N-methyl-D-aspartate Antagonist (Ketamine)... — Clinical Trial Details

Randomized, double-blind, parallel-group Phase IV trial comparing IV ketamine 0.5 mg/kg versus IV saline given before the first three right-unilateral ECT treatments in adults with severe major depressive disorder; primary outcome is time to remission (HAM-D-28).

Secondary aims examine ECT-related cognitive side effects using a neuropsychological battery at baseline, end of acute series and 3-month follow-up; safety and tolerability monitored throughout. Repeated EEG will assess functional connectivity before, during and after ECT.

Planned recruitment was 30 over 24 months; registry record indicates actual count N=17. Conducted at Massachusetts General Hospital, Boston, USA.

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

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N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Study Arms & Interventions

Ketamine + ECT

Interventions

Saline + ECT

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

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