Phase 2 Depression and Anxiety Trial, Recruiting NCT06512194 Sponsor: Charles Raison Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT06512194
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) and have been in a depressive episode continuously for at least 60 days at the time of screening, confirmed through a structured interview with a clinician.
  • You are in generally good physical health, with no significant medical conditions that would affect your safety or ability to take part, as determined by the screening doctor.

Who may not be able to join:

  • You have, or have a history of, a psychiatric or physical health condition that the investigator believes could be unsafe, interfere with the study, or affect the results — for example, bipolar disorder, psychosis, seizures, or heart disease.
  • A close biological family member (parent, full sibling, or child) has a history of a psychotic disorder such as schizophrenia or schizoaffective disorder.
  • You have had active thoughts of suicide with a specific plan within the last 2 weeks, as assessed through a clinical interview and a standard questionnaire.
  • You have made a suicide attempt in the last 6 months, regardless of how serious it was.
  • You currently have a diagnosis of a substance use disorder.
  • Your heart trace (ECG) at screening shows abnormal results that could increase your risk during the study, such as irregular heart rhythms or other concerns identified by the study doctor.
  • You are unwilling or unable to stop taking prescription psychiatric medications — such as antidepressants, antipsychotics, mood stabilizers, or similar drugs — for the full duration of the study, including any required period before the study begins.
  • There is any other condition, behaviour, or concern — including suspected dishonesty or difficulty following instructions — that the investigator believes makes you unsuitable for the study or could affect your safety or the reliability of the results (confirm with trial site).

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 19 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

Principal Investigator: Charles Raison, MD, Vail Health Behavioral Health

Phone: (970) 855-7374

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
Charles Raison
Registry
ClinicalTrials.gov
Start date
13 May 2025
Est. completion
1 May 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Montgomery-Åsberg Depression Rating Scale (MADRS) score; PROMIS Ability to Participate in Social Roles and Activities - Short Form 8a; Quality of Life Enjoyment and Satisfaction Questionnaire Short-Form (Q-LES-Q) 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: 19 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