Esketamine nasal spray: New hope for resistant depression

On March 05, 2019 The U.S. Food and Drug Administration approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepresant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).

Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).

Non respondents depressives:

Patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have treatment-resistant depression.

Spravato!

The Spravato labeling contains a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.

Because of the risk of sedation and dissociation, patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose.

The REMS requires the prescriber and the patient to both sign a Patient Enrollment Form that clearly states that the patient understands they should make arrangements to safely leave the health care setting to get home and that the patient should not drive or use heavy machinery for the rest of the day on which they received the drug.

Additionally, Spravato must be dispensed with a patient Medication Guide that outlines the drug’s uses and risks.

Day case Psychiatric Protocol for Spravato treatment use :

Here’s a day case psychiatric protocol for the use of Spravato (esketamine nasal spray) in a clinical setting. This protocol is designed for patients with treatment-resistant depression who have been approved for Spravato treatment.

Spravato Day Case Protocol:

1. Pre-Treatment Assessment:
   • Confirm diagnosis of treatment-resistant depression
   • Review medical history, current medications, and contraindications
   • Assess cardiovascular risk factors
   • Obtain informed consent
   • Ensure patient has arranged for transportation home
2. Day of Treatment: a. Initial Assessment:
   • Verify patient identity and confirm fasting status (no food for 2 hours, no liquids for 30 minutes)
3. • Check vital signs (blood pressure, heart rate, respiratory rate)
4. • Assess current mood and suicidal ideation Perform brief cognitive assessment
5. • Confirm absence of substance use in the past 24 hours
   b. Pre-Administration:
   • Ensure treatment room is quiet and comfortable
6. • Have patient empty bladder
7. • Provide patient with emesis basin if needed
   c. Spravato Administration:
8. • Instruct patient on proper nasal spray technique
9. • Administer prescribed dose (56 mg or 84 mg)
10. • Record time of administration
    d. Post-Administration Monitoring:
    • Monitor blood pressure at 40 minutes, 1 hour, and 1.5 hours post-dose
11. • Continuously observe patient for adverse effects
12. • Assess for dissociation and sedation using standardized scales (e.g., CADSS, MOAA/S)
13. • Provide supportive care as needed
    e. Recovery Period:
    • Minimum 2-hour observation period post-administration
14. • Offer light snacks and water when appropriate
15. • Reassess mood and cognitive function before discharge
    f. Discharge Criteria:
    • Stable vital signs MOAA/S score of 5 (fully alert and oriented)
16. • No significant adverse effects
17. • Patient feels safe to leave and has arranged transportation
    g. Discharge Instructions:
    • Provide written and verbal instructions on post-treatment care
    • Advise against driving, operating machinery, or making important decisions for the rest of the day
    • Instruct on when to seek medical attention
    • Schedule next treatment session
18. Follow-up:
    • Telephone follow-up within 24-48 hours
    • Schedule next treatment session (typically twice weekly for 4 weeks, then weekly)
19. Documentation:
    • Complete treatment administration record
    • Document vital signs, adverse effects, and patient response
    • Update treatment plan based on response
20. Emergency Preparedness:
    • Ensure crash cart and emergency medications are readily available
    • Have protocols in place for managing severe hypertension or other adverse events
21. Staff Requirements:
    • Trained healthcare provider to administer and monitor treatment
    • Mental health professional available for psychological support if needed

This protocol provides a framework for Spravato administration in a day case setting.

It’s crucial to adapt this protocol to your specific clinical setting and to follow all regulatory guidelines and manufacturer recommendations for Spravato use.