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Adding ziprasidone to escitalopram effective for persistent depression in MDD
Results from an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial suggest that as an adjunct to escitalopram, ziprasidone was an effective antidepressant for patients with major depressive disorder who experienced persistent depressive symptoms after receiving Lexapro for 8 weeks.
“Our group previously conducted and published the results of an open-label ziprasidone augmentation study for treatment-resistant major depression. In that study, 10 of 20 patients with major depressive disorder who failed to respond to an adequate therapeutic trial of a selective serotonin reuptake inhibitor (SSRI) had a positive antidepressant response after 6 weeks of treatment with ziprasidone in addition to their SSRI,” study researcher George I. Papakostas, MD, of Massachusetts General Hospital, and colleagues wrote. “To our knowledge, these promising but preliminary results have not yet been confirmed in a randomized trial.”
George I. Papakostas
Researchers conducted the current randomized clinical trial on ziprasidone as an antidepressant in two phases. In phase one, 139 outpatients with major depressive disorder received 10 mg of escitalopram daily for 8 weeks. In phase two, patients with persistent symptoms were randomly assigned to either adjunctive ziprasidone 20 mg (n = 71) or placebo (n = 68) twice daily for 8 weeks.
Study researchers could increase dosage of the study drug in one capsule, twice daily, weekly increments, yielding a potential ziprasidone dosage range of 20 mg to 80 mg twice daily.
Approximately 35.2% of patients who received escitalopram plus ziprasidone had a clinical response, compared with 20.5% of patients who received escitalopram plus placebo.
Mean improvement in Hamilton Depression Rating Scale scores were higher among patients who received escitalopram plus ziprasidone vs. those who received placebo (–6.4 vs. –3.3).
Additionally, patients who received escitalopram plus ziprasidone had greater improvement in Hamilton Anxiety Rating scale scores (–3.5 vs. –1.5) but not in Visual Analog Scale for Pain scores, compared with those who received placebo.
Ten patients discontinued ziprasidone because of intolerance, while none of the patients receiving placebo discontinued treatment.
Patients who received ziprasidone reported higher rates of somnolence/fatigue, irritability, anxiety/agitation and muscle twitching compared with the placebo group.
“In conclusion, in the present study, ziprasidone used adjunctively with the SSRI escitalopram demonstrated greater antidepressant efficacy in patients with major depressive disorder compared with adjunctive placebo. A statistically significantly greater proportion of patients discontinued adjunctive ziprasidone due to intolerance,” Papakostas and colleagues wrote. “These results suggest that, similar to other atypical antipsychotic agents, adjunctive ziprasidone can represent a useful treatment option for patients with major depressive disorder.” – by Amanda Oldt
Disclosure: Papakostas has received research support from and/or served as a consultant or speaker for Abbott, AstraZeneca, Avanir, Brainsway, Bristol-Myers Squibb, Cephalon, Dey Pharma, Eli Lilly, Forest, Genentech, GlaxoSmithKline, Evotec AG, Lundbeck, Inflabloc, Janssen Global Services, Jazz Pharmaceuticals, Johnson and Johnson, NIMH, Novartis, One Carbon Therapeutics, Otsuka, Pamlab, Pfizer, Pierre Fabre, Ridge Diagnostics, Shire, Sunovion, Takeda, Theracos, Titan Pharmaceuticals and Wyeth. Please see the full study for a list of all other authors’ relevant financial disclosures.