Major Depression for Adults

Digital Therapeutic as Adjunctive Therapy to Current Antidepressant

Appointments can be done remotely or in office. 
 

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. 
  • Inclusion
  • Exclusion
  • 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. 
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