RightFit
Not yet recruitingPhase 2

Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits, 2 visits, 7 visits
  • Time periods mentioned: 7 days
  • Procedures mentioned: MRI scans, Questionnaires, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators are analyzing the brain using functional magnetic resonance imaging (fMRI), a method used to measure brain activity."
  • "Participants will: * Visit the facilities 6-8 times * Complete 2 MRI brain scans * Complete 3-4 psychotherapy sessions * Receive 1-2 doses of ketamine * Complete online surveys between 3-4 visits"
  • "The patients will undergo 2 scanning visits (baseline and follow-up)."
  • "They will also receive 1-2 treatments of ketamine IM injection and 3-4 psychotherapy sessions."
  • "Patients with TRD will be asked to come to the PI's lab for 2 visits, and 6 in the Department of Psychiatry."
  • "Visits 4 and 6 will be the ketamine IM injection sessions."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

The goal of this clinical trial is to understand the effect of ketamine on the brain in people with treatment-resistant depression (TRD). TRD occurs in around a third of people with depression and leads to higher suicide rates compared to those with major depressive disorder. A desperate need for a rapid acting antidepressant drug (RAAD) is needed to help improve quality of life for people with TRD. Ketamine has been shown to be a RAAD, and esketamine (a form of ketamine) was approved by the FDA to treat TRD. Ketamine has been known to cause dissociative experiences, that can lead to an increase in the "Openness to Experience" personality trait and psychological flexibility that occurs at "peak experience". This has been shown to improve mental health conditions and lower suicide risk. This study aims to further understand if there is a connection between this new change of mind and changes in brain activity. Ketamine has been shown to improve brain plasticity as well, specifically in the frontolimbic region of the brain, an area associated with depression. The investigators are analyzing the brain using functional magnetic resonance imaging (fMRI), a method used to measure brain activity. The frontolimbic region is also associated with cognitive flexibility and emotional processing, an important hurdle in treating TRD. Due to this, the investigators are pairing the ketamine treatment with psychotherapy sessions, to guide the processing experience, which can lead to higher emotional flexibility. The main questions this study aims to answer are: * Are frontolimibic plasticity circuitry changes associated with openness to experience and peak experience? * Is it feasible to recruit and retain people through a two-month KAP study? * Is the structure of the study effective for treating TRD? Participants will: * Visit the facilities 6-8 times * Complete 2 MRI brain scans * Complete 3-4 psychotherapy sessions * Receive 1-2 doses of ketamine * Complete online surveys between 3-4 visits

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria The following inclusion criteria must be met for all subjects to be considered eligible to participate: 1. 18 years old or older 2. Able to speak, read, and understand English 3. In generally stable health 4. Must have treatment resistant depression, as defined as scoring in the moderate or above range on the HDRS and having failed two adequate trials of antidepressants in the last two years. Exclusion Criteria General exclusion criteria for all subjects include: 1. Uncontrolled hypertension 2. Impaired cardiac status a. Abnormal ECG report in the last month prior to screening 3. Chronic Obstructive Pulmonary Disease 4. Congenital Long QT Syndrome 5. ≥265lbs or 120kg 6. Severe obesity (BMI ≥40) 7. Increased intracranial or cerebrospinal pressure 8. Pregnancy or breastfeeding 9. Hyperthyroidism 10. Prior adverse response to ketamine, including allergic reaction 11. Symptoms of psychosis or prodromal phase 12. Severe personality disorder 13. Autistic Spectrum Disorders 14. Bipolar disorder 15. History of substance abuse, defined as a score of three or more on Drug Abuse scale (prior use of psychedelics allowed) 16. Past-year suicide attempt or ongoing ideation with intent to act 17. All exclusion criteria for magnetic resonance imaging safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia. 18. Taking medications that could interact with ketamine. Examples include but are not limited to: any types of stimulants, aripiprazole, diphenhydramine, hydromorphone, escitalopram, fluoxetine, alprazolam, and sertraline. Each subject's current medications will be evaluated for interactions with ketamine before admission into the trial.

Study sites (1)

NY