NCT05104918

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_3 major-depressive-disorder

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

October 26, 2021

Last Update Submit

November 10, 2021

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (4)

  • Mini Mental State Examination (MMSE Score)

    8 weeks

  • Montreal congnitive score

    8 weeks

  • Clinical Global Impression (CGI)

    8 weeks

  • Digit symbol substitution test (DSST)

    8 weeks

Study Arms (2)

Vorscot Arm

EXPERIMENTAL

Vortioxetine 10 mg

Drug: Vortioxetine

Vanlafexine Arm

ACTIVE COMPARATOR

Venlafaxine 75 mg

Drug: Venlafaxine

Interventions

VortioxetineDRUG

10 mg tablets

Also known as: VORSCOT tablets
Vorscot Arm
VenlafaxineDRUG

75 mg tablets

Also known as: Venlafexine
Vanlafexine Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • DSST score \>70 at baseline visit
  • According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) \*\* Lab tests:
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

VortioxetineVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Muhammad Umar

    Rawalpindi Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmood ALi

CONTACT

00923105666079lonsa25@student.london.ac.uk

Muhammad Umar

CONTACT

051-9290755info@rmur.edu.pk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant would be randomly allocated to either of the two interventional groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 3, 2021

Study Start

February 1, 2022

Primary Completion

April 1, 2022

Study Completion

June 1, 2022

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

no plan