Limits...
Profile of vortioxetine in the treatment of major depressive disorder: an overview of the primary and secondary literature.

Kelliny M, Croarkin PE, Moore KM, Bobo WV - Ther Clin Risk Manag (2015)

Bottom Line: This article reviews the pharmacological profile and available efficacy and tolerability/safety data for vortioxetine, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults.Nevertheless, effectiveness studies that directly compare the clinical effects of vortioxetine with other established antidepressant drugs are lacking, and there is no evidence as yet that vortioxetine is more clinically effective than other types of antidepressants.Some preliminary suggestions concerning the place of vortioxetine among the broad range of pharmacological treatments for adults with MDD are provided.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA.

ABSTRACT
This article reviews the pharmacological profile and available efficacy and tolerability/safety data for vortioxetine, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults. The efficacy of vortioxetine for treating MDD in adults is supported by eight positive short-term (6- to 12-weeks) randomized, placebo-controlled trials, and one positive randomized, double-blind, 52-week relapse prevention trial. Based on pooled data from short-term randomized trials and from longer-term studies, vortioxetine appears to be well tolerated and to have a low incidence of adverse effects on sexual functioning. Vortioxetine also appears to be effective for treating symptoms of MDD in the elderly based on the results of one randomized trial for which recruitment was focused on this specific population. Nevertheless, effectiveness studies that directly compare the clinical effects of vortioxetine with other established antidepressant drugs are lacking, and there is no evidence as yet that vortioxetine is more clinically effective than other types of antidepressants. Some preliminary suggestions concerning the place of vortioxetine among the broad range of pharmacological treatments for adults with MDD are provided.

No MeSH data available.


Related in: MedlinePlus

Estimated risk of bias of reviewed studies.Note: The figure gives a summary of an assessment of overall risk of bias across 12 published studies of vortioxetine for treating major depressive disorder in adults, using the Cochrane Risk of Bias Assessment tool.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4542474&req=5

f1-tcrm-11-1193: Estimated risk of bias of reviewed studies.Note: The figure gives a summary of an assessment of overall risk of bias across 12 published studies of vortioxetine for treating major depressive disorder in adults, using the Cochrane Risk of Bias Assessment tool.

Mentions: All short-term, acute-phase studies of vortioxetine for treating adults with MDD used fixed-dose, parallel-group designs, and enrolled patients with no evidence of treatment-resistant depression (generally defined as having failed to respond to two adequate antidepressant treatments of at least 6 weeks’ duration).49–59Table 2 highlights the considerable variability between studies with respect to type of study participants, treatment settings, minimum severity of depressive symptoms for inclusion in the study (Montgomery-Åsberg Depression Rating Scale [MADRS] total scores 22–30), vortioxetine doses (2.5–20 mg daily), and length of follow-up (6–12 weeks). One published positive study compared the clinical effects of flexibly dosed vortioxetine and agomelatine in patients who did not respond adequately to SSRIs or serotonin-norepinephrine reuptake inhibitors (SNRIs).56 One study focused exclusively on elderly adults (aged ≥65 years).51 Only eleven of the 14 reviewed studies were published at the time of review. The risk of bias was assessed as being low or unclear across the nine published studies as determined using the Cochrane Risk of Bias Assessment tool (Figure 1). Three studies were assessed as having low bias risk in all domains.49,51,56 Although the bias risk assessment was generally low across studies for randomization sequence generation, allocation concealment, and selective outcome reporting, the presence of bias in other domains (including masking of clinical raters) cannot be excluded. There was insufficient methodological detail for the unpublished studies, as posted on www.ClinicalTrials.gov, to permit a thorough risk of bias assessment.


Profile of vortioxetine in the treatment of major depressive disorder: an overview of the primary and secondary literature.

Kelliny M, Croarkin PE, Moore KM, Bobo WV - Ther Clin Risk Manag (2015)

Estimated risk of bias of reviewed studies.Note: The figure gives a summary of an assessment of overall risk of bias across 12 published studies of vortioxetine for treating major depressive disorder in adults, using the Cochrane Risk of Bias Assessment tool.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4542474&req=5

f1-tcrm-11-1193: Estimated risk of bias of reviewed studies.Note: The figure gives a summary of an assessment of overall risk of bias across 12 published studies of vortioxetine for treating major depressive disorder in adults, using the Cochrane Risk of Bias Assessment tool.
Mentions: All short-term, acute-phase studies of vortioxetine for treating adults with MDD used fixed-dose, parallel-group designs, and enrolled patients with no evidence of treatment-resistant depression (generally defined as having failed to respond to two adequate antidepressant treatments of at least 6 weeks’ duration).49–59Table 2 highlights the considerable variability between studies with respect to type of study participants, treatment settings, minimum severity of depressive symptoms for inclusion in the study (Montgomery-Åsberg Depression Rating Scale [MADRS] total scores 22–30), vortioxetine doses (2.5–20 mg daily), and length of follow-up (6–12 weeks). One published positive study compared the clinical effects of flexibly dosed vortioxetine and agomelatine in patients who did not respond adequately to SSRIs or serotonin-norepinephrine reuptake inhibitors (SNRIs).56 One study focused exclusively on elderly adults (aged ≥65 years).51 Only eleven of the 14 reviewed studies were published at the time of review. The risk of bias was assessed as being low or unclear across the nine published studies as determined using the Cochrane Risk of Bias Assessment tool (Figure 1). Three studies were assessed as having low bias risk in all domains.49,51,56 Although the bias risk assessment was generally low across studies for randomization sequence generation, allocation concealment, and selective outcome reporting, the presence of bias in other domains (including masking of clinical raters) cannot be excluded. There was insufficient methodological detail for the unpublished studies, as posted on www.ClinicalTrials.gov, to permit a thorough risk of bias assessment.

Bottom Line: This article reviews the pharmacological profile and available efficacy and tolerability/safety data for vortioxetine, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults.Nevertheless, effectiveness studies that directly compare the clinical effects of vortioxetine with other established antidepressant drugs are lacking, and there is no evidence as yet that vortioxetine is more clinically effective than other types of antidepressants.Some preliminary suggestions concerning the place of vortioxetine among the broad range of pharmacological treatments for adults with MDD are provided.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA.

ABSTRACT
This article reviews the pharmacological profile and available efficacy and tolerability/safety data for vortioxetine, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults. The efficacy of vortioxetine for treating MDD in adults is supported by eight positive short-term (6- to 12-weeks) randomized, placebo-controlled trials, and one positive randomized, double-blind, 52-week relapse prevention trial. Based on pooled data from short-term randomized trials and from longer-term studies, vortioxetine appears to be well tolerated and to have a low incidence of adverse effects on sexual functioning. Vortioxetine also appears to be effective for treating symptoms of MDD in the elderly based on the results of one randomized trial for which recruitment was focused on this specific population. Nevertheless, effectiveness studies that directly compare the clinical effects of vortioxetine with other established antidepressant drugs are lacking, and there is no evidence as yet that vortioxetine is more clinically effective than other types of antidepressants. Some preliminary suggestions concerning the place of vortioxetine among the broad range of pharmacological treatments for adults with MDD are provided.

No MeSH data available.


Related in: MedlinePlus