Status:
TERMINATED
N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 co...
Detailed Description
Aim #1: To assess the efficacy of ketamine augmentation in reducing time to remission of a major depressive episode (MDE). Aim #2: To assess the efficacy of ketamine augmentation on ECT-related cogni...
Eligibility Criteria
Inclusion
- males and females between the ages of 18-65,
- DSM-IV diagnosis of Major Depressive Disorder (MDD), without psychotic features
- HAM-D-28 score of 20 or higher
- 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
- MDD with a score of \<20 on the HAM-D 28,
- Other DSM-IV primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia
- any history of psychosis
- substance use disorder (abuse or dependence with active use within the last 6 months), and any lifetime history of ketamine abuse or dependence;
- organic mental disorders;
- seizure disorder or chronic antiepileptic medications;
- 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)
- current treatment with memantine
- pregnancy, or females of reproductive age who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods).
- known hypersensitivity to ketamine
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01260649
Start Date
November 1 2010
End Date
November 1 2012
Last Update
May 22 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114