Potcode Trial Essay

The DOTCODE trial included phase 1, the open antidepressant phase (week 0 to week 16), and phase 2, the add-on donepezil/placebo double-blind randomized phase (week 16 to week 78).

All patients continued to receive treatment for depression throughout phase 2. Patients on antidepressant medications at screening were eligible if a medication washout was clinically indicated, e.g., non-response to existing regimen or side effects. Antidepressant washout was per clinical judgment and ranged from immediate switch to 14 days. Patients previously on selective serotonin reuptake inhibitor (SSRI) citalopram were also eligible and the physician chose to treat them with citalopram or started them on Serotonin–norepinephrine reuptake inhibitor (SNRI)

Patients 55–60 years old may receive citalopram up to 40mg/day. After eight weeks, patients who did not respond to citalopram were switched to venlafaxine ER. Venlafaxine ER treatment began at 37.5 mg/day and was increased weekly, as tolerated and based on clinical response, to a maximum of 225 mg daily. Those who did not improve on venlafaxine ER (at least 25% improvement required in HRSD scores from baseline) at week 16 were switched to another antidepressant or an augmenting medication was added to their medication regiment when indicated. Antidepressant dosing was flexible based on the research physician’s assessment of the efficacy and tolerability of the medication. When response criteria (24-item HRSD ≤ 8 and the Clinical Global Impression depression score of much improved or better) were met, there were no further dose adjustments unless clinically indicated. Antidepressant treatment was discontinued when the patient was euthymic with 24-item HAM-D score ≤ 8 maintained during the