Clinical relevance of vilazodone treatment in patients with major depressive disorder: categorical improvement in symptoms

Larry Culpepper, Maju Mathews, Razi Ghori, John Edwards, Larry Culpepper, Maju Mathews, Razi Ghori, John Edwards

Abstract

Objective: To assess clinically relevant symptom improvement in patients with major depressive disorder (MDD) receiving vilazodone by using the Montgomery-Asberg Depression Rating Scale (MADRS), a clinician-rated scale used to measure MDD symptom severity and improvement.

Method: Pooled data from 2 positive, phase 3, 8-week, double-blind, randomized, placebo-controlled trials in patients with MDD were analyzed. Patients received vilazodone 40 mg/d or placebo; post hoc analyses were conducted on study completers. Depression symptom improvement was evaluated by analyzing the proportions of patients who shifted from the baseline MADRS single-item symptom severity category of ≥ 2 (mild to severe symptoms) to an end-of-study category < 2 (minimal to no symptoms) or from ≥ 4 (moderate to severe symptoms) to ≤ 2 (mild to no symptoms). The proportion of patients who shifted from anxious depression to no anxious depression was also analyzed.

Results: The percentage of patients who completed these studies with severity category shift from baseline ≥ 2 to end of study < 2 was significantly higher for vilazodone versus placebo on all MADRS items (odds ratio [OR] range, 1.4-1.7, P < .05) except reduced appetite (OR = 1.3, P = .232). A significantly greater proportion of vilazodone-treated versus placebo-treated patients shifted from baseline ≥ 4 to end of study ≤ 2 on MADRS items of apparent sadness, reported sadness, inner tension, reduced sleep, and lassitude (OR range, 1.5-2.0, P < .05). Additionally, a significantly greater proportion of vilazodone-treated versus placebo-treated patients shifted from anxious depression at baseline to no anxious depression at end of study (OR = 1.5, P = .031).

Conclusions: These results suggest that vilazodone treatment is associated with clinically relevant changes in depression symptoms in patients with MDD.

Trial registration: ClinicalTrials.gov identifiers: NCT00285376 and NCT00683592.

Figures

Figure 1.
Figure 1.
Proportion of Patients With Montgomery-Asberg Depression Rating Scale (MADRS) Single-Item Scores ≥ 2 (mild to severe) or ≥ 4 (moderate to severe) at Baseline (completer population, n = 694)
Figure 2.
Figure 2.
Categorical Improvement: Baseline Montgomery-Asberg Depression Rating Scale (MADRS) Single-Item Score ≥ 2 to P < .05 vs placebo. **P < .01 vs placebo. ***P < .001 vs placebo.
Figure 3.
Figure 3.
Categorical Improvement: Baseline Montgomery-Asberg Depression Rating Scale (MADRS) Single-Item Score ≥ 4 to ≤ 2 at End of Study (completer population, n = 694)a aThe suicidal thoughts item (item 10) was not evaluable due to low number of observations (placebo = 3, vilazodone = 4). *P < . 05 vs placebo. **P < .01 vs placebo.

References

    1. Goodwin RD, Kroenke K, Hoven CW, et al. Major depression, physical illness, and suicidal ideation in primary care. Psychosom Med. 2003;65(4):501–505.
    1. Leon AC, Olfson M, Broadhead WE, et al. Prevalence of mental disorders in primary care: implications for screening. Arch Fam Med. 1995;4(10):857–861.
    1. Spitzer RL, Kroenke K, Linzer M, et al. Health-related quality of life in primary care patients with mental disorders: results from the PRIME-MD 1000 Study. JAMA. 1995;274(19):1511–1517.
    1. Daly EJ, Trivedi MH, Wisniewski SR, et al. Health-related quality of life in depression: a STAR*D report. Ann Clin Psychiatry. 2010;22(1):43–55.
    1. Katon W, Lin EH, Kroenke K. The association of depression and anxiety with medical symptom burden in patients with chronic medical illness. Gen Hosp Psychiatry. 2007;29(2):147–155.
    1. Katon WJ. Clinical and health services relationships between major depression, depressive symptoms, and general medical illness. Biol Psychiatry. 2003;54(3):216–226.
    1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Text Revision. Fourth Edition. Washington, DC: American Psychiatric Association; 2000.
    1. Fava M, Rush AJ, Alpert JE, et al. Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR*D report. Am J Psychiatry. 2008;165(3):342–351.
    1. Fava M, Rush AJ, Alpert JE, et al. What clinical and symptom features and comorbid disorders characterize outpatients with anxious major depressive disorder: a replication and extension. Can J Psychiatry. 2006;51(13):823–835.
    1. Trivedi MH, Rush AJ, Wisniewski SR, et al. STAR*D Study Team Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006;163(1):28–40.
    1. Khan A, Cutler AJ, Kajdasz DK, et al. A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder. J Clin Psychiatry. 2011;72(4):441–447.
    1. Rickels K, Athanasiou M, Robinson DS, et al. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70(3):326–333.
    1. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134(4):382–389.
    1. Robinson DS, Kajdasz DK, Gallipoli S, et al. A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder. J Clin Psychopharmacol. 2011;31(5):643–646.
    1. Liebowitz M, Croft HA, Kajdasz DK, et al. The safety and tolerability profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Psychopharmacol Bull. 2011;44(3):1–19.
    1. Clayton AH, Kennedy SH, Edwards JB, et al. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013;10(10):2465–2476.
    1. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23(1):56–62.
    1. Gaynes BN, Rush AJ, Trivedi MH, et al. Major depression symptoms in primary care and psychiatric care settings: a cross-sectional analysis. Ann Fam Med. 2007;5(2):126–134.
    1. Mark TL, Levit KR, Buck JA. Datapoints: psychotropic drug prescriptions by medical specialty. Psychiatr Serv. 2009;60(9):1167.
    1. Gaynes BN, Rush AJ, Trivedi MH, et al. Primary versus specialty care outcomes for depressed outpatients managed with measurement-based care: results from STAR*D. J Gen Intern Med. 2008;23(5):551–560.
    1. Judd LL, Akiskal HS, Maser JD, et al. Major depressive disorder: a prospective study of residual subthreshold depressive symptoms as predictor of rapid relapse. J Affect Disord. 1998;50(2–3):97–108.
    1. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905–1917.
    1. Fava M. Pharmacological approaches to the treatment of residual symptoms. J Psychopharmacol. 2006;20(suppl):29–34.
    1. Menza M, Marin H, Opper RS. Residual symptoms in depression: can treatment be symptom-specific? J Clin Psychiatry. 2003;64(5):516–523.
    1. Rao S, Zisook S. Anxious depression: clinical features and treatment. Curr Psychiatry Rep. 2009;11(6):429–436.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera