Major Depression Clinical Trial
Official title:
Ketamine Anesthesia to Enhance Efficacy and Tolerability of Electroconvulsive Therapy in Patients With Unipolar or Bipolar Depression
The primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects.
Electroconvulsive therapy (ECT) is one of the most robust antidepressant treatments
available. However, there is the potential for significant acute and longer term adverse
cognitive effects with ECT and the antidepressant response requires multiple treatment
sessions, increasing risk of adverse effects. Further, antidepressant response to ECT is
often less than maximal and relapse is common. Growing preclinical and clinical evidence of
the rapid-acting antidepressant properties of the anesthetic agent ketamine suggests the use
of ketamine anesthesia as a strategy to increase rate of response and shorten treatment
course in the administration of ECT. In addition, preclinical and clinical evidence suggests
the potential of ketamine to decrease the adverse cognitive effects associated with ECT.
The investigators propose a pilot study to measure both acute therapeutic efficacy and
cognitive side effects of ECT using ketamine compared to methohexital in depressed patients.
The investigators will also explore other parameters of ECT such as seizure duration and
morphology, as well as hemodynamic and behavioral changes.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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