Ketamine Use in Electroconvulsive Therapy

NCT02012335 | Withdrawn

• 1 other identifier: 13-0196
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 (11)

• 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

Study Arms (2)

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

ECT + Ketamine DRUG

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

ECT + Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

MeSH Terms

Conditions

Depression

Interventions

Electroconvulsive Therapy; Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 16, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

BR (1)