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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT03429361
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female aged 18 to 65 years (inclusive) at time of informed consent
* Diagnosis of Major Depression Disorder (MDD) or Bipolar Disorder (BD) as assessed using the Structured Clinical Interview for DSM Disorders-Clinical Trials (SCID-CT)
* Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 26; Patient Health Questionnaire (PHQ-9) ≥ 15; Clinical Global Impression (CGI) ≥ 4 at screening
* Ownership of a personal smartphone and willingness to install and maintain the Mindstrong app for digital assessments throughout participation in the study
* Able to understand and comply with instructions in English
* Has a significant other who accompanies participant to treatment appointments and agrees to complete assessments
* Undergoing ketamine treatment at the Kadima Clinic, or determined by the Kadima Clinic to be eligible for ketamine treatment and agrees to receive such treatment prior to being asked to participate in this research
Exclusion Criteria:
* Female who is currently pregnant or planning a pregnancy within 6 months
* Has any other current Axis I DSM-5 disorder other than MDD or BD, which is the primary focus of treatment
* Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
* Has a visual or physical motor impairment that could interfere with study tasks
* Is site personnel directly affiliated with this study
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03429361
Study Brief:
Protocol Section:
NCT03429361