Phase 2 Depression and Anxiety Trial, Recruiting NCT07226661 Sponsor: Supernus Pharmaceuticals, Inc. Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT07226661
Recruiting Phase 2

Who may 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 might be able to join this trial:

  • You have been diagnosed with Major Depressive Disorder (MDD) — either a single episode or a recurring one — without any psychotic features, confirmed through a structured interview with the study team.
  • Your current depressive episode has been ongoing for at least 8 weeks.
  • Your depression scores are at a moderate-to-severe level, measured at two separate visits before the trial begins (confirm with trial site for exact scoring details).
  • You have been taking one approved antidepressant medication at a stable, therapeutic dose for at least 8–10 weeks, and it has not improved your symptoms by 50% or more.

Who may not be able to join:

  • Your depression symptoms improved by 25% or more between your first and second screening visits.
  • You have already tried 3 or more antidepressant medications at adequate doses that did not work during your current depressive episode.
  • You have had an alcohol or substance use disorder within the past 6 months.
  • The study doctor believes you may be at significant risk of suicidal behavior during the trial.
  • You have ever been diagnosed with a psychotic disorder, bipolar disorder, schizophrenia, PTSD, autism spectrum disorder, a personality disorder, or an intellectual disability.
  • You were diagnosed with certain other mental health conditions (such as OCD, panic disorder, or eating disorders) within the past 12 months, or generalised anxiety disorder within the past 6 months, and those conditions have been the main focus of your treatment.
  • You have a significant history of heart, lung, digestive, kidney, liver, or blood disorders that the study doctor believes could put you at risk.
  • Your lab or test results before the trial showed clinically concerning abnormalities, including abnormal kidney function.
  • You need to take a medication or substance that is not permitted by the trial's rules.

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 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 301-838-2521

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Supernus Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
19 January 2026
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.

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: 22 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