SUMMARY  

• In phase 3 trials in TRD, the following were excluded: participants with a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders (confirmed by the MINI), comorbid obsessive-compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder¹, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality   disorder.^1-6
• SPRAVATO has not been formally evaluated in patients with TRD and Anxiety Disorders (i.e. Generalized Anxiety Disorder, Panic Attacks, Agoraphobia, Social Anxiety Disorder), or Post-Traumatic Stress Disorder (PTSD); however, results of the Mini-International Neuropsychiatric Interview (MINI), used to identify the presence of comorbid psychiatric conditions, are found in the Table: MINI Results - Pooled (TRANSFORM-1, TRANSFORM-2, and SUSTAIN-1) and TRANSFORM-3.

Results of the MINI

The MINI (Mini-International Neuropsychiatric Interview - Mental Status Questionnaire) is a short, structured psychiatric interview used to confirm the diagnosis of major depressive disorder and other present psychiatric conditions. This diagnostic interview was conducted at the site at the first screening visit to confirm patient eligibility.

The pooled incidence of common psychiatric comorbidities upon enrollment in the phase 3 TRD trials in adults 18-64 (TRANSFORM-1, TRANSFORM-2, and SUSTAIN-1) and separately in adults ≥65 (TRANSFORM-3) can be found in the Table: MINI Results - Pooled (TRANSFORM-1, TRANSFORM-2, and SUSTAIN-1) and TRANSFORM-3.⁷

Literature search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 16 December 2024.