Trial reportBMC psychiatry2016
Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials.
Trial report in BMC psychiatry, 2016. 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 5 papers.
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 Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
Who cites it
5 citing papers in PubMed.
- Home-based transcranial direct current stimulation (tDCS) for bipolar depression: effects on quality of life and functioning-an open-label study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Trial
- Lithium, the gold standard drug for bipolar disorder: analysis of current clinical studies.Naunyn-Schmiedeberg's archives of pharmacology · 2024Review
- 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
- Improving Functioning, Quality of Life, and Well-being in Patients With Bipolar Disorder.The international journal of neuropsychopharmacology · 2019Article
- Treatment of Functional Impairment in Patients with Bipolar Disorder.Current psychiatry reports · 2017Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDepressive symptoms associated with bipolar disorder negatively impact health-related quality of life (HRQoL). The efficacy of lurasidone in reducing depressive symptoms has been previously demonstrated. The objective of this study was to examine the direct and indirect effect (mediated through improvement in depression symptoms) of lurasidone in improving patient HRQoL.
methodsA secondary analysis of data was conducted of two 6-week, double-blind, placebo-controlled trials assessing the effect of lurasidone (lurasidone monotherapy [20-60 mg/day or 80-120 mg/day]; lurasidone adjunctive to lithium or valproate [20-120 mg/day]) in patients with bipolar depression. Patient HRQoL was measured using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF). Depression symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Analysis of covariance (ANCOVA) was used to estimate the effect of lurasidone on improvement in the Q-LES-Q SF percentage maximum score from baseline to 6 weeks. Path analysis was used to evaluate the total effect (β1), as well as the indirect (β2*β3) and direct (β4) effect of lurasidone on Q-LES-Q SF change through improvements in MADRS.
resultsA total of 340 and 485 patients from the monotherapy and adjunctive therapy, respectively, were included in the analysis. At 6-weeks, ANCOVA analyses demonstrated that lurasidone provided significant improvement in adjusted mean Q-LES-Q SF scores in comparison to placebo for monotherapy (22.9 and 22.7 vs. 15.2, both p < 0.01) and adjunctive therapy (23.1 vs. 17.9, p = 0.01). Path analyses indicated that lurasidone treatment predicted MADRS improvement (monotherapy: β2 = -0.44, p < 0.001; adjunctive therapy: β2 = -0.34, p = 0.003), which subsequently predicted improvement in Q-LES-Q SF (monotherapy: β3 = -0.73, p < 0.001; adjunctive therapy: β3 = -0.75, p < 0.001); however, the effect of lurasidone on improvement in Q-LES-Q SF was largely mediated by change in MADRS (monotherapy: β4 = 0.11, p = 0.13; adjunctive therapy: β4 = 0.02, p = 0.77).
conclusionsLurasidone as a monotherapy and adjunctive to lithium or valproate is an effective treatment for improving HRQoL in patients with bipolar depression. However, improvement in HRQoL was not independent of improvement in depression, indicating that the effect of lurasidone on improving patient HRQoL may act through a reduction in depressive symptoms associated with bipolar disorder.
trial registrationClinicaltrials.gov identifiers: NCT00868699 and NCT00868452 (both registered March 23, 2009).
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