SUMMARY
- Given its potential to induce dissociative effects, carefully assess patients with psychosis before administering SPRAVATO; treatment should be initiated only if the benefit outweighs the risk.1
- SPRAVATO has not been formally studied in patients with schizophrenia or schizoaffective disorder.
- 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), borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder were excluded from the phase 3 treatment resistant depression trials.2-7
- A case report describes a 63-year-old patient with schizoaffective disorder who presented with catatonia and depressive symptoms and received SPRAVATO in combination with sublingual (SL) ketamine.8
- A case report describes a 28-year-old patient with treatment-resistant depression (TRD) with psychotic features who was treated with SPRAVATO over a period of three months.9
- No relevant articles were identified for the use of SPRAVATO in patients with comorbid schizophrenia.
Case Reports
Gregor et al (2023)8 presented a case report of a 63-year-old female who arrived at the emergency department with catatonia and depressive symptoms. She had a past medical history of bipolar I disorder, schizoaffective disorder, bipolar type, and TRD, with several prior psychiatric hospitalizations. She had not responded to several pharmacological agents and multiple rounds of ECT.
During the most recent admission, the patient was started on SL ketamine 50 mg twice a week along with diazepam. Upon symptom improvement, the patient was discharged home on SL ketamine, diazepam, methylphenidate ER, paliperidone, and sertraline. Progressive improvement was observed despite a slight setback when she missed a dose of ketamine. She was later prescribed SPRAVATO twice weekly in place of SL ketamine. After 1.5 months, she was maintained on 84 mg once weekly while also receiving supplemental doses of SL ketamine 150 mg weekly. The patient gradually resumed her baseline activities, remaining clinically stable, with no further acute hospitalizations in the months that followed.
Carter et al (2022)9 presented a case report of a 28-year-old African American female with TRD with psychotic features, which included auditory and visual hallucinations of self-harm and harming others. Her past medical history included generalized anxiety disorder and difficulty sleeping. After prior inadequate response to several antidepressants, antipsychotics, and mood stabilizers in combination with cognitive behavioral therapy (CBT), the patient was initiated on SPRAVATO along with other continued medications (bupropion 150 mg, aripiprazole 10 mg, trazodone 100 mg, clonazepam 0.5 mg, and sertraline 50 mg).
The patient was treated with SPRAVATO for a period of three months (14 treatment sessions) at an initiation dose of 56 mg which continued through induction and thereafter was increased to 84 mg. SPRAVATO was administered twice weekly for the first 8 sessions, weekly for the next 4 sessions, and then every two weeks. The Quick Inventory of Depressive Symptomology (QIDS) was used to evaluate the depressive symptoms at the beginning of each session. Pre-treatment QIDS score was 17 (severe depression), which reduced to 15 after 3 treatment sessions, and further decreased to 5 after 12 sessions. Nine months post treatment, the patient continued to be stable (QIDS, 8), with significantly reduced visualizations of self-harm and no auditory hallucinations. The patient reported less anhedonia, anxiety, and reduction in the number of times she had to miss work.
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT Drug databases (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 27 January 2026.
| 1 | Data on File. Company Core Data Sheet - Esketamine - Version 08. Janssen Research & Development, LLC; 2022. |
| 2 | Popova V, Daly EJ, Trivedi M. Supplement to: Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: a randomized double-blind active-controlled study. Am J Psychiatry. 2019;176(6):428-438. |
| 3 | Vazquez G, Gutierrez G, Rosenblat J, et al. Association of intranasal esketamine, a novel ‘standard of care’ treatment and outcomes in the management of patients with treatment-resistant depression: protocol of a prospective cohort observational study of naturalistic clinical practice. BMJ Open. 2022;12(9):e060967. |
| 4 | Ochs-Ross R, Daly EJ, Zhang Y, et al. Supplement to: Efficacy and safety of esketamine nasal spray plus an oral antidepressant in elderly patients with treatment-resistant depression - TRANSFORM-3. Am J Geriatr Psychiatry. 2020;28(2):121-141. |
| 5 | Wajs E, Aluisio L, Holder R, et al. Esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression: assessment of long-term safety in a phase 3, open-label study (SUSTAIN-2). J Clin Psychiatry. 2020;81(3):19m12891. |
| 6 | Janssen Research & Development, LLC. An open-label, long-term, safety and efficacy study of intranasal esketamine in treatment-resistant depression. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 April 12]. Available from: https://clinicaltrials.gov/ct2/show/NCT02497287. NLM Identifier: NCT02497287. |
| 7 | Daly EJ, Trivedi MH, Janik A, et al. Supplement to: Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2019;76(9):893-903. |
| 8 | Gregor EA, Zheng W. Oral and intranasal ketamine use in treatment-resistant catatonia: a clinical case report. Am J Case Rep. 2023;24(suppl 37095688):e939530. |
| 9 | Carter M, Solsrud K, Mischel N. Case report: intranasal esketamine for severe major depressive disorder with psychotic features. Front Psychiatry. 2022;13:937996. |