Can a low dose of ketamine change how people with... — Clinical Trial Details

Participants

Ages

20 – 60

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

1. Male or female
2. Aged 20-60 years old
3. Willing and able to give informed consent for participation in the study
4. Sufficiently fluent English to understand and complete the tasks
5. Registered with a GP and consents to GP being informed of participation in the study
6. Participants need to meet a number of concurrent clinical criteria: Current criteria for Major Depressive Disorder, in a current major depressive episode, as determined by the SCID-5
7. Inadequate response to at least one and no more than three antidepressant treatments; Currently taking a licensed antidepressant at a therapeutic dose for at least four weeks
8. Pre-menopausal women and male participants engaging in sex with a risk of pregnancy must agree to use a highly effective method of contraception from Screening Visit until 30 days after receiving the study medication treatment
9. Male participants must not donate sperm until 30 days after receiving the study medication
10. Participants taking non-prescription/prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety
11. Willingness to refrain from driving, cycling, or operating heavy machinery, until the following morning or a restful sleep has occurred, whichever is later
12. Willingness to refrain from drinking alcohol for 3 days before the infusion visit and one day before any of the other visits throughout the study

Exclusion Criteria

1. History of or current DSM-5 bipolar disorder, schizophrenia or emotionally unstable personality disorder (co-morbid anxiety disorders and PTSD are allowed)
2. Participants who fulfill current criteria for other comorbid disorders may still be entered if, in the opinion of the Investigator, the psychiatric diagnosis will not compromise safety or affect data quality
3. Diagnosis of a major cognitive disorder or evidence of cognitive impairment
4. Clinically significant risk of suicide
5. Participants undergoing or who have undergone electroconvulsive therapy for the treatment of the current episode of depression
6. Substance or alcohol use disorder over the past 6 months
7. Regular alcohol consumption of more than 21 units a week or excessive alcohol consumption up to three days before any in-person study visits or inability to abstain from alcohol for more than 3 days
8. Moderate cigarette use (> 10 cigarettes per day)
9. History of, or current general medical conditions that in the opinion of the Investigator may interfere with safety or scientific integrity
10. Current pregnancy, breastfeeding, planning a pregnancy, or unwillingness to practice birth control during the study
11. Clinically significant abnormalities of laboratory tests, physical examination, or ECG unless Investigator considers inclusion safe
12. Current or history of heart rhythm disorders
13. Clinically significant untreated hypertension
14. Any contraindication to MRI including claustrophobia, magnetic implants or inability to lie still for 1 hour or more
15. Previous participation in a study using the same or similar emotional processing tasks in the last three months
16. Previous lifetime use of ketamine or phencyclidine
17. Participants with planned medical treatment within the study period that might interfere with the study procedures
18. Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator.

Company

Product

Legal

Can a low dose of ketamine change how people with treatment-resistant depression remember their lives, deal with emotions, and make decisions?

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine 0.5 mg/kg

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details