the medial prefrontal cortex of the rat.The international journal of neuropsychopharmacology · 2014Article
- The effects of novel and newly approved antipsychotics on serum prolactin levels: a comprehensive review.CNS drugs · 2014Review
- Asenapine in bipolar I disorder: evidence and place in patient management.Therapeutic advances in chronic disease · 2013Article
- Receptor mechanisms of antipsychotic drug action in bipolar disorder - focus on asenapine.Therapeutic advances in psychopharmacology · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAsenapine demonstrated superiority over placebo for mania in bipolar I disorder patients experiencing acute current manic or mixed episodes in 2 randomized, placebo-and olanzapine-controlled trials. We report the results of exploratory pooled post hoc analyses from these trials evaluating asenapine's effects on depressive symptoms in patients from these trials with significant baseline depressive symptoms.
methodsIn the original trials (A7501004 [NCT00159744], A7501005 [NCT00159796]), 977 patients were randomized to flexible-dose sublingual asenapine (10 mg twice daily on day 1; 5 or 10 mg twice daily thereafter), placebo, or oral olanzapine 5-20 mg once daily for 3 weeks. Three populations were defined using baseline depressive symptoms: (1) Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥20 (n = 132); (2) Clinical Global Impression for Bipolar Disorder-Depression (CGI-BP-D) scale severity score ≥4 (n = 170); (3) diagnosis of mixed episodes (n = 302) by investigative site screening. For each population, asenapine and olanzapine were independently compared with placebo using least squares mean change from baseline on depressive symptom measures.
resultsDecreases in MADRS total score were statistically greater with asenapine versus placebo at days 7 and 21 in all populations; differences between olanzapine and placebo were not significant. Decreases in CGI-BP-D score were significantly greater with asenapine versus placebo at day 7 in all categories and day 21 in population 1; CGI-BP-D score reductions were significantly greater with olanzapine versus placebo at day 21 in population 1 and day 7 in populations 2 and 3.
conclusionsThese post hoc analyses show that asenapine reduced depressive symptoms in bipolar I disorder patients experiencing acute manic or mixed episodes with clinically relevant depressive symptoms at baseline; olanzapine results appeared to be less consistent. Controlled studies of asenapine in patients with acute bipolar depression are necessary to confirm the generalizability of these findings.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.