Vortioxetine as a Novel Anti-depressant With Improvement in Cognitive Abilities

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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. As such the outcome of this trial will 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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scotmann Pharmaceuticals
• Collaborator: Rawalpindi Medical College
• Treatments: Venlafaxine Hydrochloride; Vortioxetine

Criteria

Inclusion Criteria:

1. Age 18-65 years

2. Diagnosis of recurrent MDD* > 3 months

3. >26 score of MADRS

4. Participant is a permanent resident of Rawalpindi/Islamabad so that follow up is easy

Exclusion Criteria:

1. Age <18 or >65 years

2. Presence of any other psychiatric disorders (other than MDD)

3. Presence of any organic causes of depression like drug abuse, hypothyroidism, anemia, Cushing syndrome) (Attach reports**)

4. Any physical, cognitive or language disability to perform the cognitive tests

5. Risk of suicide

6. Resistant to previous treatments with either of the interventions (Vortioxetine or Venlafaxine)

7. DSST score >70 at baseline visit