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Trial registered on ANZCTR


Registration number
ACTRN12610000390088
Ethics application status
Not yet submitted
Date submitted
5/05/2010
Date registered
14/05/2010
Date last updated
4/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study for the rapid alleviation of depression in depressed alcohol dependent persons using ketamine
Scientific title
Pilot study for the rapid alleviation of depression in depressed alcohol dependent persons using ketamine
Secondary ID [1] 251692 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 257287 0
alcohol dependence 257288 0
Condition category
Condition code
Mental Health 257435 257435 0 0
Depression
Mental Health 257450 257450 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is utilising ketamine at sub-anaesthetic doses. Dose range of ketamine is 0.1 to 2mgs/kg intramuscular (IM).
All subjects are scheduled to receive 4 separate infusions of blinded ketamine/saline placebo, with each administration separated by ~7 days. IM doses of ketamine in cohort 1 will be 0.1, 0.25 and 0.5mg/kg. In cohort 2, doses will be 0.5, 1, and 2 mg/kg (note: there is a common dose level between groups). Placebo will be inserted randomly into the dosing sequence. Clinic visits for each subject are the ketamine dose procedure, Follow-up visits at day1, day 3 & day 7 post infusion (a total 4 visits per participant). For each participant there is an ascending dose subject to safety and tolerability of preceding dose. As above the 2nd cohort has a higher dose range.
Intervention code [1] 256423 0
Treatment: Drugs
Comparator / control treatment
Saline 0.9% IM as a bolus of 1ml
Control group
Placebo

Outcomes
Primary outcome [1] 258358 0
Proportion of subjects showing remission indicated by a Montgomery-Asberg Depression Rating Scale (MADRAS) <7.
Timepoint [1] 258358 0
The timepoints for the primary outcome are 2, 4, 24, 48, 72 and 168hrs post infusion of ketamine
Primary outcome [2] 258401 0
Reduction in alcohol consumption. Assessed at interview with timeline follow-back recording, Leeds Dependency Questionnaire, Negative Alcohol expectancy Questionnaire
Timepoint [2] 258401 0
2, 4, 24, 48, 72 and 168hrs post infusion of ketamine
Secondary outcome [1] 264092 0
Safety and tolerability based on self-report by interview and on Medication Side-effects Questionnaire by interview
Timepoint [1] 264092 0
baseline, post-infusion, 2, 4, 24, 48, 72 and 168h post infusion
Secondary outcome [2] 264149 0
Psychiatric symptoms: Symptom Checklist (SCL-90R), Mini International Neuropsychiatric Interview (M.I.N.I.)
Timepoint [2] 264149 0
2, 4, 24, 48, 72 and 168hrs post infusion of ketamine

Eligibility
Key inclusion criteria
Diagnostic Statistical Manual - fourth edition, text revision (DSM-IV-TR) alcohol dependence; major depression with Montgomery-Asberg Depression Rating Scale (MADRS) scores >20 able and willing to give informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current chaotic multiple substance use (excluding alcohol, and tobacco — see medication below); currently in active moderate to severe alcohol withdrawal; actively suicidal or homicidal; pregnancy, nursing or refusal to use a reliable method of birth control in female subjects; severe psychiatric symptoms for which hospitalisation is being seriously considered; evidence of significant cerebral, renal, thyroid or cardiac disease; severe liver disease or liver failure.
Medication: Disallowed medication: lamotrigine, memantine, amantadine, riluzole, N-acetylcysteine within 2 weeks; Monamine Oxidase Inhibitors (MAOIs) within 4 weeks; escalating doses of opioids.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment by referrals of eligible individuals at the local alcohol and drug service by the Principal Investigator (PI). The off-site research clinician administers the ketamine or placebo by numbered container which have been randomly allocated by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation created by a computer number sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Stage 1: Open label IM ketamine 0.5mg/kg (single dose).
Stage 2: Double blind, randomised, placebo-controlled administration of single dose IM ketamine; doses 0 (saline placebo), 0.1, 0.5 or 1mg/kg. All subjects in this stage are scheduled to receive 4 separate administrations of blinded ketamine/saline placebo, with each administration separated by ~7 days. Saline placebo will be inserted randomly into the dosing sequence
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 2616 0
New Zealand
State/province [1] 2616 0
Otago

Funding & Sponsors
Funding source category [1] 256910 0
University
Name [1] 256910 0
University of Otago Research Grant
Country [1] 256910 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 256183 0
None
Name [1] 256183 0
Address [1] 256183 0
Country [1] 256183 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258918 0
Health and Disability Ethics Committees
Ethics committee address [1] 258918 0
Ethics committee country [1] 258918 0
New Zealand
Date submitted for ethics approval [1] 258918 0
20/05/2010
Approval date [1] 258918 0
Ethics approval number [1] 258918 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31125 0
Address 31125 0
Country 31125 0
Phone 31125 0
Fax 31125 0
Email 31125 0
Contact person for public queries
Name 14372 0
Gavin Cape
Address 14372 0
Dept of Psychological Medicine
University of Otago
P.O. Box 913, Dunedin 9054, New Zealand
Country 14372 0
New Zealand
Phone 14372 0
+64 3 474 7989
Fax 14372 0
+64 3 474 7934
Email 14372 0
gavin.cape@stonebow.otago.ac.nz
Contact person for scientific queries
Name 5300 0
Gavin Cape
Address 5300 0
Dept of Psychological Medicine
University of Otago
P.O. Box 913, Dunedin 9054, New Zealand
Country 5300 0
New Zealand
Phone 5300 0
+64 3 474 7989
Fax 5300 0
+64 3 474 7934
Email 5300 0
gavin.cape@stonebow.otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.