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"SAFE DISCONTINUATION OF ANTIDEPRESSANTS IN INDIVIDUALS WITH CLINICALLY REMITTED DEPRESSIVE DISORDERS"
EU CTIS ID: 2023-509377-23-00
What this study is testing
The DISCARD study will compare hyperbolic with linear tapering in adults with currently remitted depression. The primary outcome will be the 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) or re-initiate the AD during the 16 weeks after its discontinuation.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years old or above;
- uncertainty about which discontinuation strategy would be best for the participant;
- the participant is willing to sign the informed consent to participate to the study.
- diagnosed with a depressive disorder, single episode (ICD-11, 6A70) or recurrent (ICD-11, 6A71);
- currently taking a selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA), or vortioxetine for the treatment of depression;
- the current AD has been taken for at least 6 months;
You likely can't join if
- comorbid schizophrenia-spectrum disorders, bipolar disorder, or dementia, as formally diagnosed by a psychiatrist, neurologist, geriatrician, or other specialists;
- current treatment with more than one AD at therapeutic doses;
- ccurrent treatment with ADs of other classes (e.g., mirtazapine, agomelatine, bupropion, for which the evidence on the risk of withdrawal is unclear) (Taylor, 2021), alone or in combination with other ADs;
- conditions or medications that contraindicate the use of any AD according to the Summary of Product Characteristics of included ADs (synthetically reported in Table 1) (e.g., current symptoms of mania);
- current treatment with benzodiazepines above the dose of 2.5 mg equivalents of lorazepam per day (corresponding to clonazepam 1.2 mg/day; alprazolam 1.2 mg/day; diazepam 19 mg/day);
- pregnancy or willingness to become pregnant.
See the full eligibility criteria
- 18 years old or above;
- uncertainty about which discontinuation strategy would be best for the participant;
- the participant is willing to sign the informed consent to participate to the study.
- diagnosed with a depressive disorder, single episode (ICD-11, 6A70) or recurrent (ICD-11, 6A71);
- currently taking a selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA), or vortioxetine for the treatment of depression;
- the current AD has been taken for at least 6 months;
- the current AD has been on a stable dose over the last 2 months;
- a score ≤9 on the PHQ-9 and ≤5 on the GAD-7 at study enrolment;
- DSM-5-TR criteria for a depressive episode are not met at the time of recruitment;
- no clinical evidence of moderate-to-severe symptoms in the last 6 months, as assessed by the recruiting clinician;
- discontinuing the AD is clinically indicated by the recruiting clinician, and agreed to by the participant in a shared decision-making process;
- comorbid schizophrenia-spectrum disorders, bipolar disorder, or dementia, as formally diagnosed by a psychiatrist, neurologist, geriatrician, or other specialists;
- current treatment with more than one AD at therapeutic doses;
- ccurrent treatment with ADs of other classes (e.g., mirtazapine, agomelatine, bupropion, for which the evidence on the risk of withdrawal is unclear) (Taylor, 2021), alone or in combination with other ADs;
- conditions or medications that contraindicate the use of any AD according to the Summary of Product Characteristics of included ADs (synthetically reported in Table 1) (e.g., current symptoms of mania);
- current treatment with benzodiazepines above the dose of 2.5 mg equivalents of lorazepam per day (corresponding to clonazepam 1.2 mg/day; alprazolam 1.2 mg/day; diazepam 19 mg/day);
- pregnancy or willingness to become pregnant.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.