Clinical TrialMajor Depressive Disorder (MDD)PlaceboKetamineWithdrawn

Ketamine Use in Electroconvulsive Therapy

Randomised, double-blind, parallel study comparing brief pulse ECT with ketamine infusion (0.5 mg/kg) versus ECT with saline in patients with major depression to assess clinical response and cognitive side effects.

Target Enrollment
Not specified
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group trial comparing brief pulse ECT plus ketamine infusion (0.5 mg/kg) versus ECT plus saline placebo on depressive symptoms.

Secondary outcomes include cognitive impairment, quality of life, BDNF levels and associations with 25-hydroxyvitamin D.

Study Arms & Interventions

ECT + saline

inactive

Brief pulse ECT with saline placebo infusion in each session.

Interventions

  • Placebo
    via IV• each session

    Saline infusion in each ECT session.

ECT + Ketamine

experimental

Brief pulse ECT with ketamine infusion in each session.

Interventions

  • Ketamine0.5 mg/kg
    via IV• each session

    Ketamine infusion (0.5 mg/kg) in each ECT session.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria:
  • Patients with unipolar and bipolar depression at the Psychiatric Unit of Hospital de Clinicas de Porto Alegre (diagnosis established by the Structured Clinical Interview for DSM-IV Axis I).

Exclusion Criteria

  • Exclusion criteria:
  • Patients with dementia
  • History of addiction or abuse of psychoactive drugs
  • Other psychiatric diagnoses
  • Refusal to follow the study.

Study Details

Locations

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

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