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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT02085135
Eligibility Criteria:
Inclusion Criteria:
* Body mass index of 18-40 kg/m2
* Have a diagnosis of MDD
* Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
* Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
* Have an inadequate response to current antidepressant treatment
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply
Exclusion Criteria:
* Currently pregnant or breastfeeding
* History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
* Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
* Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
* Have received electroconvulsive therapy treatment within the last 5 years
* Have attempted suicide within the past 2 years
* Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Have had a significant blood loss or blood donation with 60 days of screening
* Additional criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02085135
Study Brief:
Protocol Section:
NCT02085135