Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

Table 2 Algorithm for the sertraline treatment in the DAD trial

	No improvement (< 20%)			At least minimal improvement
	(CGI = 0)			(CGI 1 to 3)
UKU side effects	50 mg	75-175 mg	200 mg	50 mg	75-175 mg	200 mg
Absent (0) mild (1)	⇔ or ⇧	⇔ or ⇧	⇔ or x	⇔ or ⇧	⇔ or ⇧	⇔
Moderate (2) severe (3)	x	⇩	⇩	x	⇩	⇩

Note: Moderate/severe side effects are side effects that impairs the patient ⇧ Increase dose in 25-50 mg/day steps, ⇩ reduce dose in 25-100 mg/day steps, ⇔ wait and see without change in dose (generally up to 4–6 weeks), x = consult psychiatric hotline and decide how to procede afterwards or discontinue the medication without further consultation. The decisions should always be based on the tolerability as assessed by the treating physician with the UKU, the treatment response assessed by the physician using the CGI rating, and treatment effects and tolerability as judged by the patient. In the end, the decision has to be made by the treating physician based on the algorithm recommendations and the judgement of the patients.

ISSN: 1471-244X