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Cohort Study
Adverse events associated with mood stabiliser treatment should be continuously monitored in patients diagnosed with bipolar affective disorder
  1. R E Nielsen1,2,
  2. R W Licht3
  1. 1Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
  2. 2Department of Psychiatry, Unit for Psychiatric Research, Aalborg University Hospital, Aalborg, Denmark
  3. 3Unit for Psychiatric Research, Aalborg University Hospital, Psychiatry, Aalborg, Denmark
  1. Correspondence to: Associate Professor René Ernst Nielsen, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark, & Aalborg University Hospital, Department of Psychiatry, Unit for Psychiatric Research, Mølleparkvej 10, Aalborg 9000, Denmark; ren{at}

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Bipolar disorder is most often severe and recurrent, requiring pharmacological maintenance treatment in combination with psychoeducation and/or other interventions.1 Evidence for the efficacy and tolerability of pharmacological treatment is primarily based on randomised controlled trials (RCTs). However, RCTs are usually characterised by a relatively short duration of follow-up and by relatively small sample sizes. Therefore, for detecting and evaluating rare and long-term side effects, large observational cohort studies have been conducted. Even though selection bias and confounding cannot be avoided in non-randomised studies, various approaches in terms of design and analysis are available for balancing the comparative groups and/or for confounder control, for example, case–control design, use of propensity score models or use of multivariate regression analysis.


A study population of patients diagnosed with bipolar disorder in The Health Improvement Network database receiving at least one 28-day prescription of lithium, valproate, …

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  • Competing interests RE Nielsen has received research grants from H Lundbeck for clinical trials, received speaking fees from Bristol-Myers Squibb, Astra Zeneca, Janssen & Cilag, Lundbeck, Servier, Otsuka Pharmaceuticals and Eli Lilly and has acted as advisor to Astra Zeneca, Eli Lilly, Lundbeck, Otsuka Pharmaceuticals, Takeda and Medivir.

  • RW Licht has received grant from GlaxoSmithKline for clinical trial, received speaker fees from Eli Lilly, Janssen-Cilag, Bristol-Myers Squibb, Pfizer, Astra-Zeneca, Lundbeck, GlaxoSmithKline, Otsuka, Servier and has acted as advisor for Bristol-Myers Squibb, Astra Zeneca, Janssen-Cilag, Otsuka, Eli Lilly and MSD.

  • Provenance and peer review Commissioned; internally peer reviewed.