Table 2.
Quality assessment criteria.
| Criteria numbers and names | Definition/Operationalization | |
|---|---|---|
| 1. | Validated analytical method for the determination of concentration in serum or plasma | Chromatography (all substances) or immunoassay (TCAs only) (4, 23). |
| 2. | Steady-state | Rated sufficient, if reported by authors. |
| 3. | Blood sampling and drug intake described | Rated sufficient, if reported by authors and sampling time of concentrations was given. |
| 4. | Patient selection | Classification system and diagnosis provided. |
| 5. | Measurement of illness severity and registration of therapeutic improvement or worsening: structured scale | Rated sufficient if severity assessments were performed using structured scales. |
| 6. | Baseline assessment of depression severity | Only if numerically reported, graphic display was not considered sufficient. |
| 7. | Adequate calculation of change | Percent improvement, predefined response-criterion, baseline-final score, Δ baseline-final score. |
| 8. | Sufficient time to rate effect | Minimum treatment duration: 2 weeks. |
| 9. | Comedication | Rated sufficient, if no comedication, which could influence pharmacokinetic or pharmacodynamic properties, is given, or if a sub-analysis is provided. Exception was constant somatic pre-treatment medication. |
| 10. | Placebo run-in | Placebo wash-out or run-in phase at the beginning of treatment. |
| 11. | Elimination of placebo responders | Elimination of placebo responders after predefined response criterion. |
| 12. | Dose design: fixed vs. flexible dose | Fixed dose design required for at least 2 weeks, exception: Titration in first 2 weeks of treatment. Otherwise rated insufficient. |
| 13. | Lower concentrations included to avoid ceiling effects (±10%) | Reported concentration means ± SD or range include lower part of therapeutic reference ranges (±10% of minimum concentration), graphic display not sufficient. |
| 14. | Adequate quantification of Side effects: structured scale or objective measurement | Rated sufficient, if a structured scale or objective measurement (e.g., Electrocardiogram, blood pressure, or pulse measurement) was used for assessment. |
Item 13 therapeutic reference ranges see Hiemke et al. (9).