New study tests best method to quit antidepressants without relapse
NCT ID NCT07393919
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two strategies for safely stopping antidepressants in adults whose depression is in remission. Participants will be randomly assigned to either a standard gradual dose reduction or a more precise hyperbolic tapering method. The goal is to see which approach leads to more successful discontinuation with fewer withdrawal symptoms or relapse over 36 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years old or above; * 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; * 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. Exclusion Criteria: * 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; * current treatment with ADs of other classes (e.g., mirtazapine, agomelatine, bupropion, for which the evidence on the risk of withdrawal is unclear), 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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