Major Depression Study – Adjunctive Therapy for Adults
$75 per completed visit
- Aticaprant vs Placebo – This is a double blind study in which subjects are randomly placed on either Aticaprant or Placebo as adjunctive treatment to their current antidepressant. Dr. Handal will be able to find out what medication the subject is on in case of emergency.
- This is a 6 week treatment period with option of open label phase.
- Participants are reimbursed $75 for their time and travel at the end of each completed visit.
- Must be between the ages of 19-74
- Participants 65 years of age or older must have had the first onset of depression prior to age 55
- Have had an inadequate response to at least 1 but no more than 3 antidepressants at an adequate dose (at or above the minimum therapeutic dose) and duration (at least 6 weeks) in current depressive episode. An inadequate response is defined as <50% reduction but with some improvement during the current antidepressant trial. There may be some minor or moderate symptomatic improvement since the initiation of treatment, but some of the initial symptoms are still present, troubling to the participant and affecting behavior and function.
- Must be currently taking and tolerating one of the following SSRIs or SNRIs: Celexa, Cymbalta, Lexapro, Luvox, Prozac, Milnacipran, Fetzima, Paxil, Zoloft, Effexor, Pristiq.
- The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression.
- BMI Between 18 and 40 kg
- Any of the following conditions have been the primary focus within the past 2 years: panic disorder, GAD, social anxiety, specific phobia
- The following conditions are allowed as secondary diagnosis to MDD along with being under control and stable for at lest 1 year: OCD, PTSD, anorexia nervosa, bulimia nervosa
- Current or history of: a psychotic disorder or MDD w/ psychotic features, bipolar or related disorders, intellectual disability, ASD, any type of personality disorder or somatoform disorder.
- History of moderate-to-severe substance use disorder within 6 months prior to screening.
- Has received any of the following in the past 5 years: ketamine/esketamine, electroconvulsive therapy (at least 7 treatments), vagal nerve stimulation, or deep brain stimulation device. Note: Participants who previously received up to 2 doses of ketamine/esketamine and did not continue, because they did not benefit or they experienced tolerability issues, can be considered for the study.
- Suicidal or homicidal within the past 3 months prior to screening.
- Cognitive impairment
- Seizures within the past 6 months
- Psychotherapy is allowed as long as it has been initiated for at least 6 weeks and duration and frequency are stable.
- Has been diagnosed with AIDS.
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