Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT05104918
Eligibility 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05104918
Study Brief:
Protocol Section:
NCT05104918