Major Depression Study for Adults

Icalcaprant vs Placebo for MDD

Icalcaprant vs Placebo – This is a double blind study in which subjects are randomly placed on either Icalcaprant or Placebo. Dr. Handal will be able to find out what medication the subject is on in case of an emergency.
This is a 6-week treatment period with the option of an open-label phase.
Participants are reimbursed $100 for their time and travel at the end of each completed visit.

Must be between the ages of 19-65
Moderate to severe depression.
Current major depressive episode must be at least 4 weeks prior to screening but not exceed 6 months.
BMI 18.0 to 35.0 kg/m
Psychotherapy for MDD is allowed if initiated at least 8 weeks prior to screening.
GLP-1 receptor agonist is allowed during the study, provided the same dose and dosing frequency have been unchanged for at least 3 months prior to baseline and will continue throughout the study.
No history of psychiatric hospitalization in the past 3 months prior to screening.
Generalized anxiety disorder, social anxiety, and/or panic disorder are allowed as long as major depression is the primary focus of treatment.

Has failed 3 or more antidepressants during the current depressive episode despite an adequate dose (per ATRQ) and duration (at least 6 weeks).
Has received treatment with TMS, esketamine, ketamine, electroconvulsive therapy, or vagus nerve stimulation within the past 12 months of screening.
Suicidal ideation within 6 months of screening.
Suicidal behavior within the last 12 months prior to screening.
Conditions that could interfere with the treatment absorption, including but not limited to bariatric surgery.
No history of ADHD, OCD, PTSD, personality disorder, anorexia, bulimia, binge eating disorder, or chronic fatigue syndrome in the past year prior to screening.
No history of any moderate or severe substance use disorder in the past 12 months prior to screening.
No lifetime history of schizophrenia, other psychotic disorders, mood episode with psychotic features, dissociative disorders, neurocognitive disorders, or opioid use disorder.
Stimulants, antidepressants, antipsychotics, mood stabilizers, anticonvulsants, Benzodiazepines/Sedatives hypnotics/Melatonin/Ramelteon, opioids w/in 2 weeks (4 weeks for fluoxetine) prior to randomization.
Has received hypnosis or acupuncture as a treatment for depressive symptoms in the past 4 weeks prior to screening.

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