Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety. Protocol for a systematic review

<p>Introduction. Gabapentin has been extensively prescribed off-label for psychiatric indications, with little established evidence of efficacy. Both gabapentin and pregabalin, a very similar drug with the same mechanism of action, bind to a subunit of voltage dependent calcium channels, which...

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Main Authors: Houghton, K, Forrest, A, Awad, A, Cipriani, A, Atkinson, L, Stockton, S, Harrison, P, Geddes, J
Format: Journal article
Published: BMJ Publishing Group 2017
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author Houghton, K
Forrest, A
Awad, A
Cipriani, A
Atkinson, L
Stockton, S
Harrison, P
Geddes, J
author_facet Houghton, K
Forrest, A
Awad, A
Cipriani, A
Atkinson, L
Stockton, S
Harrison, P
Geddes, J
author_sort Houghton, K
collection OXFORD
description <p>Introduction. Gabapentin has been extensively prescribed off-label for psychiatric indications, with little established evidence of efficacy. Both gabapentin and pregabalin, a very similar drug with the same mechanism of action, bind to a subunit of voltage dependent calcium channels, which are implicated in the aetiopathogenesis of bipolar disorder, anxiety and insomnia. This systematic review and meta-analysis aims to collect and critically appraise all the available evidence about efficacy and tolerability of gabapentin and pregabalin in the treatment of bipolar disorder, insomnia and anxiety. </p> <p>Methods and analysis. We will include all randomized controlled trials reported as double-blind and comparing gabapentin or pregabalin with placebo or any other active pharmacological treatment (any preparation, dose, frequency, route of delivery or setting) in patients with bipolar disorder, anxiety or insomnia. For consideration of adverse effects (tolerability), single blind or open label RCTs and non-randomised evidence will also be summarised. The main outcomes will be efficacy (measured both as dichotomous and continuous outcome) and acceptability (proportion of patients who dropped out of the allocated treatment). Published and unpublished studies will be sought through relevant database searches, trial registries and websites; all reference selection and data extraction will be conducted by at least two independent reviewers. We will conduct a random-effects meta-analysis to synthesize all evidence for each outcome. Heterogeneity between studies will be investigated by the I2 statistic. Data from included studies will be entered into a funnel plot for investigation of small-study effects. No subgroup analysis will be undertaken, but we will carry out sensitivity analyses about combination treatment, psychiatric comorbidity, use of rescue medications and fixed versus random-effects model. </p>
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spelling oxford-uuid:cbadb7f0-29be-45fa-b615-4d2128fd80e22022-03-27T07:16:30ZBiological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety. Protocol for a systematic reviewJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:cbadb7f0-29be-45fa-b615-4d2128fd80e2Symplectic Elements at OxfordBMJ Publishing Group2017Houghton, KForrest, AAwad, ACipriani, AAtkinson, LStockton, SHarrison, PGeddes, J<p>Introduction. Gabapentin has been extensively prescribed off-label for psychiatric indications, with little established evidence of efficacy. Both gabapentin and pregabalin, a very similar drug with the same mechanism of action, bind to a subunit of voltage dependent calcium channels, which are implicated in the aetiopathogenesis of bipolar disorder, anxiety and insomnia. This systematic review and meta-analysis aims to collect and critically appraise all the available evidence about efficacy and tolerability of gabapentin and pregabalin in the treatment of bipolar disorder, insomnia and anxiety. </p> <p>Methods and analysis. We will include all randomized controlled trials reported as double-blind and comparing gabapentin or pregabalin with placebo or any other active pharmacological treatment (any preparation, dose, frequency, route of delivery or setting) in patients with bipolar disorder, anxiety or insomnia. For consideration of adverse effects (tolerability), single blind or open label RCTs and non-randomised evidence will also be summarised. The main outcomes will be efficacy (measured both as dichotomous and continuous outcome) and acceptability (proportion of patients who dropped out of the allocated treatment). Published and unpublished studies will be sought through relevant database searches, trial registries and websites; all reference selection and data extraction will be conducted by at least two independent reviewers. We will conduct a random-effects meta-analysis to synthesize all evidence for each outcome. Heterogeneity between studies will be investigated by the I2 statistic. Data from included studies will be entered into a funnel plot for investigation of small-study effects. No subgroup analysis will be undertaken, but we will carry out sensitivity analyses about combination treatment, psychiatric comorbidity, use of rescue medications and fixed versus random-effects model. </p>
spellingShingle Houghton, K
Forrest, A
Awad, A
Cipriani, A
Atkinson, L
Stockton, S
Harrison, P
Geddes, J
Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety. Protocol for a systematic review
title Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety. Protocol for a systematic review
title_full Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety. Protocol for a systematic review
title_fullStr Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety. Protocol for a systematic review
title_full_unstemmed Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety. Protocol for a systematic review
title_short Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety. Protocol for a systematic review
title_sort biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder insomnia and anxiety protocol for a systematic review
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