Ketamine Use in Electroconvulsive Therapy

Hospital de Clinicas de Porto Alegre

Status: Withdrawn

Conditions: Depression

Treatments: Drug: ECT + Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02012335

13-0196

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

ECT + saline

Placebo Comparator group

Description:

Brief pulse ECT with saline as placebo in each session

ECT + Ketamine

Experimental group

Description:

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

Treatment:

Drug: ECT + Ketamine