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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01441505




Registration number
NCT01441505
Ethics application status
Date submitted
16/09/2011
Date registered
27/09/2011
Date last updated
22/02/2013

Titles & IDs
Public title
A Study of Ketamine as an Antidepressant
Scientific title
A Study of Ketamine as an Antidepressant
Secondary ID [1] 0 0
HREC 10409
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Episode 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ketamine
Treatment: Drugs - Saline or Midazolam (active placebo)

Treatment: Drugs: Ketamine
Ketamine IV, IM, or SC will be administered in Phase I and II

Treatment: Drugs: Saline or Midazolam (active placebo)
Saline, or midazolam 0.01mg/kg will be administered in Phase I
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline on depression rating scales
Assessment method [1] 0 0
Timepoint [1] 0 0
Before, 4 hours after, and 24 hours after ketamine session
Secondary outcome [1] 0 0
Psychiatric side effects (BPRS, CADSS) and memory tests
Assessment method [1] 0 0
Timepoint [1] 0 0
Cognitive battery done before and after 3 weeks; side effects measured immediately before and 4 hours after each ketamine session in both phases.

Eligibility
Key inclusion criteria
* Satisfy DSM-IV-TR criteria for Major Depressive Episode
* 18 years or over
* Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
* Known sensitivity or contraindication to ketamine
* Recent drug abuse
* Pregnant

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

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2014
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Wesley Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Colleen K Loo, MB BS FRANZCP MD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Angelo Alonzo
Address 0 0
Country 0 0
Phone 0 0
61 02 9382 3720
Email 0 0
TMSandDCS@unsw.edu.au
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01441505