Abstract
BackgroundPatients with major depression refractory to repeated pharmacological trials (TRD) may remain symptomatic for many years after their index episode. Augmentation strategies (with lithium or an atypical antipsychotic) or combining an antidepressant with short-term psychotherapy have been used with relative success in these patients. The aim of this study was to assess the effectiveness of the concomitant administration of quetiapine, an atypical antipsychotic, or placebo, to cognitive-behavior therapy (CBT) in TRD.MethodsThirty-one patients who met entrance criteria for unipolar major depression (TRD stage II or greater) underwent 3 weeks of lithium augmentation after which non-responders (N = 22) were randomized to receive either quetiapine or placebo as an adjunct to their 12 weekly CBT sessions (quetiapine/CBT or placebo/CBT groups). Primary efficacy measures were the Hamilton and the Montgomery-Asberg rating scales for depression.ResultsOverall, there was a significant reduction in both primary efficacy measure scores at LOCF for the 11 patients in the quetiapine/CBT group but not in the placebo/CBT treated patients. Patients in the quetiapine/CBT group, compared to those receiving placebo/CBT, showed a significantly greater degree of improvement on one primary and one secondary efficacy measure, were more likely to complete the trial and, completed a greater number of CBT sessions.ConclusionAlthough preliminary, our results suggest that the adjunctive administration of quetiapine to CBT may prove useful in the treatment of stage II TRD.Trial RegistrationCurrent Controlled Trials ISRCTN12638696.
Highlights
Patients with major depression refractory to repeated pharmacological trials (TRD) may remain symptomatic for many years after their index episode
Of note is a prior history of electroconvulsive treatment (2 patients, one in each randomized group) suggesting that some patients had greater than stage II refractory depression
Patient sub-samples were not significantly different with regards sex, age, duration of illness, prior antidepressant treatment and initial rating scale scores from the pooled values of the 31 patients initially screened for the study
Summary
Patients with major depression refractory to repeated pharmacological trials (TRD) may remain symptomatic for many years after their index episode. Augmentation strategies (with lithium or an atypical antipsychotic) or combining an antidepressant with short-term psychotherapy have been used with relative success in these patients. Many depressed patients fail to respond to an adequate treatment with a single or, to several antidepressant trials, constituting what can be generally termed treatment refractory depression (TRD) [1]. The 'Sequenced Treatment Alternatives to Relieve Depression (STAR*D)' study has shown that only 50 to 55% of patients attain remission, defined by a Hamilton Rating Scale for Depression (page number not for citation purposes). Augmentation (with lithium carbonate or an atypical antipsychotic), switching to an antidepressant from a different class, combining several different antidepressants or an antidepressant with short-term psychotherapy, has been used with relative success in these patients [2,3,4,5,6,7,8,9]. Stage II TRD for instance is defined by the failure of two prior antidepressant treatments, each from a different class [1,10]
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