Methods of monitoring adherence to lurasidone therapy
View Patent ↗The present disclosure provides methods for monitoring subject (e.g., patient) adherence to lurasidone therapy, for example as a component of treating a subject for a mental health disorder such as schizophrenia.
1. A method for identifying a subject as non-compliant with a prescribed lurasidone therapy, the method comprising:
obtaining a fluid sample from a subject who has been prescribed lurasidone therapy;
determining a level of M8/M9, M21, and/or M22 in the fluid sample; and
identifying the subject as adherent to the prescribed lurasidone therapy if the fluid sample contains M8/M9, M21, and/or M22 above a threshold level but non-adherent if the fluid sample contains no M8/M9, M21, and/or M22 or an amount of M8/M9, M21, and/or M22 below a threshold level,
wherein the fluid sample is a urine sample, and
wherein the step of determining the level of the M8/M9, M21, and/or M22 in the fluid sample comprises mass spectrometry.
2. The method of claim 1 further comprising counseling the subject on dangers of non-adherence to lurasidone therapy if the subject is identified as non-adherent.
3. The method of claim 1 , wherein the threshold level is a minimum detectable amount of M8/M9, M21, and/or M22.
4. The method of claim 1 , wherein the threshold level is about 50 ng/mL.
5. The method of claim 1 , wherein the threshold level is about 5 ng/mL.
6. A method for identifying a subject as non-compliant with a prescribed lurasidone therapy, the method comprising:
obtaining a fluid sample from a subject who has been prescribed lurasidone therapy;
determining a level of at least two of M8/M9, M21, and M22 in the fluid sample; and
identifying the subject as adherent to the prescribed lurasidone therapy if the fluid sample contains the at least two of M8/M9, M21, and M22 above a threshold level but non-adherent if the fluid sample contains no amount of the at least two of M8/M9, M21, and M22 or an amount of the at least two of M8/M9, M21, and M22 below a threshold level,
wherein the fluid sample is a urine sample, and
wherein the step of determining the level of the at least two of M8/M9, M21, and M22 in the fluid sample comprises mass spectrometry.
7. The method of claim 6 , wherein the threshold level is a minimum detectable amount of M8/M9, M21, and/or M22.
8. The method of claim 6 , wherein the threshold level is about 50 ng/mL.
9. The method of claim 6 , wherein the threshold level is about 5 ng/mL.
10. The method of claim 6 , wherein the at least two of M8/M9, M21, and M22 comprises M8/M9 and M21.
11. The method of claim 6 , wherein the at least two of M8/M9, M21, and M22 comprises M8/M9 and M22.
12. The method of claim 6 , wherein the at least two of M8/M9, M21, and M22 comprises M21 and M22.
13. The method of claim 6 , wherein the at least two of M8/M9, M21, and M22 comprises M8/M9, M21 and M22.
14. A method for identifying a subject as non-compliant with a prescribed lurasidone therapy, the method comprising:
obtaining a fluid sample from a subject who has been prescribed lurasidone therapy;
determining a level of M8/M9, M21, and M22 in the fluid sample; and
identifying the subject as adherent to the prescribed lurasidone therapy if the fluid sample contains M8/M9, M21, and M22 above a threshold level but non-adherent if the fluid sample contains no amount of M8/M9, M21, or M22 or an amount of M8/M9, M21, and M22 below a threshold level,
wherein the fluid sample is a urine sample, and
wherein the step of determining the level of M8/M9, M21, and M22 in the fluid sample comprises mass spectrometry.
15. The method of claim 14 , wherein the threshold level is a minimum detectable amount of M8/M9, M21, and/or M22.
16. The method of claim 14 , wherein the threshold level is about 50 ng/mL.
17. The method of claim 14 , wherein the threshold level is about 5 ng/mL.