Phase 3 Depression and Anxiety Trial, Recruiting NCT06752759 Sponsor: Theresa Jacob, PhD, MPH Condition: Depression and Anxiety
Back to Depression And Anxiety

Phase 3 Depression and Anxiety Trial, Recruiting

NCT06752759
Recruiting Phase 3

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 years and older who score 20 or higher on a standard depression rating scale (called the MADRS), which measures the severity of depression symptoms
  • People with a diagnosis of moderate to severe Major Depressive Disorder (MDD)
  • People whose MDD diagnosis has been confirmed through a structured clinical interview based on standard psychiatric guidelines (called the SCID-5)

Who may not be able to join:

  • People who have a known allergy to Ketamine
  • People who have a known allergy to Midazolam
  • People with a history of mania or hypomania, or a diagnosis of bipolar disorder
  • People currently taking lithium and/or lamotrigine (medications often used in mood disorders)
  • People currently experiencing thoughts of harming others with an intention to act on them
  • People whose depression includes psychotic features, or who have a current or past diagnosis of a psychotic disorder
  • People who have had a substance use disorder in the past 3 months (excluding nicotine or caffeine), or who test positive on a urine drug screen (excluding cannabis)
  • People with a diagnosis of obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, post-traumatic stress disorder, or intellectual disability
  • People who are pregnant or breastfeeding
  • People with a confused or altered state of mental awareness
  • People currently taking more than 2 medications for high blood pressure
  • People with uncontrolled high blood pressure (readings above 140/90 mmHg on two separate checks at screening)
  • People with a body weight over 150kg
  • People with a history of congestive heart failure
  • People who, on the day of their visit, have unstable vital signs — including blood pressure outside the range of 90–160 mmHg, heart rate outside the range of 50–150 beats per minute, or breathing rate outside the range of 10–30 breaths per minute
  • People who have taken opioid medications within 24 hours before the study drug would be given
  • People who are acutely intoxicated at the time of their visit

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 28 July 2026
Phase 3: approximately ~65% 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

Principal Investigator: Theresa Jacob, PhD, MPH, Maimonides Medical Center

Phone: 718-283-8170

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 3
Sponsor
Theresa Jacob, PhD, MPH
Registry
ClinicalTrials.gov
Start date
16 October 2024
Est. completion
30 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS)

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: 28 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