Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000566538
Ethics application status
Approved
Date submitted
11/05/2015
Date registered
2/06/2015
Date last updated
19/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Studying the antidepressant effects of intravenous ketamine in patients with major depressive disorder
Scientific title
Studying the antidepressant effects of intravenous ketamine in patients with major depressive disorder
Secondary ID [1] 286674 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 295015 0
Condition category
Condition code
Mental Health 295278 295278 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous Ketamine 0.5mg/kg infusion once per week for 2 weeks
Intervention code [1] 291824 0
Treatment: Drugs
Comparator / control treatment
Comparator group: Intravenous Scopolamine 4 mcg/kg infusion once per week for 2 weeks
Control group: Intravenous Saline (placebo) infusion once per week for 1 week
Control group
Placebo

Outcomes
Primary outcome [1] 295025 0
Change in depression severity pre- and post-intervention using Montgomery-Asberg Depression Rating Scale
Timepoint [1] 295025 0
Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.
Secondary outcome [1] 314615 0
Clinical Global Impressions Scale
Timepoint [1] 314615 0
Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.
Secondary outcome [2] 314900 0
Quick Inventory of Depressive Symptamatology
Timepoint [2] 314900 0
Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.
Secondary outcome [3] 314901 0
Brief Psychiatric Rating Scale
Timepoint [3] 314901 0
Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.
Secondary outcome [4] 319010 0
Young Mania Rating Scale
Timepoint [4] 319010 0
Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.
Secondary outcome [5] 319011 0
Hamilton Anxiety Rating Scale
Timepoint [5] 319011 0
Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.
Secondary outcome [6] 319012 0
Functional connectivity with magnetic resonance imaging
Timepoint [6] 319012 0
Baseline and post second infusion.

Eligibility
Key inclusion criteria
- Major depressive episode according to DSM-IV-TR Disorders
- Montgomery-Asberg Depression Rating Scale score of at least 20
- On stable doses of oral antidepressant medication
- Ability to provide informed consent
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any unstable medical condition or clinically relevant abnormality that is likely to compromise study conduct, evaluation or safety
- Schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, eating disorder, substance-related disorders
- Drug allergy to ketamine or scopolamine
- Use of adjunct medications for depression and TCAs
- Pregnant or breast-feeding women
- Inability to follow procedures in the study protocol for any reason

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6874 0
Singapore
State/province [1] 6874 0

Funding & Sponsors
Funding source category [1] 291254 0
University
Name [1] 291254 0
National University of Singapore
Country [1] 291254 0
Singapore
Primary sponsor type
University
Name
National University of Singapore
Address
National University of Singapore
1E Kent Ridge Road, NUHS Tower Block, Level 11, Singapore 119228
Country
Singapore
Secondary sponsor category [1] 289930 0
Hospital
Name [1] 289930 0
National University Hospital
Address [1] 289930 0
National University Hospital
1E Kent Ridge Road, NUHS Tower Block, Level 9, Singapore 119228
Country [1] 289930 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292818 0
NHG Domain Specific Review Board
Ethics committee address [1] 292818 0
Ethics committee country [1] 292818 0
Singapore
Date submitted for ethics approval [1] 292818 0
Approval date [1] 292818 0
30/04/2015
Ethics approval number [1] 292818 0

Summary
Brief summary
This randomised controlled trial aims to study the add-on effects of intravenous ketamine to standard oral antidepressant treatment. We hypothesise that this combination may bring about more rapid antidepressant effects compared with oral antidepressant treatment alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57134 0
Dr Johnson Fam
Address 57134 0
Department of Psychological Medicine, NUHS Tower Block Level 9, 1E Lower Kent Ridge Road, Singapore 119 228
Country 57134 0
Singapore
Phone 57134 0
+65 67795555
Fax 57134 0
Email 57134 0
[email protected]
Contact person for public queries
Name 57135 0
Dr Johnson Fam
Address 57135 0
Department of Psychological Medicine, NUHS Tower Block Level 9, 1E Lower Kent Ridge Road, Singapore 119228
Country 57135 0
Singapore
Phone 57135 0
+65 67795555
Fax 57135 0
Email 57135 0
[email protected]
Contact person for scientific queries
Name 57136 0
Dr Johnson Fam
Address 57136 0
Department of Psychological Medicine, NUHS Tower Block Level 9, 1E Lower Kent Ridge Road, Singapore 119228
Country 57136 0
Singapore
Phone 57136 0
+65 67795555
Fax 57136 0
Email 57136 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.