NCT02522377

Brief Summary

In this proof of concept study, the investigators plan to administer iv ketamine interleaved with ECT days. Patients with treatment resistant depression who are deemed to be eligible for ECT treatment will randomly be assigned to either ketamine or active placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

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

August 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 29, 2019

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

August 7, 2015

Results QC Date

June 27, 2019

Last Update Submit

August 28, 2019

Conditions

Treatment Resistant DepressionMajor Depressive DisorderSevere Depression

Keywords

KetamineElectroconvulsive TherapyMajor Depressive DisorderTreatment Resistant Depressionelectroconvulsive treatmentSevere depression

Outcome Measures

Primary Outcomes (2)

  • Hamilton Depression Rating Scale (HAMD-17) at Last Infusion

    Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.

    visit 17

  • Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion

    Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60

    visit 17

Secondary Outcomes (4)

  • Montreal Cognitive Assessment (MOCA) at Last Infusion

    visit 17

  • Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion

    visit 17

  • Controlled Oral Word Association Test (COWAT) at Last Infusion

    visit 17

  • Responder Rate on HAMD-17 by Last Infusion

    visit 17

Study Arms (2)

Ketamine Infusions

EXPERIMENTAL

Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.

Drug: Ketamine

Midazolam

ACTIVE COMPARATOR

Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.

Drug: Midazolam

Interventions

KetamineDRUG

inter venous injections

Also known as: Ketalar, Calypsol, Ketanest, Tekam
Ketamine Infusions
MidazolamDRUG

inter venous injections

Also known as: Dormicum, Hypnovel, Versed
Midazolam

Eligibility Criteria

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

You may qualify if:

  • Males/females at least 18 years of age but no older than 65 years of age
  • Meet Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Major Depression or Bipolar Disorder, depressed phase, as determined by a clinician's diagnostic evaluation and confirmed by interview using the Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)
  • A current depressive episode that has lasted a minimum of 4 weeks.
  • Have \> 3 trials of antidepressants/augmentation strategies.
  • Have a support system capable of transporting the patient post-treatment.

You may not qualify if:

  • Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
  • Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation Center for Behavioral Health

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepressive Disorder, MajorDepression

Interventions

KetamineMidazolam

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
MURAT ALTINAY, MD
Organization
CLEVELAND CLINIC FOUNDATION
altinam@ccf.org
2164453359

Study Officials

  • Murat Altinay, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff

Study Record Dates

First Submitted

August 7, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

August 29, 2019

Results First Posted

August 29, 2019

Record last verified: 2019-08

Locations

US(1)