Abstract

Objectives

To evaluate the baseline characteristics and follow-up outcomes of rapid-cycling (RC) bipolar I patients in a large, prospective, observational study.

Methods

EMBLEM (European Mania in Bipolar Longitudinal Evaluation of Medication) is a long-term prospective observational study of in- and outpatients with an acute mania/mixed episode conducted in 14 European countries.

Demographic and clinical variables were collected at baseline, including the presence or absence of DSM-IV rapid-cycling during the past year. Outcome measures included the 5-item Hamilton Depression Rating Scale (HAMD-5) and Young Mania Rating Scale (YMRS) over 12 weeks, as well as the Clinical Global Impressions-Bipolar Disorder Scale (CGI-BP overall, mania and depression) over 12 months.

Results

Of 3684 patients enrolled, 3089 patients provided reliable data to qualify for either RC (N = 535, 17.3%) or non-RC (NRC, N = 2554), according to DSM-IV. RC prevalence varied across countries (p < 0.001). Baseline and 12 week outcomes on the YMRS and HAMD-5, 12 month ratings on the CGI-BP subscales and work impairment at 12 months were significantly different (p < 0.001) between groups, being worse in RC. RC patients were more likely to receive antidepressants and lamotrigine (p < 0.001). Using logistic regression, RC was associated to country (p < 0.001), female sex (p = 0.029), outpatients (p = 0.035), more history of attempted suicide (p < 0.001) and alcohol abuse (p < 0.001).

Conclusions

The EMBLEM results suggest that in naturalistic settings, patients with mania and RC differ from NRC in socio-demographic characteristics, treatment prescriptions and clinical outcome measures with a consistently worse occupational outcome and comorbidities. RC represents a longitudinally severe form of bipolar disorder, with poorly evidence-based diagnostic and therapeutic tools.

Keywords: Rapid-cycling; Bipolar I; Mania; Observational study

Article Outline

1. Introduction

2. Method

2.1. Study design and patients

2.2. Medication

2.3. Assessments

2.4. Statistical analyses

3. Results

3.1. Baseline patient characteristics

3.2. Clinical ratings at baseline

3.3. Patterns of medication

3.4. Factors associated with RC condition at baseline

3.5. Outcome

4. Discussion

Authorship

Role of funding source

Conflict of interest

Acknowledgements

References