Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression
Condition: Unipolar Depression; Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Ketamine; Methohexital
Intervention description: Ketamine 1-2 mgr/ kg IV; Methohexital 0.5-1mg/kg IV
Intervention MeSH terms: Ketamine; Methohexital
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Electroconvulsive Therapy; Ketamine; anesthesia; depression; unipolar; bipolar

Summary:

      The study aims to compare outcomes of Electroconvulsive Therapy (ECT) using ketamine versus
      methohexital anesthesia in depressed patients. The investigators hypothesize that patients
      who receive ketamine anesthesia during ECT will achieve remission status faster than those
      receiving methohexital anesthesia. Also, at the end of the ECT course subjects will display
      fewer cognitive side effects compared to those treated with methohexital anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects 18 to 70 years of age

          2. Diagnostic Statistical Manual (DSM) IV diagnosis of Major Depression (296.3), unipolar
             without psychotic features or Bipolar I or Bipolar II Depression without psychotic
             features confirmed by Structured Clinical Interview for DSM-IV (SCID-IV) interview

          3. Pretreatment 24-item Hamilton Rating Scale for Depression score > 21

          4. Subjects must have an initial score of at least 20 on the Montgomery-Asbergers
             Depression Rating Scale (MADRS) at screen

          5. ECT is clinically indicated

          6. Patient is competent to provide informed consent

        Exclusion Criteria:

          1. Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder, psychotic
             depression or any other psychotic disorder as defined in the DSM-IV

          2. Current (within the last year) diagnosis of anxiety disorder, obsessive- compulsive
             disorder, or eating disorder that precedes the onset of the current episode of
             depression

          3. Current diagnosis of delirium, dementia, or amnestic amnesiac disorder

          4. Diagnosis of Mental Retardation

          5. Baseline Mini Mental State Exam (MMSE) score < 21 or a total score falling two
             standard deviations below the age- and education-adjusted mean, whichever is less

          6. Any active general medical condition or central nervous system (CNS) disease which can
             affect cognition or response to treatment

          7. Current (within the past three months) diagnosis of active substance dependence, or
             active substance abuse within the past week

          8. Lifetime history of ketamine or phencyclidine (PCP) abuse or dependence

          9. ECT within three months

         10. The presence of any known or suspected contraindication to methohexital or ketamine
             including but not limited to known allergic reactions to these agents, uncontrolled
             hypertension, arrhythmia, severe coronary artery disease and porphyria

         11. Pregnancy

         12. Status 4 or greater according to the criteria of the American Society of
             Anesthesiologists

         13. MRI contraindications