Ketamine Trial for the Treatment of Depression | NCT02401139

Studies
Ketamine Trial for the Treatment of Depression

NCT02401139

Sponsor

The University of New South Wales

Status

Completed

Last Update Posted

Mar 30, 2023Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Unipolar Depression

Interventions

Ketamine
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 24, 2015

First Submission Date that Met QC Criteria

Mar 26, 2015

First Posted Date

Mar 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2023

Last Update Posted Date

Mar 30, 2023Actual

Name	Class
University of Sydney	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Active Comparator	Ketamine	Drug: Ketamine
Placebo arm	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketamine	Drug		Treatment arm
Placebo

Measure	Description	Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)		4 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Colleen K Loo, MBBS, MD	University of New South Wales	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brain & Mind Research Institute (BMRI), University of Sydney		Camperdown	New South Wales	2050	Australia

ID	Term
D003866	Depressive Disorder

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided