NCT01306760

Brief Summary

The main aim of this research is to ascertain whether Ketamine would be a more effective anaesthetic for Electroconvulsive Therapy (ECT) than the standard anaesthetic. In doing so the investigators aim to examine the effect of ketamine on ratings of depressive symptoms, the number of required ECT treatments, and the effect of this anaesthetic on memory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

March 1, 2011

Last Update Submit

September 7, 2016

Conditions

Keywords

depressionelectroconvulsive therapyketamine

Outcome Measures

Primary Outcomes (1)

  • Change in depressive symptoms

    The primary outcome measure will be change in depressive symptoms after the fourth ECT treatment. This will be assessed by the change in MADRS and 17-item HDRS scores between start of treatment and this timepoint.

    After 4th treatment

Secondary Outcomes (2)

  • Cognitive side-effects

    2 months

  • Change in depressive symptoms after treatment

    2 months

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine used as the anaesthetic during ECT.

Drug: Ketamine

Propofol

ACTIVE COMPARATOR

Propofol, the standard anaesthetic, used during ECT.

Drug: Propofol

Interventions

Ketamine used as the anaesthetic during ECT.

Also known as: Ketalar
Ketamine

The standard anaesthetic used for ECT.

Also known as: Diprivan 1%
Propofol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between the ages of 18 and 65 years old
  • diagnosed with depression and being referred for ECT
  • American Society of Anesthesiologists (ASA) score of 1 or 2
  • patient receiving ECT on an informal basis (i.e. consenting to treatment and able to give informed consent)

You may not qualify if:

  • pre-existing neurological disease or cognitive impairment
  • co-morbid psychiatric diagnoses
  • pre-existing hypertension
  • severe respiratory tract disease
  • major cardiovascular disease
  • pacemakers
  • cerebrovascular disorder or malformation
  • intracranial mass lesions
  • seizure disorder
  • intracranial electrode or clips
  • intra-ocular pathology
  • endocrine or metabolic disease
  • severe hematologic disease
  • severe fracture
  • not able to give consent
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Cornhill Hospital, NHS Grampian

Aberdeen, AB25 2ZH, United Kingdom

Location

Related Publications (1)

  • Fernie G, Currie J, Perrin JS, Stewart CA, Anderson V, Bennett DM, Hay S, Reid IC. Ketamine as the anaesthetic for electroconvulsive therapy: the KANECT randomised controlled trial. Br J Psychiatry. 2017 Jun;210(6):422-428. doi: 10.1192/bjp.bp.116.189134. Epub 2017 Mar 2.

MeSH Terms

Conditions

Depression

Interventions

KetaminePropofol

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, Aromatic

Study Officials

  • Ian C Reid, PhD

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations