"SAFE DISCONTINUATION OF ANTIDEPRESSANTS IN INDIVIDUALS WITH CLINICALLY REMITTED DEPRESSIVE DISORDERS"

简要总结

主要结局

次要结局

• Mean of DESS highest overall scores during the tapering phase and the 16-weeks follow-up period;
• Proportion of participants who fail to discontinue the AD by the end of the pre-defined schedule (with a tolerance period of no more than 15% of the total duration of the tapering phase)
• Proportion of participants who re-start an AD for any reason during the 16 weeks after its discontinuation. No pre-defined criteria for re-starting the AD will be employed. As occurs in realworld practice, the decision to re-start the AD can be taken by the recruiting psychiatrist, another practitioner not involved in the study, or independently by the participant;
• Proportion of participants failing to adhere to the pre-defined tapering schedule for any reason, including: new medical condition or treatment no longer compatible with the discontinuation strategy; new psychiatric condition or treatment no longer compatible with the discontinuation strategy; the participant discontinues the AD more quickly than the schedule; the participant resumes the previous AD dose and abandon the tapering schedule for reasons other than withdrawal symptoms or relapse.
• Proportion of participants experiencing “clinically relevant withdrawal symptoms” throughout the discontinuation and the 16-weeks follow-up period, defined as having at least one severe/extremely severe symptom or at least two moderately severe symptoms on the Discontinuation-Emergent Signs and Symptoms Scale (DESS) (Lewis et al., 2021), modified in order to assess the severity of each symptom as follows: 0=not present, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extremely severe;
• Proportion of participants experiencing clinical relapse throughout the discontinuation and the 16- weeks follow-up period, defined as having at least moderately severe depression or anxiety symptoms, namely a score ≥15 on the PHQ-9 or ≥10 on the GAD-7 (Kroenke et al., 2016);
• Proportion of participants leaving the study early due to any reason without meeting criteria for the primary outcome. This includes people who do not attend follow-up visits and cannot be contacted, people who refuse to be involved in follow-up assessments, or people who die during the tapering or the follow-up for reasons unrelated to withdrawal symptoms or relapse.
• Exploratory end point: Proportion of participants requiring one or more “rescue strategies” to address withdrawal symptoms during the tapering phase and the 16-weeks follow-up period;
• Exploratory end point: Time to clinical relapse (defined as having at least moderately severe depression or anxiety symptoms, namely a score ≥15 on the PHQ-9 or ≥10 on the GAD-7) at the end of the 16-weeks follow-up period;
• Exploratory end point: Time to clinical relapse (defined as having at least moderately severe depression or anxiety symptoms, namely a score ≥15 on the PHQ-9 or ≥10 on the GAD-7) at the end of the follow-up period (36 weeks from randomization);
• Exploratory end point: Proportion of participants experiencing “withdrawal-associated relapse”, defined as having a score ≥15 on the PHQ-9 or ≥10 on the GAD-7 within 4 weeks after the participant experienced “clinically relevant” withdrawal symptoms during the tapering phase and the 16-weeks follow-up period;
• Exploratory end point: PHQ-9 mean overall score at the end of 16-weeks follow-up period;
• Exploratory end point: GAD-7 mean overall score at the end of 16-weeks follow-up period;
• Exploratory end point: Proportion of participants with suicidal behaviours (including suicidal ideation, as reported by the participant, or according to a score ≥2 on the item 9 of the PHQ-9, suicide attempt, and deaths by suicide) at the end of 16-weeks follow-up period;
• Exploraotry end point: Short Form 12 Health Survey (SF-12) (Gandek et al., 1998) mean score on the Mental Component Summary at the end of the 16-weeks follow-up period;
• Exploratory end point: Social Adaptation Self-evaluation Scale (SASS) (Bosc et al., 1997) mean score at the end of the 16-weeks follow-up period;
• Exploratory end point: Cost-effectiveness, based on an adapted version of the Client Sociodemographic and Service Receipt Inventory (CSSRI-EU) (Chisholm et al., 2000);