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Adjunctive antidepressant therapy is commonly used to treat acute bipolar
depression but few studies have examined this strategy.
To examine the efficacy of agomelatine v. placebo as
adjuncts to lithium or valproate in bipolar depression.
Patients who were currently depressed despite taking lithium or valproate
for at least 6 weeks were randomised to treatment with agomelatine
(n = 172) or placebo (n = 172) for 8
weeks of acute therapy and 44 weeks of continuation therapy (trial
No significant differences in improvement of depressive symptoms were
observed between the two groups either at 8 weeks or 52 weeks on the
primary efficacy measure of change in Montgomery–Åsberg Depression Rating
Scale scores from baseline to end-point. Adverse events including
switches into mania/hypomania were low and similar in both groups.
Agomelatine adjunctive therapy was not superior to placebo adjunctive
therapy for acute bipolar depression.
The present trial informs clinicians about switching conditions with the antidepressant agomelatine after the failure of a treatment with either paroxetine or venlafaxine.
The total number of discontinuation-emergent symptoms, according to the Discontinuation-Emergent Signs and Symptoms checklist, was compared in double-blind conditions after 3 switching options: immediate substitution or initiation of agomelatine (25 mg/day p.o.) with either a short- or long-tapering of the previous drug. Secondary objectives included tolerability and safety assessments and the early clinical benefit after the switch.
For all switching options, a withdrawal syndrome was observed 1 week after cessation of the selective serotonin reuptake inhibitor (SSRI)/serotonin–norepinephrine reuptake inhibitor (SNRI) treatment. Psychic symptoms were the most frequently reported, and somatic symptoms were comparatively few. Early discontinuation symptoms after cessation of SSRI/SNRI treatment did not prejudice the antidepressant benefits of agomelatine over 8 weeks.
Both abrupt and start–taper switching with agomelatine are options in everyday practice for those patients who have not responded to either paroxetine or venlafaxine. However, regardless of the switching strategy, the present double-blind study shows that early discontinuation symptoms that arise upon cessation of SSRI/SNRI can alter the patients’ perception of the clinical benefit of the new antidepressant. Both practitioners and patients must be warned about these early discontinuation symptoms to prevent the symptoms from being confounded with a lack of therapeutic benefit of the new treatment.
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