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2013 ; 17
(54
): 1-190
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Lithium or an atypical antipsychotic drug in the management of
treatment-resistant depression: a systematic review and economic evaluation
#MMPMID24284258
Edwards SJ
; Hamilton V
; Nherera L
; Trevor N
Health Technol Assess
2013[Nov]; 17
(54
): 1-190
PMID24284258
show ga
BACKGROUND: Patients with treatment-resistant depression (TRD) are those with
major depressive disorder that has not responded adequately to treatment. The
causes of depression are not fully understood, although there is evidence to
suggest that depression is a complex interaction among biological, genetic,
psychosocial and environmental factors. Strategies available for the treatment of
patients with TRD include pharmacological, non-pharmacological, and psychological
and psychosocial interventions. Pharmacological treatment options include
switching to a different antidepressant, the addition of another antidepressant
of a different class, or use of an augmenting agent, such as anticonvulsants,
lithium or atypical antipsychotics (AAPs). However, there is limited evidence
available on the effectiveness of these strategies in the treatment of TRD.
OBJECTIVES: To estimate the clinical effectiveness and cost-effectiveness of
augmentation of selective serotonin reuptake inhibitor (SSRI) antidepressant
therapy with either lithium or an AAP drug in the management of people with
treatment-resistant unipolar depression, defined as failure to respond to two or
more antidepressant drugs in their current episode of depression. DATA SOURCES:
Databases searched were Cochrane Central Register of Controlled Trials (CENTRAL),
EMBASE, MEDLINE, PsycINFO and NHS Economic Evaluation Database (NHS EED). All
databases were searched from inception to August 2011. Additional data were
obtained from manufacturers. REVIEW METHODS: Systematic reviews of studies
evaluating clinical effectiveness, economic analyses and quality of life (QoL)
were executed. Quality assessment according to predefined criteria was undertaken
independently by two reviewers. Pairwise meta-analyses and mixed-treatment
comparisons (MTCs) using both fixed- and random-effects models were undertaken
based on intention-to-treat analyses. A probabilistic de novo mathematical model
was developed to synthesise the available data on costs and clinical outcomes
from the UK NHS perspective over a 1-year time horizon (8 weeks of acute
treatment captured by a decision tree and 10 months of maintenance treatment
captured by a Markov model). RESULTS: Twelve randomised controlled trials (RCTs)
were identified in the review of clinical effectiveness literature; 10 considered
SSRI??+??AAP compared with SSRI??+??placebo/no treatment, one considered
SSRI??+??AAP compared with SSRI??+??lithium and one considered SSRI??+??lithium
compared with SSRI??+??placebo. The RCTs included in the primary analyses used
fluoxetine as the background SSRI and olanzapine as the AAP. Results of the MTC
showed a non-significant trend in favour of lithium augmentation for response
[lithium a priori odds ratio (OR) 1.29; 95% credible interval (CrI) 0.11 to 5.32;
lithium post hoc OR 4.15; 95% CrI 0.25 to 20.34 (the trial informing the
comparison with lithium reported response using two different definitions)], mean
change in Montgomery-Åsberg Depression Rating Scale score from baseline (mean
difference -??1.47, 95% CrI -??9.10 to 6.41) and all-cause withdrawals (OR 0.74,
95% CrI 0.10 to 2.66). Four economic evaluations (none directly addressing the
review question) and 17 studies that reported on QoL were identified and
summarised in narrative reviews. The results of the de novo modelling indicate
that augmentation of SSRI with lithium dominates augmentation of an SSRI with AAP
(i.e. it resulted in cost savings of £905 per person per year and generated more
health benefits, estimated to be 0.03 quality-adjusted life-years). However,
sensitivity analyses showed that the model was highly sensitive to changes in
acute treatment efficacy (response and remission) or discontinuation. The model
was not sensitive to changes in other parameters. LIMITATIONS: In patients with
TRD, there is a lack of direct evidence comparing the clinical effectiveness of
augmenting an SSRI with an AAP compared with augmenting with lithium. RCTs were
identified which facilitated comparison of adding AAP with adding lithium via a
MTC. However, variations in the definitions of response implemented in the RCTs,
together with differences in patient baseline characteristics across RCTs,
introduce bias into the analysis. The direction and extent of the bias is
uncertain. CONCLUSIONS: Augmentation of SSRIs with lithium or AAP is likely to be
beneficial in people with TRD. Clinical evaluation based on the limited evidence
identified in this research indicates no statistically significant difference
between the two augmentation strategies. Cost-effectiveness analyses suggest that
augmentation with lithium is less expensive and more effective than augmentation
with AAP. However, the uncertainty in the clinical estimates of discontinuation
and treatment response is reflected in the model results. A RCT comparing the two
augmentation strategies, reporting relevant outcomes, including QoL, is needed.
STUDY REGISTRATION: PROSPERO CRD42011001464.
|*Outcome Assessment, Health Care
[MESH]
|*Quality-Adjusted Life Years
[MESH]
|Adult
[MESH]
|Antidepressive Agents/adverse effects/economics/therapeutic use
[MESH]
|Antipsychotic Agents/adverse effects/economics/*therapeutic use
[MESH]
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