This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
SUMMARY
- The safety and efficacy of SPRAVATO have not been studied in patients with attention-deficit hyperactivity disorder (ADHD) and treatment-resistant depression (TRD) or major depressive disorder with active suicidal ideation and intent.
- Within the phase 3 clinical trial program for SPRAVATO1-8:
- Medications for ADHD were not permitted to be used for episodic use (as needed).
- ADHD medications could be continued but were not to be taken within 12 hours before or for 2 hours after a treatment session with SPRAVATO.
- Concomitant use with psychostimulants, such as amphetamines, methylphenidate, modafinil, and armodafinil, may increase blood pressure (BP); therefore, close monitoring of BP is recommended with concomitant use of SPRAVATO and psychostimulants.9
- Two real-world, retrospective studies reported the effectiveness and safety of SPRAVATO in patients with TRD in which patients also diagnosed with ADHD made up 25-30% of the population studied. Overall, mean depression scores improved over time; however, the studies did not provide a breakdown of results based on comorbidities.10,11
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 31 July 2024.
| 1 | Janssen Research & Development, LLC. A study to evaluate the efficacy, safety, and tolerability of fixed doses of intranasal esketamine plus an oral antidepressant in adult participants with treatment-resistant depression (TRANSFORM-1). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 31]. Available from: https://clinicaltrials.gov/study/NCT02417064 NLM Identifier: NCT02417064. |
| 2 | Janssen Research & Development, LLC. A study to evaluate the efficacy, safety, and tolerability of flexible doses of intranasal esketamine plus an oral antidepressant in adult participants with treatment-resistant depression (TRANSFORM-2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT02418585 NLM Identifier: NCT02418585. |
| 3 | Janssen Research & Development, LLC. A study to evaluate the efficacy, safety, and tolerability of intranasal esketamine plus an oral antidepressant in elderly participants with treatment-resistant depression (TRANSFORM-3). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 31]. Available from: https://clinicaltrials.gov/study/NCT02422186 NLM Identifier: NCT02422186. |
| 4 | Janssen Research & Development, LLC. A study of intranasal esketamine plus an oral antidepressant for relapse prevention in adult participants with treatment-resistant depression (SUSTAIN-1). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT02493868 NLM Identifier: NCT02493868. |
| 5 | Janssen Research & Development, LLC. A long-term, safety and efficacy study of intranasal esketamine in treatment-resistant depression (SUSTAIN-2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT02497287 NLM Identifier: NCT02497287. |
| 6 | Janssen Research & Development, LLC. A long-term safety study of esketamine nasal spray in treatment-resistant depression (SUSTAIN-3). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 31]. Available from: https://clinicaltrials.gov/study/NCT02782104 NLM Identifier: NCT02782104. |
| 7 | Janssen Research & Development, LLC. A study to evaluate the efficacy and safety of intranasal esketamine in addition to comprehensive standard of care for the rapid reduction of the symptoms of major depressive disorder, including suicidal ideation, in adult participants assessed to be at imminent risk for suicide (ASPIRE I). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT03039192. NLM Identifier: NCT03039192. |
| 8 | Janssen Research & Development, LLC. A study to evaluate the efficacy and safety of intranasal esketamine in addition to comprehensive standard of care for the rapid reduction of the symptoms of major depressive disorder, including suicidal ideation, in adult participants assessed to be at imminent risk for suicide (ASPIRE II). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 31]. Available from: https://clinicaltrials.gov/study/NCT03097133 NLM Identifier: NCT03097133. |
| 9 | Data on File. Esketamine. Core Company Data Sheet. Janssen Research & Development, LLC; 2024. |
| 10 | Brendle M, Ahuja S, Valle MD, et al. Safety and effectiveness of intranasal esketamine for treatment-resistant depression: a real-world retrospective study. J Comp Eff Res. 2022;11(18):1323-1336. |
| 11 | Marci CD, Karkare S, Jha MK, et al. Change in depressive symptoms following esketamine initiation among patients with treatment-resistant depression in a real-world setting. Poster presented at: Neuroscience Education Institute (NEI) Congress; November 9-10, 2023; Colorado Springs, CO. |
