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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01601002
Eligibility Criteria:
Inclusion Criteria:
* patients older than 50 years
* meeting criteria for a diagnosis of major depressive disorder (DSM IV code 296.2x or 296.3x) as confirmed by a score \> 20 on the HAM-D 24 items scale and a structured clinical interview using the SCID by a consultant psychiatrist
Exclusion Criteria:
* Treatment resistant depression (as defined by failure to respond to ≥2 adequate antidepressant trials)
* Major depressive disorder with psychosis (296.x4)
* Those with depression who fulfill the chronic specifier (MDE for \>2 years)
* Significant Axis II pathology
* Previous trial with mirtazapine
* Concurrent antipsychotic usage
* Comorbid dementia (as confirmed by MMSE \< 24)
* Substance misuse including drug and/or alcohol dependence/abuse in the past 3 months
* Bipolar disorder
* Schizophrenia
* Obsessive compulsive disorder
* Post traumatic stress disorder
* Eating disorder
* Head injury
* Recent stroke (\< 3 months)
* Recent MI (\< 3 months)
* Currently actively participating in structured/formal psychotherapy
* Being non ambulatory
* Those actively suicidal
* Those incapable of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT01601002
Study Brief:
Protocol Section:
NCT01601002