ArticleDepression and anxiety2016
LURASIDONE IN THE LONG-TERM TREATMENT OF PATIENTS WITH BIPOLAR DISORDER: A 24-WEEK OPEN-LABEL EXTENSION STUDY.
Article in Depression and anxiety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 69 citations in OpenAlex.
- Second Generation Antipsychotics Monotherapy as Maintenance Treatment for Bipolar Disorder: a Systematic Review of Long-Term Studies.The Psychiatric quarterly · 2020Pooled it
- Lurasidone in the Treatment of Bipolar Depression: Systematic Review of Systematic Reviews.BioMed research international · 2017Pooled it
- Long-term safety and tolerability of lumateperone 42 mg in patients with bipolar disorder: results from a 6-month open-label extension study.International clinical psychopharmacology · 2026Trial
- Pramipexole in addition to mood stabilisers for treatment-resistant bipolar depression: the PAX-BD randomised double-blind placebo-controlled trial.Health technology assessment (Winchester, England) · 2025Trial
- Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression.Journal of Zhejiang University. Science. B · 2025Trial
- Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression.Psychiatry and clinical neurosciences · 2020Trial
- Article
- Advances in Mood Disorder Pharmacotherapy: Evaluating New Antipsychotics and Mood Stabilizers for Bipolar Disorder and Schizophrenia.Medical science monitor : international medical journal of experimental and clinical research · 2024Review
- Pharmacological Treatment of Bipolar Depression: A Review of Observational Studies.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Efficacy and safety of adjunctive therapy to lamotrigine, lithium, or valproate monotherapy in bipolar depression: a systematic review and meta-analysis of randomized controlled trials.International journal of bipolar disorders · 2022Review
- Risk of Drug-induced Movement Disorders with Newer Antipsychotic Agents.Tremor and other hyperkinetic movements (New York, N.Y.) · 2022Review
- Lurasidone in Therapy of Treatment-resistant Ultra-rapid Cycling Bipolar Disorder: Case Report.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2021Article
- Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study.International journal of bipolar disorders · 2021Article
- Controversies in bipolar disorder; role of second-generation antipsychotic for maintenance therapy.International journal of bipolar disorders · 2019Review
- Long-term use of lurasidone in patients with bipolar disorder: safety and effectiveness over 2 years of treatment.International journal of bipolar disorders · 2017Article
- The metabolic side effects of 12 antipsychotic drugs used for the treatment of schizophrenia on glucose: a network meta-analysis.BMC psychiatry · 2017Article
- Schizophrenia relapse, patient considerations, and potential role of lurasidone.Patient preference and adherence · 2016Review
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of this study was to evaluate the safety and tolerability of 6 months of open-label, uncontrolled extension treatment with lurasidone in patients with a diagnosis of bipolar depression who completed 6 weeks of acute treatment.
methodsPatients completing 6 weeks of double-blind placebo-controlled treatment with either lurasidone monotherapy (one study) or adjunctive therapy with lithium or valproate (two studies), were treated for 6 months with flexible doses of lurasidone, 20-120 mg/day, in an open-label, uncontrolled extension study (N = 813; monotherapy, 38.9%; adjunctive therapy, 61.1%). Changes in safety parameters were calculated from double-blind, acute-phase baseline to month 6 of the extension phase, using a last observation carried forward (LOCF endpoint) analysis.
resultsFive hundred fifty-nine of 817 (68.4%) patients completed the extension study. In the monotherapy and adjunctive therapy groups, 6.9 and 9.0%, respectively, discontinued due to an adverse event. For the monotherapy and adjunctive therapy groups, respectively, changes from double-blind baseline to month 6 were +0.8 and +0.9 kg for weight (mean), 0.0 and +2.0 mg/dL for total cholesterol (median), +5.0 and +5.0 mg/dL for triglycerides (median), -1.0 and 0.0 mg/dL for glucose (median); -22.6 and -21.7 for Montgomery-Asberg Depression Rating Scale (MADRS; mean); whereas change from open-label baseline to month 6 were +0.85 and +0.88 kg for weight (mean), and -6.9 and -6.5 for MADRS (mean).
conclusionsSix months of treatment with open-label lurasidone was safe and well tolerated with minimal effect on weight and metabolic parameters; continued improvement in depressive symptoms was observed.
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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.