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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/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
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
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 status
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
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
Recently, interest has emerged in the use of ketamine as an antidepressant. Recent
placebo-controlled clinical trials administering a single dose and an open label trial giving
repeated doses shown that ketamine is markedly superior to placebo at reducing depression,
including in treatment-resistant patients, and that its antidepressant effects have a very
rapid onset.

This clinical study consists of two phases. In Phase I, participants who satisfy inclusion
criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline, or
0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase II,
they will receive repeated sessions of ketamine at variable doses over three weeks. During
both phases, mood, psychiatric, and neuropsychological outcomes will be measured.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01441505
Trial related presentations / publications
aan het Rot M, Collins KA, Murrough JW, Perez AM, Reich DL, Charney DS, Mathew SJ. Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):139-45. doi: 10.1016/j.biopsych.2009.08.038.
Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
Diazgranados N, Ibrahim L, Brutsche NE, Newberg A, Kronstein P, Khalife S, Kammerer WA, Quezado Z, Luckenbaugh DA, Salvadore G, Machado-Vieira R, Manji HK, Zarate CA Jr. A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry. 2010 Aug;67(8):793-802. doi: 10.1001/archgenpsychiatry.2010.90.
Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.
Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.
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
Angelo Alonzo
Address 0 0
Country 0 0
Phone 0 0
61 02 9382 3720
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01441505