Trazodone with Extended Release Improves Patient Compliance

Post-registration Study

From July 2015 to November 2016, a post-registration, non-interventional, observational, prospective multicenter study was conducted in 8 psychiatric centers in the Czech Republic. Its goal was to evaluate the efficacy, tolerability, and safety of trazodone in its new formulation (Trittico Prolong^® 300 mg) in patients diagnosed with moderate to severe depression of various etiologies under routine clinical practice conditions.

Population Studied

A total of 85 patients were included in the study, who scored > 21 on the MADRS (Montgomery-Åsberg Depression Rating Scale) and a score of ≥ 4 on the CGI/S (Clinical Global Impression - Severity) depression severity scale. Many of the enrolled patients had undergone previous antidepressant treatment, half were using anxiolytics and hypnotics, and some were being treated with other psychopharmaceuticals.

Methodology and Course

The acute phase of trazodone treatment lasted for 5 weeks. During the 1st week, titration took place, and the following 4 weeks, patients received full doses. 80 patients completed the treatment. Efficacy was assessed by changes in MADRS and CGI/S scores in the 1st and 5th weeks, and clinical improvement was assessed using the CGI - Improvement (CGI/I) score in the 5th week. The onset of effect was also monitored. Safety and tolerability of trazodone were determined based on the occurrence and intensity of side effects (SE) in the 1st and 5th weeks, including the frequency of treatment discontinuation due to SE. A month after the active phase (9th week) and after 3 more months (21st week), patients were invited for follow-up.

Results

After the 1st week of treatment (end of titration), there was a significant reduction in the total MADRS score from the initial average value of 27.4−21.2 (p < 0.001). In the 5th week, there was a further decrease to 7.9 (p < 0.001). The severity of depression according to CGI/S also declined. At the end of acute treatment, 88% (71 out of 80) of patients had their depression completely resolved or persisted at a very mild to moderate level (CGI/S ≤ 3). According to CGI/I, 93.8% (75 out of 80) of patients showed very significant, significant, or mild improvement (CGI/I 1−3). 37.6% (32 out of 85) patients reported feeling improvement after just 6 days of treatment.

Side effects occurred in the 1st week in 50.6% (43 out of 85) of patients in the form of fatigue (27.1%; 23 out of 85) and somnolence (22.4%; 19 out of 85), and were markedly transient. After another 4 weeks, the occurrence of side effects decreased by almost 75% (10 out of 80, p < 0.001). Fatigue occurred in 7.5% (6 out of 80) patients, and somnolence in only 5% (4 out of 80).

After another 4 weeks (9th week), 78.8% (63 out of 80) patients showed up for follow-up. In 71.4% (45 out of 63), the mental state was evaluated as unchanged, in 28.6% (18 out of 63) as improved. After another 3 months (21st week), 71.3% (57 out of 80) of patients attended. In 80.7% (46 out of 57), there was no change, in 19.3% (11 out of 57), there was improvement. No deterioration was observed in any patient. Concurrent use of anxiolytics and hypnotics also decreased. Tolerance of the treatment was rated in the 9th week as excellent in 88.9% (56 out of 63) and good in 11.1% (7 out of 63) of patients, in the 21st week as excellent in 94.7% (54 out of 57) and good in 5.3% (3 out of 57) of patients. No case of poor tolerability was identified.

Conclusion

Trazodone in its new formulation demonstrated very good effects both in cases of previously untreated depressive episodes and in cases that did not respond to previous antidepressant therapy.

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Source: Češková E., Šedová M., Kellnerová R., Starobová O. Once-a-day trazodone in the treatment of depression in routine clinical practice. Pharmacology 2018; 102: 206–212, doi: 10.1159/000492079.