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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT03405493
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Depressive Episode (ICD10 F32) or Recurrent Depressive Disorder (F33).
* Minimum score of 8 or more on the Hamilton Depression Rating Scale (6 item) (Range 0-22) (Bech,1981).
* Age 18-65
* Able to give informed consent
* Women of child bearing age may be included and no methods of contraception is required to enable inclusion into the trial.
Exclusion Criteria:
* Current diagnosis of Seasonal Affective Disorder
* Current diagnosis of anorexia nervosa or bulimia.
* Current diagnosis of an obsessive compulsive or related disorder
* Current diagnosis of post-traumatic stress disorder
* History of schizophrenia, schizoaffective disorder or bipolar disorder
* Severe cognitive impairment, dementia, intellectual disability or organic brain disorder.
* History of stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence in past 3 months.
* Borderline Personality Disorder or other personality disorder considered to be the main problem.
* Duration of depression more than 2 years.
* Significant risk of suicide that requires hospitalisation.
* Severe eye disease or cataracts or traumatic injury or visual impairment affecting both eyes.
* History of epilepsy, uncontrolled severe headaches, or stroke as this may lower seizure threshold through sleep deprivation.
* Unstable medical condition that would make wake therapy intolerable
* Untreated sleep disorder such as obstructive sleep apnoea or narcolepsy
* Use of photo-sensitizing drugs.
* Current night-shift work.
* Non-English speaker.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03405493
Study Brief:
Protocol Section:
NCT03405493