Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001011077
Ethics application status
Approved
Date submitted
9/11/2010
Date registered
18/11/2010
Date last updated
23/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Rapid depression treatment in cancer patients
Scientific title
Effects of low dose intramuscular ketamine on depression ratings in depressed patients with cancer in palliative care
Secondary ID [1] 253055 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 258618 0
Cancer 258619 0
Condition category
Condition code
Mental Health 258762 258762 0 0
Depression
Cancer 258763 258763 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Stage 1: ketamine 1mg/kg single dose, open label. Patients who show a response to ketamine in Stage 1 are eligible to enter Stage 2.
- Stage 2: ketamine 1mg/kg multiple doses repeated at approximately weekly intervals, open label. Patients may continue to receive ketamine as long as beneficial effects on mood persist
- After completion of Stage 1, enrollment in Stage 3 will commence. Patients who have participated in Stages 1/2 are not eligible to enter Stage 3.
- Stage 3: patients will be randomized to one of 3 ketamine dose arms (0.1mg/kg, 0.5mg/kg, 1.0mg/kg IM), single dose, double blind
Intervention code [1] 257579 0
Treatment: Drugs
Comparator / control treatment
0.1 vs 0.5 vs 1.0mg/kg
Control group
Dose comparison

Outcomes
Primary outcome [1] 259624 0
Montgomery-Asberg Depression Rating Scale (MADRS). Analysis will be on mean MADRS scores at each time point; change from baseline in MADRS; proportion of subjects showing response (>50% reduction at each timepoint) and remission (MADRS <7) at each timepoint). Relapse post-injection is a MADRS score >20.
Timepoint [1] 259624 0
At baseline, 1, 2, 4, 24, 48, 72 and 168h post injection
Secondary outcome [1] 266279 0
HADS and Demoralization scales
Timepoint [1] 266279 0
Baseline, 24 hours post injection
Secondary outcome [2] 266280 0
Safety and tolerability based on self-report (via clinical interview).
Timepoint [2] 266280 0
Up to 168 hours post injection

Eligibility
Key inclusion criteria
Male or female; any cancer type; receiving palliative care; life expectancy >3 months.
Major depression with baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores >20.
Advanced (incurable cancer), adequate hepatic/renal function.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of cerebral metastases, ECOG performance status <4, not on other experimental medication. Current use of ketamine for analgesia.

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)
Stage 1 and 2 - open label (to ensure ketamine has an antidepressant effect)
Stage 3: parallel-group double blind dose response (0.1 vs 0.5 vs 1.0mg/kg IM). Patients will be allocated blinded dose of ketamine based on enrollment number. These will be allocated sequentially. Study medication will be prepared by staff not involved with dosing or assessment of outcomes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer - generated random code
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3028 0
New Zealand
State/province [1] 3028 0

Funding & Sponsors
Funding source category [1] 258034 0
University
Name [1] 258034 0
University of Otago
Country [1] 258034 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Psychological Medicine
PO Box 917
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 257224 0
Hospital
Name [1] 257224 0
Dunedin Public Hospital
Address [1] 257224 0
Great King St
Dunedin 9054
Country [1] 257224 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260026 0
Lower South Regional Ethics Committee
Ethics committee address [1] 260026 0
PO Box 5849
Dunedin 9016
Ethics committee country [1] 260026 0
New Zealand
Date submitted for ethics approval [1] 260026 0
09/11/2010
Approval date [1] 260026 0
21/12/2010
Ethics approval number [1] 260026 0

Summary
Brief summary
Low dose ketamine has been shown to produce rapid (within hours) improvements in mood in patients with major depression. We plan to test ketamine in depressed patients with advanced cancer, for whom rapid improvement in mood may be particularly important in the context of limited life expectancy. The study has 3 stages: Stage 1: showing that ketamine improves mood; Stage 2: showing this effect can be maintained after repeated (weekly) dosing); and Stage 3: exploring the relationship between dose and improvement in mood.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31892 0
Address 31892 0
Country 31892 0
Phone 31892 0
Fax 31892 0
Email 31892 0
Contact person for public queries
Name 15139 0
Paul Glue
Address 15139 0
Department of Psychological Medicine
PO Box 913
Dunedin 9054
Country 15139 0
New Zealand
Phone 15139 0
64 3 470 3867
Fax 15139 0
Email 15139 0
[email protected]
Contact person for scientific queries
Name 6067 0
Paul Glue
Address 6067 0
Department of Psychological Medicine
PO Box 913
Dunedin 9054
Country 6067 0
New Zealand
Phone 6067 0
64 3 470 3867
Fax 6067 0
Email 6067 0
[email protected]

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.