|LETTER TO THE EDITOR
|Year : 2021 | Volume
| Issue : 2 | Page : 176-177
Randomized trial of vilazodone versus sertraline in depression: concerns and comments
Samir Kumar Praharaj
Department of Psychiatry, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India
|Date of Submission||04-Mar-2021|
|Date of Decision||26-May-2021|
|Date of Acceptance||26-Apr-2021|
|Date of Web Publication||26-May-2021|
Dr. Samir Kumar Praharaj
Department of Psychiatry, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal - 576104, Karnataka
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Praharaj SK. Randomized trial of vilazodone versus sertraline in depression: concerns and comments. Indian J Pharmacol 2021;53:176-7
Bathla and Anjum reported results of a randomized trial comparing vilazodone and sertraline in depression. They found both the drugs to be equally effective for depressive symptoms, whereas vilazodone had an advantage in terms of sexual adverse effects and weight gain. However, there are several concerns regarding the conduct of the study.
As mentioned in the study, a total of 71 patients were recruited, of which 11 “did not complete the second follow-up assessment.” It appears that 71 patients were randomized and received treatment; however, only results of 60 completers are presented. The figure representing the flow of participants is confusing. Ideally, all patients randomized into treatment should be included in the analysis, i.e., to conduct an intent-to-treat analysis.
It mentions that the second author of the study performed a randomization procedure, prescribed the treatment to the patients, and carried out all the assessments. Hence, it is unlikely that allocation concealment and blinding were ensured in the study. A small block size of four also makes the allocation predictable.
Inclusion criteria mention including only married patients of 21 years and above; the reason for the same is unclear. This can affect the generalizability of the findings. Furthermore, “patients who were not taking any psychotropic medication for the past 3 months at least” are not “drug naïve,” but refers to “drug-free” patients. There was no mention of the study's primary outcome, and no a priori sample size estimation was done. It is unclear from the description whether the patients received treatment for 3 months or 6 months as part of the study. The actual dosage of medications received by the patients is not mentioned. The Chi-square test should not be done when there are zero values in cells; instead, a Fisher's exact test is more appropriate.
Almost one-third of the patients in the sertraline group had mild depression, which could have affected the results through a possible “floor effect.” Other illness characteristics of the sample such as the age of onset, duration of depressive episode, family history were not reported. Although it was a randomized clinical trial, the protocol was not registered in any trial registry.
It is recommended that CONSORT guideline is followed while conducting and reporting any clinical trial to improve the quality and transparency. Furthermore, all protocols should be registered prospectively in the trial registry and accessible to readers.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| » References|| |
Bathla M, Anjum S. A 12-week prospective randomized controlled comparative trial of vilazodone and sertraline in Indian patients with depression. Indian J Pharmacol 2020;52:10-5. [Full text]
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al.
CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:e1-37.