Ketamine Use in Electroconvulsive Therapy | NCT02012335

Studies
Ketamine Use in Electroconvulsive Therapy

NCT02012335

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Withdrawn

Last Update Posted

Mar 19, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Depression

Interventions

ECT + Ketamine

Countries

Brazil

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Methodologicals and logistics issues.

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Nov 18, 2013

First Submission Date that Met QC Criteria

Dec 9, 2013

First Posted Date

Dec 16, 2013Estimated

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 18, 2015

Last Update Posted Date

Mar 19, 2015Estimated

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

Description Module

Brief Summary

The purpose of this study is to determine whether combination of ketamine plus electroconvulsive therapy improves depressive symptoms decreasing cognitive side effects.

Detailed Description

This study will compare the clinical response to brief pulse ECT with infusion of ketamine 0.5 mg/kg versus brief pulse electroconvulsive therapy with infusion of placebo (saline) in major depression. We also will compare levels of cognitive impairment among these groups, compare levels of quality of life among these groups, compare levels of BDNF among these groups. We also will study if levels of 25-hydroxyvitamin D are associated with cognitive impairment in subjects undergoing ECT.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECT + saline	Placebo Comparator	Brief pulse ECT with saline as placebo in each session
ECT + Ketamine	Experimental	Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session	Drug: ECT + Ketamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECT + Ketamine	Drug	Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session	ECT + Ketamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hamilton Depression Scale (HAM-D) 17 change		Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mini Mental Status Exam change		Baseline and at the end of hospital stay, an expected average of 5 weeks
Autobiographical Memory Test change		Baseline and at the end of hospital stay, an expected average of 5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

- Patients with unipolar and bipolar depression from The Psychiatric Unit of Hospital de Clinicas de Porto Alegre (diagnosis will be established by the Structured Clinical Interview for DSM-IV Axis I)

Exclusion criteria:

Patients with dementia
History of addiction / abuse of psychoactive drugs
Other psychiatric diagnoses
Refusal to follow the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)		Porto Alegre	Rio Grande do Sul	90035-003	Brazil

ID	Term
D003863	Depression

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D004565	Electroconvulsive Therapy
D007649	Ketamine

Ancestor Terms

ID	Term
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies
D004191	Behavioral Disciplines and Activities
D004597	Electroshock

Browse Leaves

Not provided

Browse Branches

Not provided