Depression and Anxiety Trial, Recruiting NCT07563868 Sponsor: Massachusetts General Hospital Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT07563868
Recruiting Not Applicable

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:

  • People aged 18 or older at the time of enrolling in the study
  • People who are able to understand the study and agree to take part
  • People who speak and read English fluently
  • People who are willing to have their coaching sessions recorded using an approved, privacy-protected video platform
  • People whose depression symptom score (measured by a questionnaire called the QIDS-SR) is at a moderate or higher level at the screening visit
  • People who have been diagnosed with a depressive disorder at some point in their lifetime, confirmed using a structured clinical interview called the MINI
  • People who are in the ongoing maintenance phase of ketamine or esketamine treatment, meaning they have already completed the initial intensive treatment course
  • People who have completed at least 3 maintenance treatments before the screening visit, and whose QIDS-SR scores from those 3 most recent treatments show at least moderate depression severity
  • People who are currently receiving maintenance ketamine (given through a drip) or esketamine (given as a nasal spray) at the MGH Ketamine Clinic, have had at least one treatment in the past 8 weeks, and plan to continue as an active patient there for the full duration of the study
  • People who already have an established relationship with a mental health provider (such as a psychiatrist or therapist), and who agree to sign a release of information form if that provider is outside the Mass General Brigham healthcare system

Who may not be able to join:

  • People with an unstable medical condition, as determined by the study clinician
  • People with significant cognitive difficulties that affect their ability to carry out daily activities and would interfere with taking part in the study, as judged by the study clinician
  • People who have started a new course of psychotherapy within the past 3 months
  • People whose situation or circumstances make participation unsafe or unsuitable, in the judgment of the Principal Investigator
  • People with a psychiatric condition other than depression that is currently the main or most significant concern, or that is not sufficiently stable, and would interfere with study participation, as judged by the study clinician
  • People who are planning to switch between IV ketamine and intranasal esketamine (or vice versa) at any point during the study
  • People assessed by the study clinicians as having current thoughts of suicide with a plan to act within the next 6 months
  • People whose depression symptom score improves by 25% or more between the screening visit and the baseline 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 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Maren Nyer, PhD, Massachusetts General Hospital and Harvard Medical School

Phone: 6176434897

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.; To assess the acceptability of adjunctive coaching during ketamine/esketamine maintenance treatment.

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: 15 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