Ketamine Use in Electroconvulsive Therapy

Ketamine

Brief Summary

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

Intervention / Treatment

  • ECT + Ketamine (DRUG)
    Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session

Condition or Disease

  • Depression

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Jan 01, 2014
    Primary Completion: Jan 01, 2016 ESTIMATED
    Completion Date: Jan 01, 2016 ESTIMATED
    Study First Posted: Dec 16, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 18, 2015

    Sponsors / Collaborators

    Lead Sponsor: Hospital de Clinicas de Porto Alegre
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Porto Alegre, Brazil
    Rio Grande do Sul, Brazil

    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.

    Participant Groups

    • Brief pulse ECT with saline as placebo in each session

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • 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
    • 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
    • Rey Auditory Verbal Learning Test change Baseline and at the end of hospital stay, an expected average of 5 weeks
    • WAIS Digit Span change Baseline and at the end of hospital stay, an expected average of 5 weeks
    • FAS verbal fluency change Baseline and at the end of hospital stay, an expected average of 5 weeks
    • Stroop Test change Baseline and at the end of hospital stay, an expected average of 5 weeks
    • Trial Making Test change Baseline and at the end of hospital stay, an expected average of 5 weeks
    • WAIS Vocabulary Baseline
    • 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
    • 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
    • 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

    More Details

    NCT Number: NCT02012335
    Other IDs: 13-0196
    Study URL: https://clinicaltrials.gov/study/NCT02012335
    Last updated: Sep 29, 2023