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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02401139




Registration number
NCT02401139
Ethics application status
Date submitted
24/03/2015
Date registered
27/03/2015
Date last updated
30/03/2023

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
Depression

Intervention/exposure
Study type
Interventional
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

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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
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
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT02401139
Trial related presentations / publications
Public notes

Contacts
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02401139