Trial from

For full trial details, please see the original record at

Trial ID
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Ketamine Trial for the Treatment of Depression
Scientific title
Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase
Secondary ID [1] 0 0
HREC 15009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unipolar Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: drugs - Ketamine
Treatment: drugs - Placebo

Active Comparator: Treatment arm - Ketamine

Placebo Comparator: Placebo arm - Placebo

Treatment: drugs: Ketamine

Treatment: drugs: Placebo

Intervention code [1] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Timepoint [1] 0 0
4 weeks

Key inclusion criteria
Individuals will be eligible for enrolment on the basis of:

- major depressive disorder for at least three months duration

- an inadequate response to at least 2 adequate antidepressants

- MADRS = 20

Patients will be excluded on the basis of:

- History of psychosis

- History of bipolar disorder

- Any unstable medical or neurologic condition

- Any Axis I disorder other than MDD judged to be primary presenting problem

- Planned major changes to psychotropic medication

- Significant risk of suicide

- Planned or probable use of ECT

- Age under 16 years, or 16-17 years without parental consent

- Substance abuse or dependence in previous 6 months

- Any history of abuse of ketamine or phencyclidine

- Contraindication to the use of ketamine

- Planned use of ketamine

- Women of childbearing potential not taking reliable contraception

- Likely non-compliance with trial treatment

- Other condition judged by the treating clinician as likely to impact on the ability of
the participant to complete the trial
Minimum age
16 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Brain & Mind Research Institute (BMRI), University of Sydney - Camperdown
Recruitment hospital [2] 0 0
Black Dog Institute, University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
The University of New South Wales
Other collaborator category [1] 0 0
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
This study is a Randomized Controlled Trial, investigating the safety and efficacy of
administration of ketamine as a potential treatment for depression.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Colleen K Loo, MBBS, MD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Veronica Galvez Ortiz, MBBS, MD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries
Contact person responsible for updating information