Table 3.
Psychopharmacological interventions
| Reference | Study Design | Depression Entry Criteria | M(SD) Baseline HbA1c levels | Enrolled/Completed | Antidepressant/Dosage/Duration | Depression Measures | Significant Depression Outcomes | Significant Health/Glucose Outcomes | Methodological Characteristics |
|---|---|---|---|---|---|---|---|---|---|
| SSRIs | |||||||||
| Lustman et al., 2000 | Double-blind RCT of fluoxetine or placebo | DIS MDD HDRS or BDI >= 14 | 8.4 (1.7)% fluoxetine group, 8.6 (1.6)% placebo group | 60/54 | Fluoxetine 20-40mg 8 weeks | BDI HDRS | Greater reduction in BDI (-14 v. –8.8, p=.03) and HDRS (-10.7 v. –5.2, p=.01) score in fluoxetine than placebo | HbA1c improved non-significantly (p=.13) more in fluoxetine (-.4%) than placebo (-.07%) | Double-blind placebo-controlled RCT with no follow-up interval, completer analyses, age 21-64, MDD inclusion criterion, type 1 or 2, HbA1c outcome measure |
| Lustman et al., 2006 | Double-blind RCT of sertraline or placebo | HDRS>=16 or BDI >=14 initially; BDI<=9 for 2 mos. | 8.2 (1.7)% | 152/130 | Sertraline 50-200mg 12 mos | BDI | Patients in sertraline group less likely to relapse (HR=.51, p=.01) | HbA1c level did not differ between groups | Double-blind placebo-controlled RCT with 1 year follow-up interval, completer analyses, age 18-80, type 1 or 2, MDD inclusion criterion, HbA1c outcome measure |
| Paile-Hyvarinen et al., 2003 | Single-blind RCT of paroxetine or placebo | MADRS 2.5-12 | 7.5 (.8)% in paroxetine group, 6.9 (.4)% placebo group | 15/13 | Paroxetine 20mg 10 weeks | MADRS BDI | No difference in BDI or MADRS between groups | HbA1c improved non-significantly (p=.08) more in paroxetine (-.44%) than placebo (-.07%) | Single-blind placebo-controlled RCT design with no follow-up interval, ITT analyses, post-menopausal women over 50, type 2, mild depressive symptoms, HbA1c outcome measure, |
| Paile-Hyvarinen et al., 2006 | Double-blind RCT of paroxetine or placebo | <= 6 sxs of MDD on interview | 8.5 (0.9)% paroxetine group, 8.7 (1.3)% placebo group | 49/37 | Paroxetine 20mg 6 months | HADS | No significant difference in HADS depression | At 3 mos, but not 6 mos, HbA1c was significantly (p=.018) lower in paroxetine group (7.9) than placebo (8.5) | Double-blind placebo-controlled RCT design with 6-month follow-up interval, completer analyses, age 50-70, type 2, mild depressive symptoms, HbA1c outcome measure |
| Amsterdam et al., 2006 | Open-label | SCID MDD, HDRS>=16 | Not reported | 17/14 | S-citalopram 10-20mg up to 16 weeks | HDRS | Significant reduction in HDRS score | Non-significant reduction in HbA1c | Open-label uncontrolled trial with no follow-up, pre-post completer analyses, age 18 or over, MDD diagnosis, type 1 or 2, HbA1c outcome measure |
| Gulseren et al., 2005 | Double-blind RCT of paroxetine or fluoxetine | SCID MDD, HDRS>=16 | 6.9 (1.2)% paroxetine group, 6.9 (1.7)% flouxetine group | 23/20 | Paroxetine, fluoxetine 20-40mg 12 weeks | HDRS | Both groups had significant reduction in HDRS score | Flouxetine group had non-significant reduction in HbA1c | Double-blind RCT design with no follow-up or control condition, pre-post completer analyses, MDD inclusion criterion, type 2, HbA1c outcome measure |
| Tri-cyclics | |||||||||
| Lustman et al., 1997 | Double-blind RCT of nortriptyline or placebo | DIS MDD | 11.8 (2.9)% nortiptyline group, 11.6 (3.1)% placebo group | 35/28 | Nortriptyline 50-150mg 8 weeks | BDI | Significantly greater (p=.03) reduction in nortriptyline group (-10.2) than placebo group (-5.8) | No difference in HbA1c | Double-blind placebo-controlled RCT with no follow-up interval, completer analyses, age 21-65, type 1 or 2, MDD criterion, HbA1c outcome measure |
| Other | |||||||||
| Lustman et al., 2007 | Open-label buproprion | DIS MDD | 8.3 (2.0)% | 93/75 | Buproprion 150-450mg 10 weeks | BDI | 84% depression remitted Reduction in depression severity predicted HbA1c | -.5% reduction in HbA1c levels | Open-label trial with no comparison group and 4-month follow-up interval, pre-post completer analyses, age 18-80, type 2, MDD criterion, HbA1c and other physiological outcome measures |