Major Depressive DisorderPhase 3VENUSNCT05104918
Vortioxetine as a Novel Anti-depressant With Improvement in Cognitive Abilities
A Phase 3 study testing Vortioxetine and Venlafaxine in people with Major Depressive Disorder, run by Scotmann Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Vortioxetine and Venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Diagnosis of recurrent MDD* > 3 months
- >26 score of MADRS
- Participant is a permanent resident of Rawalpindi/Islamabad so that follow up is easy
Who cannot join
- Age <18 or >65 years
- Presence of any other psychiatric disorders (other than MDD)
- Presence of any organic causes of depression like drug abuse, hypothyroidism, anemia, Cushing syndrome) (Attach reports**)
- Any physical, cognitive or language disability to perform the cognitive tests
- Risk of suicide
- Resistant to previous treatments with either of the interventions (Vortioxetine or Venlafaxine)
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- DSST score >70 at baseline visit
- According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) ** Lab tests:
- 1. Urine drug test for drug abuse 2. Serum TSH to exclude Hypothyroidism 3. Serum Hb to exclude Anaemia 4. Serum Cortisol to exclude Cushing syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Vortioxetine as a Novel Anti-depressant With Improvement in Cognitive Abilities - a Randomized Controlled Parallel Assigned Study
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.
Read the detailed 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine, Venlafaxine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called VORSCOT tablets
10 mg tablets
VenlafaxineDrug
Also called Venlafexine
75 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Vorscot Arm | Experimental | Vortioxetine 10 mg Receives: Drug: Vortioxetine |
| Vanlafexine Arm | Active comparator | Venlafaxine 75 mg Receives: Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression," and a total score of 60 or greater indicates "very severe depression."57 There is evidence that an improvement of two points or more on the MADRS is considered clinically relevant.
Measured: 8 weeks
Secondary outcomes (4)
Mini Mental State Examination (MMSE Score)
The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 25, the result is usually considered to be abnormal (indicating possible cognitive impairment)
Measured: 8 weeks
Montreal congnitive score
Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal. In the initial study data establishing the MoCA, normal controls had an average score of 27.4, compared with 22.1 in people with mild cognitive impairment (MCI) and 16.2 in people with Alzheimer's disease.
Measured: 8 weeks
Clinical Global Impression (CGI)
The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.[1] It is a brief 3-item observer-rated scale that can be used in clinical practice as well as in researches to track symptom changes.Its 3 items assess, 1) Severity of Illness (CGI-S), 2) Global Improvement (CGI-I), and 3) Efficacy Index (CGI-E, which is a measure of treatment effect and side effects specific to drugs that were administered.
Measured: 8 weeks
Digit symbol substitution test (DSST)
A score of 400 or higher for the majority of DSST tests is considered passing. The minimum is 200 and the maximum is 600. A score of 400 is comparable to earning a "C" grade on a test which would be considered passing. DSST tests are pass/fail and do not affect student's GPAs.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startFeb 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scotmann Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rawalpindi Medical College
- Responsible party
- Sponsor
- Investigators
- Muhammad Umar, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104918
- Sponsor's protocol ID
- VORSCOT
- Acronym
- VENUS
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vortioxetine as a Novel Anti-depressant With Improvement in Cognitive Abilities - a Randomized Controlled Parallel Assigned Study
- ClinicalTrials.gov ID
- NCT05104918
- Acronym / sponsor ID
- VENUS / VORSCOT
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Scotmann PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Rawalpindi Medical College
- Study start
- Feb 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vorscot Arm | Experimental | Drug: VortioxetineVortioxetine 10 mg |
| Vanlafexine Arm | Active comparator | Drug: VenlafaxineVenlafaxine 75 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Diagnosis of recurrent MDD* > 3 months
- >26 score of MADRS
- Participant is a permanent resident of Rawalpindi/Islamabad so that follow up is easy
Key exclusion criteria (9 listed)
- Age <18 or >65 years
- Presence of any other psychiatric disorders (other than MDD)
- Presence of any organic causes of depression like drug abuse, hypothyroidism, anemia, Cushing syndrome) (Attach reports**)
- Any physical, cognitive or language disability to perform the cognitive tests
- Risk of suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineAlso: VORSCOT tablets10 mg tablets | Drug | Vorscot Arm |
| VenlafaxineAlso: Venlafexine75 mg tablets | Drug | Vanlafexine Arm |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 8 weeks
The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression," and a total score of 60 or greater indicates "very severe depression."57 There is evidence that an improvement of two points or more on the MADRS is considered clinically relevant.
4 secondary outcomes
Mini Mental State Examination (MMSE Score)
Time frame: 8 weeks
Montreal congnitive score
Time frame: 8 weeks
Clinical Global Impression (CGI)
Time frame: 8 weeks
Digit symbol substitution test (DSST)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- DSST testLink provided by the sponsor.
- CGI testLink provided by the sponsor.
- Individual participant dataSharing planned: No. no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Umar principal investigator
Rawalpindi Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vortioxetine and Venlafaxine in people with Major Depressive Disorder, run by Scotmann Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmood ALi (00923105666079, lonsa25@student.london.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.