Jakarta, 28 May 2010
Efficacy of Abilify in depressive patients with anxious or atypical features
Efficacy of Abilify in depressive patients with anxious or atypical features
Unresolved or residual symptoms are common among individuals treated for major depressive disorder (MDD) and are associated with an increased risk of relapse and poor psychosocial functioning.
When first-line strategies are ineffective, clinicians frequently switch antidepressants or use an augmentation agent.
Several augmentation and combination strategies have been used to try to improve outcomes in patients who show an inadequate response to antidepressant treatment.
Treatment is further complicated by the heterogenety of the syndrome. Specifically, there are several clinically relevant subtypes of depression that do not respond uniformly to standard antidepressant treatments.
For example, significant proportions of patients with MDD manifest anxious or atypical features or both.
Depending on the clinical criteria used, up to 46% of MDD patients meet criteria for anxious depression" and up to 36% of patients have atypical features.
These subtypes may also be associated with poorer long-term prognosis. For example, anxious depression has been shown to be associated with greater symptom severity, suicidality, worse functioning, and poorer acute outcomes."!
Furthermore, depression with atypical features may also show a differential response to treatment. Atypical depression was less responsive to tricyclic antidepressants than monoamine oxidase inhibitors.
Since remission is the goal for treatment, there is a need for better understanding of medications that can improve and remit core depressive symptoms such as sadness, lack of energy/fatigue, lack of interest, and inability to enjoy daily activities in these difficult to treat populations with anxious or atypical features.
Objective: To evaluate the efficacy of adjunctive Abilify to standard antidepressant therapy (ADT) for patients with DSM-IV major depressive disorder with anxious/atypical features at baseline.
Method: Data from 2 identical 14-week studies (an 8-week prospective ADT treatment phase and a 6-week randomized, double-blind phase) of Abilify augmentation were pooled to evaluate efficacy and safety in the 2 subgroups.
The primary efficacy endpoint was mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from end of ADT treatment to end of randomized treatment (last observation carried forward).
Anxious depression was defined by a Hamilton Rating Scale for Depression anxiety/somatization factor score > 7, and atypical depression was defined by previously described criteria on the Inventory of Depressive Symptomatology-Self-Report.
Both anxious and atypical subtypes were defined based on symptoms at entry into prospective ADT (week 0).Patients were enrolled between June 2004 and April 2006 in one study and from September 2004 to December 2006 in the other (total randomized population, N =742; anxious/nonanxious population, N = 740; atypical/nonatypical population, N = 737).
Results: Completion rates were between 84% and 90% and comparable across all subgroups, with low discontinuations due to adverse events.
Patients receiving adjunctive Abilify demonstrated significantly greater improvement in MADRS total score versus patients receiving adjunctive placebo, starting at week 1 or week 2 and continuing through to endpoint (anxious: -8.72 vs. -6.17, p s .001; nonanxious: -8.61 vs. -4.97, p s .001; atypical: -9.31 vs. -5.15, p s .001; nonatypical: -8.08 vs. -6.22, p < .05).
At endpoint, remission rates were also significantly higher with adjunctive Abilify versus adjunctive placebo (p < .05) in all subgroups.
Treatment emergent adverse event profile was similar in all subgroups and comparable to the total population. Reporting of akathisia and weight gain on Abilify treatment did not differ between subgroups.
Conclusion: Adjunctive Abilify is an effective treatment for patients with major depression presenting with either anxious or atypical features.
Reference :
Madhukar H. Trivedi, Adjunctive Aripiprazole in Major Depressive Disorder:Analysis of Efficacy and Safety in Patients With Anxious and Atypical Features(J Clin Psychiatry 2008;69:1928-1936)
Elizabeth Jonosewojo, MD
Ass. Medical Director
elizabet@ho.otsuka.co.id
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