Phase 2 Depression and Anxiety Trial, Recruiting NCT07284667 Sponsor: ACADIA Pharmaceuticals Inc. Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT07284667
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:

  • Adults aged 18 to 65 years old
  • People who are willing and able to sign a consent form agreeing to take part
  • People who have been diagnosed with major depressive disorder (MDD)
  • People whose depression has not improved enough after trying at least two different antidepressant medications, with at least one of those unsuccessful attempts happening during their current episode of depression
  • People who are currently taking an approved antidepressant at a steady, unchanged dose before the screening appointment
  • People whose depression is rated as severe enough at both the screening and baseline appointments, based on three specific assessment tools used by the study team
  • Women who could become pregnant must have a negative pregnancy test and agree to use an accepted form of contraception during the trial; men must agree to use barrier contraception and not donate sperm during the trial

Who may not be able to join:

  • People who have a current diagnosis of certain personality disorders or long-term (persistent) depressive disorder
  • People with a recent history of substance use disorders, not including caffeine or nicotine
  • People who are currently considered to be at active risk of suicide, or who have recently attempted suicide
  • People with a history of schizophrenia, psychotic disorders, bipolar disorder, or depression with psychotic features
  • People who are currently receiving treatment for PTSD, acute stress disorder, panic disorder, or OCD
  • People with a history of two rare but serious medication reactions (neuroleptic malignant syndrome or serotonin syndrome), or a history of epilepsy (except for a single febrile seizure in infancy)
  • People whose depression has previously not responded to ketamine or esketamine treatment
  • People with a known allergy or sensitivity to ketamine or esketamine
  • People with significant heart or cardiovascular disease
  • People with a known history of hepatitis B, hepatitis C, or HIV infection
  • People with unstable diabetes or other poorly controlled medical conditions
  • People who test positive for illicit drugs or cannabis in a urine test
  • People who have received brain stimulation treatments — such as ECT, TMS, VNS, or DBS — during their current depressive episode
  • People who have recently started or made changes to their psychotherapy

Additional criteria not listed here may also apply, and the trial team will assess eligibility at the screening appointment.


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 14 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: +1(609) 250-6920

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
ACADIA Pharmaceuticals Inc.
Registry
ClinicalTrials.gov
Start date
14 November 2025
Est. completion
1 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 28

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: 14 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