Treatment Resistant Depression study: Ketamine
Official title Behavioural Activation Therapy and Ketamine for Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT07801703
What this study is testing
What is Ketamine (0.5 mg/kg)?
Ketamine (0.5 mg/kg) is an investigational medicine, given as a once-weekly IV infusion (through a vein), being studied as a potential treatment for treatment resistant depression.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- English speaking
- Age 18-65 at Screening
- Meeting criteria for major depressive disorder (MDD), in a major depressive episode without psychotic symptoms according to the Diagnostic and...
- Have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in...
- Currently in a moderate to severe depressive episode, with a minimum MADRS score of ≥22 at Screening
You likely can't join if
- Body mass index (BMI) ≥35
- Depression secondary to a stroke, cancer, or other clinically significant medical illness, per study physician judgement
- Not medically cleared to receive ketamine treatment due to presence of clinically relevant disease, per study physician judgement (e.g., uncontrolled...
- Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study, as assessed during...
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis
- Current and/or recent history (\<12 months) of substance use disorder/dependence (except for alcohol, cannabis, caffeine or nicotine) as defined by...
See the full eligibility criteria
- English speaking
- Age 18-65 at Screening
- Meeting criteria for major depressive disorder (MDD), 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)
- Able to secure a ride/chaperone home from all ketamine infusions.
- Body mass index (BMI) ≥35
- Depression secondary to a stroke, cancer, or other clinically significant medical illness, per study physician judgement
- Not medically cleared to receive ketamine treatment due to presence of clinically relevant disease, per study physician judgement (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary...
- Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study, as assessed during the Screening Visit medical clearance
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis
- Current and/or recent history (\<12 months) of substance use disorder/dependence (except for alcohol, cannabis, caffeine or nicotine) as defined by DSM-5 criteria
- Current and/or recent history (\<6 months) of cannabis use disorder as defined by DSM-5 criteria, or unable to abstain from using cannabis 12 hours before and 12 hours after each ketamine infusion
- Current and/or recent history (\<6 months) of alcohol use disorder as defined by DSM-5 criteria, or unable to abstain from using alcohol 12 hours before and 12 hours after each ketamine infusion
- Concurrent use of ketamine or psychedelics in any form
- A previous history or known diagnosis of major neurocognitive disorder
- Known or suspected history of intolerance, allergy or hypersensitivity to ketamine
- Any other condition or circumstance that, in the opinion of the QI/study physicians, would adversely affect the participant's ability to complete the study procedures or its measures
- Concurrent psychotherapy treatment outside the clinical trial. A participant may opt to pause or terminate their current ongoing psychotherapy to participate in the study, at their own discretion.
- Concurrent active electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) therapy.
The study team makes the final eligibility decision.
Where it is enrolling
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.