Birgitte Mønster Christensen

Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus: the protocol of a randomized controlled trial

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Jocelyn Fotso Soh, Geri-PARTy Research Group, Jewish General Hospital/Lady Davis Institute, McGill University, 4333 Cote Ste-Catherine, Montreal, QC, H3T, 1E4, Montreal, Canada. jfs702@mun.ca.
  • ,
  • Susana G Torres-Platas, Geri-PARTy Research Group, Jewish General Hospital/Lady Davis Institute, McGill University, 4333 Cote Ste-Catherine, Montreal, QC, H3T, 1E4, Montreal, Canada.
  • ,
  • Serge Beaulieu, Douglas Mental Health University Institute, McGill University, Montreal, Quebec, Canada.
  • ,
  • Outi Mantere, Douglas Mental Health University Institute, McGill University, Montreal, Quebec, Canada.
  • ,
  • Robert Platt, Department of Epidemiology, Biostatistics and Occupational Health, McGill University Health Centre, Montreal, Canada.
  • ,
  • Istvan Mucsi, Division of Nephrology, University Health Network, University of Toronto (UofT), Toronto, Canada.
  • ,
  • Sybille Saury, Douglas Mental Health University Institute, McGill University, Montreal, Quebec, Canada.
  • ,
  • Suzane Renaud, Douglas Mental Health University Institute, McGill University, Montreal, Quebec, Canada.
  • ,
  • Andrea Levinson, Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, Canada.
  • ,
  • Ana C Andreazza, Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, Canada.
  • ,
  • Benoit H Mulsant, Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, Canada.
  • ,
  • Daniel Müller, Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, Canada.
  • ,
  • Ayal Schaffer, Department of Psychiatry, Sunnybrook Research Institute, University of Toronto, Toronto, Canada.
  • ,
  • Annemiek Dols, Department of Psychiatry, GGZ, Geest, Amsterdam, the Netherlands.
  • ,
  • Pablo Cervantes, Department of Psychiatry, McGill University, Montreal, QC
  • ,
  • Nancy Cp Low, Department of Psychiatry, McGill University, Montreal, QC
  • ,
  • Nathan Herrmann, Department of Psychiatry, Sunnybrook Research Institute, University of Toronto, Toronto, Canada.
  • ,
  • Birgitte M Christensen
  • Francesco Trepiccione, Division of Nephrology, University of Naples, Naples, Italy.
  • ,
  • Tarek Rajji, Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, Canada.
  • ,
  • Soham Rej, Geri-PARTy Research Group, Jewish General Hospital/Lady Davis Institute, McGill University, 4333 Cote Ste-Catherine, Montreal, QC, H3T, 1E4, Montreal, Canada., Douglas Mental Health University Institute, McGill University, Montreal, Quebec, Canada.

BACKGROUND: Lithium is the gold-standard treatment for bipolar disorder, is highly effective in treating major depressive disorder, and has anti-suicidal properties. However, clinicians are increasingly avoiding lithium largely due to fears of renal toxicity. Nephrogenic Diabetes Insipidus (NDI) occurs in 15-20% of lithium users and predicts a 2-3 times increased risk of chronic kidney disease (CKD). We recently found that use of statins is associated with lower NDI risk in a cross-sectional study. In this current paper, we describe the methodology of a randomized controlled trial (RCT) to treat lithium-induced NDI using atorvastatin.

METHODS: We will conduct a 12-week, double-blind placebo-controlled RCT of atorvastatin for lithium-induced NDI at McGill University, Montreal, Canada. We will recruit 60 current lithium users, aged 18-85, who have indicators of NDI, which we defined as urine osmolality (UOsm) < 600 mOsm/kg after 10-h fluid restriction. We will randomize patients to atorvastatin (20 mg/day) or placebo for 12 weeks. We will examine whether this improves measures of NDI: UOsm and aquaporin (AQP2) excretion at 12-week follow-up, adjusted for baseline.

RESULTS: Not applicable.

CONCLUSION: The aim of this clinical trial is to provide preliminary data about the efficacy of atorvastatin in treating NDI. If successful, lithium could theoretically be used more safely in patients with a reduced subsequent risk of CKD, hypernatremia, and acute kidney injury (AKI). If future definitive trials confirm this, this could potentially allow more patients to benefit from lithium, while minimizing renal risk.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02967653 . Registered in February 2017.

OriginalsprogEngelsk
Artikelnummer227
TidsskriftBMC Psychiatry
Vol/bind18
Nummer1
Antal sider7
ISSN1471-244X
DOI
StatusUdgivet - 16 jul. 2018

Se relationer på Aarhus Universitet Citationsformater

ID: 129947657