Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing Ketamine (0.5 mg/kg) for Treatment Resistant Depression

The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone. We aim to find out whether participants who receive both treatments: 1.

Official registry: https://clinicaltrials.gov/study/NCT07801703 · The Royal's Institute of Mental Health Research · enrollment listed as 60

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Ketamine (0.5 mg/kg), or Behavioural Activation Therapy. The registry lists allocation as randomized. The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone.

They plan to enroll about 60 people at Ottawa. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Optimizing the Synergy Between Behavioural Activation Therapy and Intravenous Ketamine for Treatment-Resistant Depression

Interventions: Ketamine (0.5 mg/kg), Behavioural Activation Therapy

Primary outcome (registry wording): Change in MADRS from Baseline

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Age 18-65 at Screening
  • Meeting criteria for major depressive disorder (major depression), in a major depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5)
  • Have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current depressive episode
  • Currently in a moderate to severe depressive episode, with a minimum MADRS score of ≥22 at Screening
  • Be under the care of a designated health care provider (e.g., family physician or psychiatrist) to follow their care after the completion of the study
  • Willing to maintain stable doses of concomitant psychotropic medications throughout the study
  • Willing to abstain from taking prohibited medications on the days of treatment (i.e., for 12 hours prior to treatment) as per study physician instruction (e.g., benzodiazepines, cannabis)

Public study contact (from the registry)

Research Coordinator

613-722-6521

suwojcik@theroyal.ca

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07801703 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07801703?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07801703?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary