Depression
Conditions
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.
Interventions
DRUGECT + Ketamine
Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Mini Mental Status Exam 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 |
| Trial Making Test change | Baseline and at the end of hospital stay, an expected average of 5 weeks |
Countries
Brazil
Outcome results
None listed