Clinical trial NCT02012335: Ketamine Use in Electroconvulsive Therapy
Official title: Ketamine Use in Electroconvulsive Therapy: Clinical, Cognitives and Neurotrophic Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D) 17 change
timeFrame: Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks
Secondary outcomes:
measure: Mini Mental Status Exam change
timeFrame: Baseline and at the end of hospital stay, an expected average of 5 weeks
measure: Autobiographical Memory Test change
timeFrame: Baseline and at the end of hospital stay, an expected average of 5 weeks
measure: Rey Auditory Verbal Learning Test change
timeFrame: Baseline and at the end of hospital stay, an expected average of 5 weeks
measure: WAIS Digit Span change
timeFrame: Baseline and at the end of hospital stay, an expected average of 5 weeks
measure: FAS verbal fluency change
timeFrame: Baseline and at the end of hospital stay, an expected average of 5 weeks
measure: Stroop Test change
timeFrame: Baseline and at the end of hospital stay, an expected average of 5 weeks
measure: Trial Making Test change
timeFrame: Baseline and at the end of hospital stay, an expected average of 5 weeks
measure: WAIS Vocabulary
timeFrame: Baseline
measure: Montgomery and Asberg Depression Rating Scale change
timeFrame: Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks
measure: Brief Psychiatry Rating Scale change
timeFrame: Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks
measure: Clinical Global Impression-Severity change
timeFrame: Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
state: RS
Study officials:
References: