ISRCTN - ISRCTN89575054: Resistant Depression - Ketamine Infusion Trial Evaluation

Plain English Summary

Not provided at time of registration

Trial website

http://www.red-kite.org.uk

Contact information

Type

Scientific

Primary contact

Dr Rupert McShane

ORCID ID

Contact details

Oxford Health NHS foundation trust
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
-
rupert.mcshane@oxfordhealth.nhs.uk

Additional identifiers

EudraCT number

2009-016941-25

ClinicalTrials.gov number

Protocol/serial number

8200

Study information

Scientific title

ReD-KITE: Resistant Depression - Ketamine Infusion Trial Evaluation: a phase I, dose escalation, safety study

Acronym

ReD-KITE

Study hypothesis

Several recent studies have shown that low dose intravenous ketamine infusion has a dramatic antidepressant effect in patients with treatment resistant depression.

ReDKITE aims to explore this new treatment further, by evaluating the safety and tolerability of repeated ketamine infusions in adult patients of any age with treatment resistant depression. By 'treatment resistant' we mean individuals that have received at least 2 adequate trials of anti-depressants and these have been unsuccessful.

We are interested in:
1. How well a low dose of ketamine is tolerated in people with treatment resistant depression (are there any side effects)
2. Whether ketamine improves mood for people with treatment resistant depression, and if so, how long this can last

Please note that as of 25/10/2012, the anticipated end date of this trial was updated from 01/09/2012 to 31/05/2013.

Ethics approval

Oxfordshire REC B approved on the 13th November 2009 (ref: 09/H0605/118)

Study design

Single centre non-randomised interventional phase I treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at http://www.red-kite.org.uk/id6.html

Condition

Topic: Mental Health Research Network; Subtopic: Depression; Disease: Depression

Intervention

All participants receive the same study drug. In stage 1 participants receive the drug once a week for three weeks and in stage 2 they receive the study drug twice a week for 3 weeks. The study drug is Ketalar® (ketamine) at a dose of 0.5 mg/kg. This is given intravenously over a 40 minute period. Total study duration including follow-up is 3 months 3 weeks.

Study entry: registration only

Intervention type

Drug

Phase

Phase I

Drug names

Ketamine

Primary outcome measure

Exploring the safety and tolerability of repeated doses of ketamine.

Stage 1:
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.

Stage 2:
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

Monitoring mood.

Stage 1:
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.

Stage 2:
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.

Overall trial start date

22/02/2010

Overall trial end date

31/05/2012

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 24; UK sample size: 24

Participant 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 participants 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

Recruitment start date

22/02/2010

Recruitment end date

31/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Health NHS foundation trust
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

Oxford Health NHS foundation trust (UK)

Sponsor details

Research and Development Department
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom