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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00680433




Registration number
NCT00680433
Ethics application status
Date submitted
16/05/2008
Date registered
20/05/2008
Date last updated
29/03/2013

Titles & IDs
Public title
Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)
Scientific title
A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
Secondary ID [1] 0 0
HREC 07281
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

Experimental: Active - Ketamine

Placebo comparator: Placebo - Saline (placebo)


Treatment: Drugs: Ketamine
Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.

Treatment: Drugs: Saline
Saline (placebo) will be administered after the normal anaesthetic agents in ECT.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Memory tests
Timepoint [1] 0 0
Before ECT, after 6 ECT treatments, at the end of the ECT course
Secondary outcome [1] 0 0
Depression rating scale
Timepoint [1] 0 0
Before ECT, after each week of treatment, at the end of the ECT course

Eligibility
Key inclusion criteria
* Satisfy DSM-IV-TR criteria for Major Depressive Episode
* 18 years or over
* Does not have a diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
* No known sensitivity to ketamine
* No ECT in the last 3 months
* No drug or alcohol abuse in the last 12 months
* Able to give informed consent
* Score at least 24 on Mini Mental State Examination
Minimum age
18 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 administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Wesley Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Northside Clinic, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Wesley Mission
Address [1] 0 0
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
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

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/NCT00680433