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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT02678702
Eligibility Criteria:
Inclusion Criteria
* Unipolar depression, either as a single episode or as periodic depression.
* HAM-D17 \> 18, i.e. moderate to severe depression.
* Time spent on falling asleep: more than 30 minutes at least three nights a week or
* Interrupted sleep with wake periods lasting more than 30 minutes at least three nights a week.
* Symptoms must have lasted for at least a month.
Exclusion Criteria:
* Other sleep disorder (e.g. moderat to severe Sleep apnoea and Periodic Limb Movements)
* Physical disorder that affects sleep to a considerable degree.
* Schizophrenia and bipolar disorder.
* Subject to other ongoing psychological treatment besides standard treatment.
* Suicidal to the equivalent of level 3 on HAM-D 17.
* Active substance abuse problem.
* Pregnancy.
* Shift work.
* Do not speak or understand danish
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
67 Years
Study:
NCT02678702
Study Brief:
Protocol Section:
NCT02678702