NCT01582945

Brief Summary

Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD). This is an open-label study (pilot).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable major-depressive-disorder

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

Study Start

First participant enrolled

April 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 20, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

April 17, 2012

Results QC Date

March 2, 2017

Last Update Submit

April 18, 2017

Conditions

Major Depressive Disorder

Keywords

Treatment resistantsuicidal ideationmajor depressive disorder

Outcome Measures

Primary Outcomes (1)

  • Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)

    Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.

    Weekly for total duration of 4 months

Study Arms (1)

Ketamine IV

EXPERIMENTAL

Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks

Drug: Ketamine

Interventions

KetamineDRUG

Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Ketamine IV

Eligibility Criteria

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

You may qualify if:

  • Outpatients with severe treatment-resistant MDD
  • Currently depressed
  • Currently under regular psychiatric care
  • On an aggressive antidepressant regimen, stable for 4 weeks

You may not qualify if:

  • No history of other major psychiatric illnesses, including bipolar disorder
  • No history of psychosis
  • No history of drug abuse
  • No major medical illness or unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depression Clinical and Research Program - MGH

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Ionescu DF, Swee MB, Pavone KJ, Taylor N, Akeju O, Baer L, Nyer M, Cassano P, Mischoulon D, Alpert JE, Brown EN, Nock MK, Fava M, Cusin C. Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study. J Clin Psychiatry. 2016 Jun;77(6):e719-25. doi: 10.4088/JCP.15m10056.

    PMID: 27232360RESULT

  • Cusin C, Ionescu DF, Pavone KJ, Akeju O, Cassano P, Taylor N, Eikermann M, Durham K, Swee MB, Chang T, Dording C, Soskin D, Kelley J, Mischoulon D, Brown EN, Fava M. Ketamine augmentation for outpatients with treatment-resistant depression: Preliminary evidence for two-step intravenous dose escalation. Aust N Z J Psychiatry. 2017 Jan;51(1):55-64. doi: 10.1177/0004867416631828.

    PMID: 26893373RESULT

MeSH Terms

Conditions

Depressive Disorder, MajorSuicidal Ideation

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Cristina Cusin
Organization
Massachusetts General Hospital
ccusin@mgh.harvard.edu
6177266421

Study Officials

  • Cristina Cusin, MD

    MGH Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor HMS

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 23, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

April 20, 2017

Results First Posted

April 20, 2017

Record last verified: 2017-04

Locations

US(1)