Ketamine Use in Electroconvulsive Therapy

Depression Clinical Trial

Official title:

Ketamine Use in Electroconvulsive Therapy: Clinical, Cognitives and Neurotrophic Outcomes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02012335
• Other study ID #: 13-0196
• Status: Withdrawn
• Phase: N/A
• First received: November 18, 2013
• Last updated: March 18, 2015
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• ECT + Ketamine
Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Mini Mental Status Exam change		Baseline and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	Autobiographical Memory Test change		Baseline and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	Rey Auditory Verbal Learning Test change		Baseline and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	WAIS Digit Span change		Baseline and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	FAS verbal fluency change		Baseline and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	Stroop Test change		Baseline and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	Trial Making Test change		Baseline and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	WAIS Vocabulary		Baseline	Yes
Secondary	Montgomery and Asberg Depression Rating Scale change		Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	Brief Psychiatry Rating Scale change		Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks	Yes
Secondary	Clinical Global Impression-Severity change		Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks	Yes