Comparing Algorithm Guided Treatment to Usual Care for Adults with Treatment Resistant Depression Aged 18 to 65

What this Trial Is About

Researchers are evaluating treatment strategies for adults aged 18 to 65 with treatment resistant depression who have not achieved stable remission in the past year. This study compares an algorithm guided treatment AGT approach with usual clinical care treatment as usual, TAU to see if AGT leads to greater improvement in depressive symptoms over 12 weeks. The study also aims to assess cognitive and psychosocial functioning, suicide risk, treatment adherence, and long-term outcomes at 24 weeks. Participants are randomly assigned to either the AGT or TAU group. The AGT group follows a structured treatment plan with predefined steps and decision points based on symptom response, prior treatment history, and tolerability. Treatment adjustments are guided by specific if-then rules after outpatient visits at weeks 4, 8, and 12. The TAU group receives standard care determined by experienced senior consultants. After the initial 12-week treatment phase, there is a 12-week follow-up period where all participants continue treatment as decided by their clinicians. Throughout the study, participants attend visits at baseline, 4, 8, 12, and 24 weeks. At these visits, depression severity is measured using the 6-item Hamilton Depression Rating Scale HAMD-6, along with assessments of cognitive function, psychosocial status, suicide risk, treatment adherence, and medication changes. Safety and tolerability are monitored, and longer-term outcomes are evaluated during the follow-up. The total participation time is 24 weeks, allowing researchers to observe both short- and longer-term effects of the treatments.

Algorithm Guided Treatment Versus Treatment as Usual (TAU) for Patients With Treatment Resistant Depression