Can a low dose of ketamine change how people with treatment-resistant depression remember their lives, deal with emotions, and make decisions?
- Conditions
- Major depressive disorderMental and Behavioural Disorders
- Registration Number
- ISRCTN68107842
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
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
1. History of /or current DSM.5 bipolar disorder, schizophrenia or emotionally unstable personality disorder [co-morbid anxiety disorders (including agoraphobia, generalized anxiety disorder, social anxiety disorder and panic disorder) and Posttraumatic Stress Disorder (PTSD) are allowed]
2. Participants who fulfill current criteria for other comorbid disorders may still be entered into the study, 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 of the 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 the safety of the participant or the scientific integrity of the study
10. Current pregnancy (as determined by urine pregnancy test), breastfeeding, planning a pregnancy, or unwillingness to practice birth control during the study
11. Clinically significant abnormalities of laboratory tests, physical examination, or ECG. A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
12. Current or history of heart rhythm disorders
13. Clinically significant untreated hypertension
14. Any contraindication to MRI including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method