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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT05109195
Eligibility Criteria:
Inclusion Criteria:
* Has a diagnosis of Major Depressive Disorder (MDD) without psychotic features as confirmed by the Mini International Neuropsychiatric Interview (MINI)
* Treatment with an selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) for at least 6 weeks at an adequate dose (per Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire \[MGH-ATRQ\]). Specifically, one of the following in any formulation is allowed: SSRIs: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline; SNRIs: venlafaxine, desvenlafaxine, vilazodone, or vortioxetine
* In the opinion of the treating clinician, the participant requires augmentation of the current antidepressant treatment and plans to initiate augmentation treatment in the near future. The participant has agreed to receive augmentation treatment
* Is currently an outpatient receiving psychiatric care (not inpatient care settings)
* Has a body mass index (BMI) of 18-40 kilograms per meter square (Kg/m\^2), inclusive
Exclusion Criteria:
* Taking more than one antidepressant (regardless of class) at therapeutic doses (therapeutic doses per MGH-ATRQ). A second antidepressant is allowed to be taken at a lower dose if for sleep or pain management
* Is currently taking a benzodiazepine at higher doses than the equivalent of 3 milligrams (mg) of lorazepam
* Current diagnosis of a psychotic disorder including MDD with psychosis, bipolar disorder, intellectual disability, dementia, autism spectrum disorder, borderline personality disorder, or somatoform disorders
* Has treatment resistant depression (TRD) as defined by lack of response (less than \[\<\] 25 percent \[%\] improvement) of 2 or more antidepressants of adequate dose (per MGH-ATRQ) and duration (6 weeks) in this episode
* Current diagnosis of PTSD, obsessive compulsive disorder, fibromyalgia, anorexia nervosa, or bulimia nervosa. Participants may be enrolled if they have been in remission for the past year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT05109195
Study Brief:
Protocol Section:
NCT05109195