Ketamine Use in Electroconvulsive Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ECT + saline

Brief pulse ECT with saline as placebo in each session

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

ECT + Ketamine

Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session

Group Type EXPERIMENTAL

ECT + Ketamine

Intervention Type DRUG

Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session

Interventions

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ECT + Ketamine

Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session

Intervention Type DRUG

Eligibility Criteria

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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)