Resistant Depression - Ketamine Infusion Trial Evaluatio

Phase 1

Completed

Conditions: Topic: Mental Health Research Network
Subtopic: Depression
Disease: Depression
Mental and Behavioural Disorders
Depressive episode

Registration Number: ISRCTN89575054

Lead Sponsor: Oxford Health NHS foundation trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

Inclusion Criteria

Current inclusion criteria as of 25/10/2012:
1. Suffering from Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) major depression (uni-polar or bi-polar)
2. Current or past history of lack of response to two adequate antidepressant trials operationally defined using the Antidepressant Treatment History Form (ATHF)
3. Medically fit to receive ketamine in opinion of Consultant Anaesthetist
4. Aged over 18 years, either sex
5. Willing and competent to give informed consent for participation in the study
6. Good understanding of English
7. If a daypatient, must be accompanied until 6 am on the day after each treatment by a competent adult
8. Participant has previously been assessed by a psychiatrist.
9. Able (in the Investigators opinion) and willing to comply with all study requirements.
10. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study and any clinically significant changes.

Previous inclusion criteria until 25/10/2012:
1. Suffering from Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) major depression
2. Score of 18 or higher on Hamilton Depression Rating Scale (HDRS) at screening and baseline
3. Current or past history of lack of response to two adequate antidepressant trials operationally defined using the Antidepressant Treatment History Form (ATHF)
4. Depression to a level that they are being considered for alternative more intense treatment such as electroconvulsive therapy (ECT)
5. Medically fit to receive ketamine in opinion of Consultant Anaesthetist
6. Aged over 18 years, either sex
7. Competent to consent to research
8. Good understanding of English
9. If a daypatient, must be accompanied until 6 am on the day after each treatment by a competent adult

Exclusion Criteria

Current exclusion criteria as of 25/10/2012:
1. Schizophrenia or schizoaffective disorder
2. Dementia or diagnosis of mild cognitive impairment
3. Closed angle glaucoma
4. Individuals with a poor understanding of English
5. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
6. Participant who is terminally ill
7. Known hypersensitivity to the drug Ketamine
8. Uncontrolled hypertension
9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant?s ability to participate in the study.

Previous exclusion criteria until 25/10/2012:
1. Serious suicide risk as judged by the treating consultant
2. Schizophrenia or schizoaffective disorder
3. History of illegal substance misuse
4. Alcohol dependence in last 2 years
5. Dementia or diagnosis of mild cognitive impairment
6. Antidepressant-induced mania
7. Manic episode in last 2 years
8. Closed angle glaucoma
9. Neuropathic pain
10. On Section of Mental Health Act
11. If daypatient and cannot be accompanied by a competent caregiver
12. Individuals with a poor understanding of english
13. Participant does not have/loses capacity

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exploring the safety and tolerability of repeated doses of ketamine. <br><br>Stage 1: <br>Measured at baseline, day 0 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes) day 6, day 7 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 13, day 14 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes) day 21, day 28, day 42, day 70 and day 98.<br><br>Stage 2: <br>Measured at baseline, day 0 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 3 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 6, day 7 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 10 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 13, day 14 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 17, day 21, day 28, day 42, day 70 and day 98.

Secondary Outcome Measures

Name	Time	Method
Monitoring mood.<br><br>Stage 1: <br>Measured at baseline, day 0 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes) day 6, day 7 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 13, day 14 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes) day 21, day 28, day 42, day 70 and day 98.<br><br>Stage 2: <br>Measured at baseline, day 0 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 3 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 6, day 7 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 10 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 13, day 14 (-20, 20, 40, 60, 80, 100, 120 and 360 minutes), day 17, day 21, day 28, day 42, day 70 and day 98.