Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000573550
Ethics application status
Approved
Date submitted
21/05/2015
Date registered
3/06/2015
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Date results provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled study of an N-Methyl-D-Aspartate antagonist in major depression
Scientific title
A randomised, double blind, active placebo-controlled crossover trial to evaluate the short term efficacy of an N-Methyl-D-Aspartate antagonist for patients with treatment resistant depression
Secondary ID [1] 286248 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 294304 0
Major depressive disorder 295202 0
Condition category
Condition code
Mental Health 294627 294627 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ketamine IV. – bolus dose 0.25mg/kg then infusion at 0.25 mg/kg/hr for 45 minutes
Washout 3 weeks. Follow-ups at 1,7,14,21 days.
Study duration 42 days.
Intervention code [1] 291266 0
Treatment: Drugs
Comparator / control treatment
Remifentanil IV. 0.1 ng /ml according to the Minto pharmacokinetic model for 8 minutes
Control group
Active

Outcomes
Primary outcome [1] 294390 0
Montomery-Asberg Depressive Rating Scale (MADRS)
Timepoint [1] 294390 0
4 hours post administration
Secondary outcome [1] 313183 0
BDNF plasma concentration
Timepoint [1] 313183 0
4 hours post intervention
Secondary outcome [2] 314963 0
Functional connectivity measured with electroencephalography (EEG)
Timepoint [2] 314963 0
4 hours 30 minutes

Eligibility
Key inclusion criteria
* Participant is willing and able to give informed consent for participation in the trial.
* Male or female, aged 18 years or above and less than 60.
* In the Investigators’ opinion, is able and willing to comply with all trial requirements.
* Major depressive disorder for at least three months, as assessed by a Clinical Interview using DSM-IV criteria
* MADRS >20
* An inadequate response to at least two antidepressants courses (Antidepressant Treatment History Form) one of which can include the current episode
* Stable on antidepressant medication for four weeks prior to Study Day 1
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
* Significant renal or hepatic impairment.
* Cardiovascular conditions including abnormal heart rate and blood pressure checked at screening.
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
* History of psychosis
* Any unstable medical or neurologic condition.
* Planned major changes to psychotropic medication.
* Imminent risk of suicide as determined by the CSSRS.
* Planned or probable use of ECT.
* Substance abuse or dependence in previous 6 months.
* Any history of abuse of ketamine or phencyclidine.
* Contraindication to the use of ketamine according to manufacturer guidelines.
* Planned use of ketamine, for example, for pain control.
* Unable to fast for four hours prior to each administration of trial drug.
* Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.
* Body-weight <50kg or >120kg.
* Current use of NMDA antagonist medications (e.g. memantine / amantadine / rimantadine / lamotrigine / dextromethorphan/procyclidine).
* Inability to speak or read English.
* Contraindications for MRI scanning

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 / Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
27/10/2016
Date of last participant enrolment
Anticipated
1/12/2018
Actual
16/08/2018
Date of last data collection
Anticipated
1/02/2019
Actual
5/10/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 6685 0
New Zealand
State/province [1] 6685 0

Funding & Sponsors
Funding source category [1] 290809 0
Government body
Name [1] 290809 0
Royal Society of New Zealand
Country [1] 290809 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 289496 0
None
Name [1] 289496 0
Address [1] 289496 0
Country [1] 289496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292435 0
HDEC Northern
Ethics committee address [1] 292435 0
Ethics committee country [1] 292435 0
New Zealand
Date submitted for ethics approval [1] 292435 0
10/03/2015
Approval date [1] 292435 0
14/05/2015
Ethics approval number [1] 292435 0

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

Contacts
Principal investigator
Name 55266 0
Dr Suresh Muthukumaraswamy
Address 55266 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 55266 0
New Zealand
Phone 55266 0
+64 9373 7599 ext:85398
Fax 55266 0
Email 55266 0
sd.muthu@auckland.ac.nz
Contact person for public queries
Name 55267 0
Suresh Muthukumaraswamy
Address 55267 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 55267 0
New Zealand
Phone 55267 0
+64 9373 7599 ext:85398
Fax 55267 0
Email 55267 0
sd.muthu@auckland.ac.nz
Contact person for scientific queries
Name 55268 0
Suresh Muthukumaraswamy
Address 55268 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 55268 0
New Zealand
Phone 55268 0
+64 9373 7599 ext:85398
Fax 55268 0
Email 55268 0
sd.muthu@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseKetamine improves short-term plasticity in depression by enhancing sensitivity to prediction errors.2020https://dx.doi.org/10.1016/j.euroneuro.2020.07.009
N.B. These documents automatically identified may not have been verified by the study sponsor.