N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ketamine; IV Saline; ECT; Muscle Relaxant; Anesthetic Agents
Intervention description: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg) or IV Saline, followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care; eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg) or IV Saline, followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care; ECT will be administered as per standard of care; All participant will receive routine course of muscle relaxant with ECT as per standard of care; All participant will receive routine course of anesthetic agents with ECT as per standard of care
Intervention MeSH terms: Ketamine; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Electroconvulsive treatment; ketamine; Major Depression; Treatment-resistant Major Depressive Disorder

Summary:

      Electroconvulsive therapy (ECT), is considered the most effective treatment for severe
      treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of
      treatments and can cause considerable acute deficits in memory. It would be a major advance
      in treatment if ECT could work faster with fewer treatments and result in decrease incidence
      of memory problems. Ketamine is an excellent candidate for augmentation of ECT because of its
      acute effects on depression, its short half-life, and its safety profile when given at low
      doses. Ketamine is given as an infusion and could easily be incorporated into the routine
      management of patients undergoing ECT, but has never been evaluated prospectively in this
      context.

      The investigators propose to assess the efficacy, feasibility, tolerability and safety of
      N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. males and females between the ages of 18-65,

          2. DSM-IV diagnosis of Major Depressive Disorder (MDD), without psychotic features

          3. HAM-D-28 score of 20 or higher

          4. requiring ECT treatment as part of their psychiatric care Comorbid anxiety disorders
             (OCD, Generalized anxiety, panic disorder) will be allowed as long as the clinician
             administering the SCID believes that they are not the primary diagnosis.

        Exclusion Criteria:

          1. MDD with a score of <20 on the HAM-D 28,

          2. Other DSM-IV primary diagnoses including major depressive disorder with psychotic
             features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia

          3. any history of psychosis

          4. substance use disorder (abuse or dependence with active use within the last 6 months),
             and any lifetime history of ketamine abuse or dependence;

          5. organic mental disorders;

          6. seizure disorder or chronic antiepileptic medications;

          7. severe or unstable medical illness, including history of closed head injury resulting
             in loss of consciousness, medical contraindication to anesthesia or to ECT (i.e.
             recent myocardial infarction, increased intracranial pressure)

          8. current treatment with memantine

          9. pregnancy, or females of reproductive age who are not using an accepted method of
             contraception (birth control pill, IUD, combination of barrier methods).

         10. known hypersensitivity to ketamine