Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05104918 |
| Other study ID # |
VORSCOT |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 2022 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
November 2021 |
| Source |
Scotmann Pharmaceuticals |
| Contact |
Mehmood ALi |
| Phone |
00923105666079 |
| Email |
lonsa25[@]student.london.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To the best of the knowledge of the Principal Investigators, there was no randomised
controlled trial to assess the potential cognitive improvement seen with Vortioxetine, in
comparison with some other most commonly used SNRI, when used as directed for the treatment
of Major Depressive Disorders. As such the outcome of this trial will provide evidence to
assess this claim in the Pakistani population and determine the clinical efficacy when
compared to some other commonly used anti-depressants. This would be the first randomized
trial dedicated for this assessment in the region with an active control of one of the most
commonly used Selective Serotonin and Norepinephrine Reuptake Inhibitors (SSNRIs) in Pakistan
for the treatment of depression, Venlafaxine. It can be utilized as an alternative to MDD
treatment options, especially where the focus is on improving the cognitive abilities of the
patients.
Description:
What is Known?
Major Depressive Disorder (MDD) is a distressing and highly prevalent condition which affects
the individual's physical, emotional and cognitive well-being, making it one of the leading
causes of disability worldwide.
Rationale:
Among the other symptoms, cognitive dysfunctions are one of the major impacts of this
disorder and sometimes even overshadow the depressive symptoms2. Disturbances in cognitive
functions affect a person's performance in life and work, affecting their concentration,
focus, memory, planning, and decision making. Moreover, lack of sleep and dominant-negative
thoughts associated with depression also make the cognitive ability worse.
Literature review has consistently demonstrated the negative impact on cognitive abilities
affecting the productivity and functioning of individuals with MDD, despite the wide variety
of study designs or locations. Cognitive dysfunctions is one of the most common effects
reported throughout these studies.
Research gap identified:
Despite the repeated emphasis given in literature indicating the pivotal importance of
cognitive abilities on the daily and professional working of humans, this is one domain that
is very rarely studied separately in studies.
Relevance, importance, and applicability:
On September 30, 2013, the Food and Drug Administration approved vortioxetine for the
treatment of adults with MDD. Vortioxetine's precise mechanism of action is unknown. It is
hypothesized that vortioxetine works via blockade of serotonin reuptake; however,
vortioxetine is pharmacologically different than other SSRIs because it also works by direct
modulation of various serotonin receptors8,9. Chronic therapy with early approved
antidepressants causes desensitization of 5-hydroxytryptamine (5-HT1A) on the presynaptic
neuron, thereby creating a negative feedback loop and possibly reducing their antidepressive
effects. Vortioxetine is an agonist of 5-HT1A on the presynaptic neuron, which can accelerate
the antidepressant effects, similar to pindolol, and incorporate serotonin transporter (SERT)
blockade10. This molecule acts as an antagonist, agonist, and partial agonist of multiple
serotonin receptors and is designed to help reduce depressive symptoms for treatment and
maintain response.
Vortioxetine has shown clinically significant results in Major Depressive Disorders (MDD),
and possible positive effects on the cognitive abilities of the participants were noted in a
few other studies with clinically significant improvement reported. An analysis by Baune et.
al showed that Vortioxetine was the only anti-depressant that improved cognitive abilities.
Many other studies have backed up this finding of Vortioxetine as an anti-depressant
improving the cognitive functions of patients with MDD when taken as directed.
To the best of the knowledge of Principal Investigators, there was no local study done to
assess the potential cognitive improvement seen with Vortioxetine when used as directed for
the treatment of Major Depressive Disorders.
Purpose of this study:
As such the purpose of this trial is to provide evidence to assess this claim in the
Pakistani population. This would be the first randomized trial dedicated for this assessment
in the region with active control of one of the most commonly used Selective Serotonin and
Norepinephrine Reuptake Inhibitors (SSNRIs) in Pakistan for the treatment of depression,
Venlafaxine.
