Phase 4 Depression and Anxiety Trial, Not Yet Recruiting NCT07393919 Sponsor: Universita di Verona Condition: Depression and Anxiety
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Phase 4 Depression and Anxiety Trial, Not Yet Recruiting

NCT07393919
Not Yet Recruiting Phase 4

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who are 18 years old or older.
  • People who have been diagnosed with a depressive disorder, either a single episode or a recurring condition (under the ICD-11 diagnostic codes 6A70 or 6A71).
  • People who are currently taking one of the following antidepressant medications for depression: an SSRI, an SNRI, a tricyclic antidepressant (TCA), or vortioxetine.
  • People who have been taking their current antidepressant for at least 6 months.
  • People whose current antidepressant dose has remained the same for the last 2 months.
  • People who score 9 or below on the PHQ-9 (a depression questionnaire) and 5 or below on the GAD-7 (an anxiety questionnaire) at the time of enrolling in the study.
  • People who do not currently meet the clinical criteria for an active depressive episode at the time of joining the trial.
  • People for whom the recruiting clinician finds no clear evidence of moderate-to-severe symptoms in the past 6 months.
  • People for whom the recruiting clinician has determined that stopping the antidepressant is clinically appropriate, and who have agreed to this through a shared decision-making process with their doctor.
  • People whose treating clinician is uncertain about which method of stopping the antidepressant would be best for that person.
  • People who are willing to sign a consent form agreeing to take part in the study.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have a formal diagnosis of a schizophrenia-spectrum disorder, bipolar disorder, or dementia, as diagnosed by a psychiatrist, neurologist, geriatrician, or relevant specialist.
  • People who are currently being treated with more than one antidepressant at full therapeutic doses.
  • People who are currently taking antidepressants from other classes, such as mirtazapine, agomelatine, or bupropion, either alone or alongside other antidepressants.
  • People who have a health condition or are taking a medication that makes it medically unsafe to use any of the antidepressants included in this trial — for example, people currently experiencing symptoms of mania (confirm with trial site).
  • People who are currently taking benzodiazepine medications at doses above the equivalent of 2.5 mg of lorazepam per day.
  • People who are pregnant or who plan to become pregnant.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Universita di Verona
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
30 September 2027

Primary endpoints

Proportion of Participants Who Do Not Successfully Discontinue Antidepressant Treatment Within 16 Weeks

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov