Status:
COMPLETED
Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Unipolar Depression
Bipolar Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ketam...
Detailed Description
Despite major advances in the treatment of mood disorders, depression remains a serious public health problem. Delayed onset of response and lack of efficacy in a significant portion of patients are t...
Eligibility Criteria
Inclusion
- Male or female subjects 18 to 70 years of age
- 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
- Pretreatment 24-item Hamilton Rating Scale for Depression score \> 21
- Subjects must have an initial score of at least 20 on the Montgomery-Asbergers Depression Rating Scale (MADRS) at screen
- ECT is clinically indicated
- Patient is competent to provide informed consent
Exclusion
- Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the DSM-IV
- 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
- Current diagnosis of delirium, dementia, or amnestic amnesiac disorder
- Diagnosis of Mental Retardation
- 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
- Any active general medical condition or central nervous system (CNS) disease which can affect cognition or response to treatment
- Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
- Lifetime history of ketamine or phencyclidine (PCP) abuse or dependence
- ECT within three months
- 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
- Pregnancy
- Status 4 or greater according to the criteria of the American Society of Anesthesiologists
- MRI contraindications
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01881763
Start Date
June 1 2010
End Date
July 1 2017
Last Update
March 9 2023
Active Locations (1)
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1
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004