Related Experiment Video
Updated: Aug 16, 2026
10:17
The Tail Suspension Test
Published on: January 28, 2012
Re-evaluation of randomized control trials of lithium monotherapy: a cohort effect
D Deshauer1, D Fergusson, A Duffy
1Department of Psychiatry, University of Ottawa, Bipolar Disorders Research Unit, Royal Ottawa Hospital, Ottawa, ON, Canada. deshauer1@sympatico.ca
Bipolar Disorders
|July 20, 2005
Summary
Lithium maintenance therapy for bipolar disorder is affected by study design. Pre-randomization enrichment and diagnostic changes influence randomized controlled trial (RCT) outcomes, impacting lithium
Area of Science:
- Psychiatry and Mental Health
- Clinical Trials Methodology
- Pharmacological Research
Background:
- Lithium's efficacy in bipolar disorder prophylaxis has shown variability.
- Factors like diagnostic changes and study design heterogeneity are implicated.
- Quantifying the impact of specific methodological elements is crucial for interpreting lithium trial results.
Purpose of the Study:
- To assess the influence of pre-randomization enrichment designs on lithium maintenance randomized controlled trials (RCTs).
- To evaluate the effect of diagnostic drift on the interpretation of lithium's efficacy in bipolar disorder.
- To provide a clearer understanding of methodological factors affecting lithium monotherapy research.
Main Methods:
- Searched MEDLINE, EMBASE, and PSYCHINFO (1966-2004) for RCTs of lithium maintenance therapy in bipolar disorder.
- Included studies with a minimum 1-year duration, lithium and placebo arms.
- Excluded superiority trials without placebo, discontinuation, and mirror image studies.
Main Results:
- Nine RCTs (1432 patients) were analyzed, with 705 pre-randomization dropouts.
- Non-enriched trials (RDC/Feighner criteria) showed pooled odds of 3.2:1 favoring lithium.
- Lithium-enriched trials (excluding atypical bipolar disorder) demonstrated pooled odds of 22.0:1 favoring lithium.
- Trials using DSM-IV criteria and lamotrigine enrichment showed pooled odds of 1.9:1.
Conclusions:
- Randomized controlled trials for lithium maintenance therapy exhibit significant variability in patient selection and design.
- Pre-randomization enrichment phases introduce a cohort effect, influencing study outcomes.
- Diagnostic drift also contributes to variability, complicating direct comparisons of lithium monotherapy efficacy over time.
Related Concept Videos
01:30Electroconvulsive Therapy
Electroconvulsive therapy (ECT), or shock therapy, remains a critical biomedical intervention for severe, treatment-resistant depression. While its origins can be traced back to Hippocrates' observations that malaria-induced convulsions alleviated mental illness, modern ECT has evolved significantly from its earlier, more primitive applications. First introduced in 1938 by Ugo Cerletti and his colleagues, ECT involves inducing controlled seizures using electrical currents. In its early years,...
01:29Therapeutic Drug Monitoring: Affecting Factors
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.