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:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT02971150
Eligibility Criteria:
* Inclusion Criteria:
* Age ≥ 60
* Diagnosis of Major Depressive Disorder (MDD)
* Diagnosis of Insomnia Disorder
* Must have failed ≥ 1 antidepressant trial
* Exclusion Criteria:
* Lifetime/current Bipolar I/II diagnosis
* Lifetime/current Schizophrenia Spectrum Disorder diagnosis
* Substance Use Disorder within past 3 months
* High Suicide Risk that cannot be safely managed
* Untreated Obstructive Sleep Apnea (OSA)
* Restless Legs Syndrome
* Rapid Eye Movement (REM) Sleep Behavior Disorder
* Active OR untreated Post Traumatic Stress Disorder (PTSD)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02971150
Study Brief:
Protocol Section:
NCT02971150