Abstract
Duloxetine (DLX) is a dual serotonin and norepinephrine reuptake inhibitor that has been recently approved for the treatment of major depressive disorder (MDD). However, little is known about the relationship between DLX plasma levels and clinical response. The aims of this open-label study were 1) to assess clinical outcome and tolerability of DLX by means of clinician and patient assessments and 2) to evaluate the value of plasma DLX levels as predictors of clinical response and tolerability. This was a naturalistic, open-label study of 45 outpatients affected with MDD (16 men and 29 women), who received DLX at doses of 30-120 mg/day and were evaluated at baseline (T0) and after 2, 4 and 12 weeks (T1-3). The assessments included the Hamilton Rating Scales for Depression (HRSD) and Anxiety (HRSA), Clinical Global Impression-Severity (CGI-S), Beckgs Depression Inventory (BDI) and a mood visual analogue scale (VAS). Compared with T0, there were significant improvements in HRSD at T1, T2 and T3 (P <0.001), in HRSA, CGI-S and the self-administered BDI at T2 and T3 (P <0.001), and in the VAS scores shown at T3 (P = 0.01). DLX treatment was safe and well tolerated. Plasma DLX levels at T2 ranged from 5 to 135 ng/mL (mean ± SD = 53.56 ± 39.45) and correlated almost significantly with the DLX dose (r = 0.35; P = 0.069). There was a significant curvilinear quadratic relationship between the improvement of HRSA scores and plasma DLX levels (R 2 = 0.27; P = 0.02). The incidence of anxiety or irritability was associated with the highest plasma levels. Our findings suggest that monitoring plasma DLX levels may be helpful in predicting better treatment responses and tolerability. The present data seem to suggest an optimal anxiolytic efficacy of DLX at intermediate plasma levels.
| Original language | English |
|---|---|
| Pages (from-to) | 1193-1199 |
| Number of pages | 7 |
| Journal | Journal of Psychopharmacology |
| Volume | 24 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 2010 |
Fingerprint
Keywords
- clinical response
- duloxetine
- major depressive disorder
- plasma levels
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
- Psychiatry and Mental health
Cite this
Clinical outcome and tolerability of duloxetine in the treatment of major depressive disorder : A 12-week study with plasma levels. / Volonteri, L. S.; Colasanti, A.; Cerveri, G.; Fiorentini, A.; De Gaspari, I. F.; Mauri, M. C.; Valli, A.; Papa, P.; Mencacci, C.
In: Journal of Psychopharmacology, Vol. 24, No. 8, 08.2010, p. 1193-1199.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Clinical outcome and tolerability of duloxetine in the treatment of major depressive disorder
T2 - A 12-week study with plasma levels
AU - Volonteri, L. S.
AU - Colasanti, A.
AU - Cerveri, G.
AU - Fiorentini, A.
AU - De Gaspari, I. F.
AU - Mauri, M. C.
AU - Valli, A.
AU - Papa, P.
AU - Mencacci, C.
PY - 2010/8
Y1 - 2010/8
N2 - Duloxetine (DLX) is a dual serotonin and norepinephrine reuptake inhibitor that has been recently approved for the treatment of major depressive disorder (MDD). However, little is known about the relationship between DLX plasma levels and clinical response. The aims of this open-label study were 1) to assess clinical outcome and tolerability of DLX by means of clinician and patient assessments and 2) to evaluate the value of plasma DLX levels as predictors of clinical response and tolerability. This was a naturalistic, open-label study of 45 outpatients affected with MDD (16 men and 29 women), who received DLX at doses of 30-120 mg/day and were evaluated at baseline (T0) and after 2, 4 and 12 weeks (T1-3). The assessments included the Hamilton Rating Scales for Depression (HRSD) and Anxiety (HRSA), Clinical Global Impression-Severity (CGI-S), Beckgs Depression Inventory (BDI) and a mood visual analogue scale (VAS). Compared with T0, there were significant improvements in HRSD at T1, T2 and T3 (P <0.001), in HRSA, CGI-S and the self-administered BDI at T2 and T3 (P <0.001), and in the VAS scores shown at T3 (P = 0.01). DLX treatment was safe and well tolerated. Plasma DLX levels at T2 ranged from 5 to 135 ng/mL (mean ± SD = 53.56 ± 39.45) and correlated almost significantly with the DLX dose (r = 0.35; P = 0.069). There was a significant curvilinear quadratic relationship between the improvement of HRSA scores and plasma DLX levels (R 2 = 0.27; P = 0.02). The incidence of anxiety or irritability was associated with the highest plasma levels. Our findings suggest that monitoring plasma DLX levels may be helpful in predicting better treatment responses and tolerability. The present data seem to suggest an optimal anxiolytic efficacy of DLX at intermediate plasma levels.
AB - Duloxetine (DLX) is a dual serotonin and norepinephrine reuptake inhibitor that has been recently approved for the treatment of major depressive disorder (MDD). However, little is known about the relationship between DLX plasma levels and clinical response. The aims of this open-label study were 1) to assess clinical outcome and tolerability of DLX by means of clinician and patient assessments and 2) to evaluate the value of plasma DLX levels as predictors of clinical response and tolerability. This was a naturalistic, open-label study of 45 outpatients affected with MDD (16 men and 29 women), who received DLX at doses of 30-120 mg/day and were evaluated at baseline (T0) and after 2, 4 and 12 weeks (T1-3). The assessments included the Hamilton Rating Scales for Depression (HRSD) and Anxiety (HRSA), Clinical Global Impression-Severity (CGI-S), Beckgs Depression Inventory (BDI) and a mood visual analogue scale (VAS). Compared with T0, there were significant improvements in HRSD at T1, T2 and T3 (P <0.001), in HRSA, CGI-S and the self-administered BDI at T2 and T3 (P <0.001), and in the VAS scores shown at T3 (P = 0.01). DLX treatment was safe and well tolerated. Plasma DLX levels at T2 ranged from 5 to 135 ng/mL (mean ± SD = 53.56 ± 39.45) and correlated almost significantly with the DLX dose (r = 0.35; P = 0.069). There was a significant curvilinear quadratic relationship between the improvement of HRSA scores and plasma DLX levels (R 2 = 0.27; P = 0.02). The incidence of anxiety or irritability was associated with the highest plasma levels. Our findings suggest that monitoring plasma DLX levels may be helpful in predicting better treatment responses and tolerability. The present data seem to suggest an optimal anxiolytic efficacy of DLX at intermediate plasma levels.
KW - clinical response
KW - duloxetine
KW - major depressive disorder
KW - plasma levels
UR - http://www.scopus.com/inward/record.url?scp=77955164450&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77955164450&partnerID=8YFLogxK
U2 - 10.1177/0269881109104863
DO - 10.1177/0269881109104863
M3 - Article
C2 - 19406851
AN - SCOPUS:77955164450
VL - 24
SP - 1193
EP - 1199
JO - Journal of Psychopharmacology
JF - Journal of Psychopharmacology
SN - 0269-8811
IS - 8
ER -