NCT01260649.

Study name	N‐methyl‐D‐aspartate antagonist (ketamine) augmentation of electroconvulsive treatment for severe major depression
Methods	Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: double‐blind (participant, investigator) Primary purpose: treatment
Participants	Inclusion criteria Nales and females between the ages of 18 to 65 years 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, Generalised anxiety, panic disorder) will be allowed as long as the clinician administering the SCID believes that they are not the primary diagnosis Exclusion criteria 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 anaesthesia 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
Interventions	Ketamine versus placebo
Outcomes	Primary outcome measures: HRSD‐28. Time frame: one month. [ Designated as safety issue: No]. HRSD will be administered at every ECT treatment, and 7‐10 days after last ECT (approximately 1 month after baseline)
Starting date	November 2010
Contact information	mailto:ccusin%40partners.org?subject=NCT01260649, 2010P001672, N‐methyl‐D‐aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression
Notes	NCT01260649