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Proposal 1148

Title of the Proposed Research

Meta-analysis of the risk of relapse in bipolar disorder

Lead Researcher

Dr. Joaquim Radua

Affiliation

FIDMAG Germanes Hospitalàries

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

29 Jan 2015

Lay Summary

Unfortunately, relapse rates in bipolar disorder differ significantly between studies and it is not clear whether differences exist depending on disorder type or presence of subsyndromal symptoms.

We will report the first meta-analysis of naturalistic studies assessing the relapse rate in bipolar disorder. Other aims of the project are to assess whether e.g. the type of disorder or the presence of subsyndromal symptoms are risk factors for relapses.

For this meta-analysis, most data have been already retrieved from major databases plus manual searches within review papers and reference sections of individual papers. Individual patient relapse data were recreated from Kaplan-Meier plots or obtained from the authors and meta-analyzed using survival models, i.e. the appropriate statistical analysis for assessing relapses. To consolidate preliminary results, we want to add the data from "F1D-EW-HGKV-A European observational study of health outcomes associated with treatment for mania in Bipolar Disorder."

Data from this meta-analysis will provide reliable estimations of the risk of relapse in bipolar disorder to patients, clinicians and researchers.

The meta-analysis will be published in a high impact-factor international psychiatry journal.

Study Data Provided

Study F1D-EW-HGKV: A European observational study of health outcomes associated with treatment for mania in Bipolar Disorder.

Statistical Analysis Plan

The risk of relapse will be estimated from survival tables as the risk of relapse during the next 12 months, the risk of relapse during the next 5 years, and the median time to relapse.

The effects of the variables will be estimated from Cox regressions as hazard ratios, including covariates as appropriate.

Publication Citation

Radua et al. Meta-analysis of the risk of subsequent mood episodes in bipolar disorder. Psychotherapy and Psychosomatics, in Press. DOI: 10.1159/000449417