Major Depression with Digital Therapeutic for Adults

Digital Therapeutic as Adjunctive Therapy to Current Antidepressant

Study Specific Details:

This is a multi-center, randomized, controlled trial to evaluate the effectiveness of a digital therapeutic as adjunctive therapy in adults diagnosed with Major Depressive Disorder.
7 remote visits over 2 month study period.
Participant is reimbursed for their time and travel.

Male or Female ages 22-64.
Currently meets diagnosis of MDD as diagnosed by the M.I.N.I and score an 18 or higher on the HAM-D.
Treatment with the current ADT must be of adequate dose and duration of at least 6 weeks or longer and have less than a 50% reduction in depressive symptoms.
Must be willing to maintain ADT treatment at the current dose for the duration of the study.
Participants must be willing to download and use the digital mobile application.

A lifetime diagnosis of bipolar, schizophrenia, or schizoaffective disorder or other psychotic disorder.
Current PTSD, Panic or OCD as assessed by the M.I.N..I. or a diagnosis of any personality disorder.
Current GAD or Social Anxiety Disorder considered to be primary.
Current MDE lasting longer than 2 years.
Depression due to a general medical condition or neurological disorder.
Current diagnosis of substance or alcohol use disorder within 6 mo. of screening.
Currently receiving or have received psychotherapy within 3 months of screening. Patients who have failed to respond to an adequate course (8 weeks or longer) of CBT at any time in the past..
a suicidal ideation within the last 12 months prior to screening.
Medical history of seizures.
Patients who are considered resistant/refractory to treatment.
Patients who have received ketamine, esketamine, or arketamine for the treatment of depression. within the current major depressive episode.
Psychostimulants are not allowed.
Only one ADT from allowed list is permitted.

Want to learn more about Harmonex Neuroscience Research?