Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
Brief Summary: Research into the mechanisms underlying memory impairment in ECT suggests that its development may be prevented by the administration of certain medications at the time of ECT treatment. For example there are reasons to believe that ketamine, also used as an anaesthetic agent, may have such protective properties.

In this clinical study patients undergoing a course of ECT will be offered the opportunity to receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects who received ketamine had less memory side effects than those who did not, while still improving their depression.


Options:
A: Inclusion Criteria:

* Satisfy DSM-IV-TR criteria for Major Depressive Episode
* 18 years or over
* Does not have a diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
* No known sensitivity to ketamine
* No ECT in the last 3 months
* No drug or alcohol abuse in the last 12 months
* Able to give informed consent
* Score at least 24 on Mini Mental State Examination
B: INCLUSION CRITERIA:

1. Male or female (not of reproductive potential, unable to conceive) subjects, 18 to 55 years of age. A female patient not of reproductive potential is defined as one who: a) has reached menopause with: i) no menses for the past 3 or more years OR ii) no menses for greater than 1 year but less than 3 years with confirmation of FSH levels elevated into the postmenopausal range; or b) has undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
3. Subjects must fulfill DSM-IV criteria for Major Depression (296.3) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P.
4. Subjects must have an initial score of at least 22 on the MADRS at screen and at baseline of study phase II.
5. Current or past history of lack of response to two adequate antidepressant trials (may be from the same chemical class) operationally defined using the Antidepressant Treatment History Form (ATHF). If subjects have only failed to respond to one adequate antidepressant trial by history, they will be permitted to receive a prospective trial of a standard antidepressant. Subjects who fail to respond to this prospective trial will meet criteria for treatment-resistance and be eligible to randomize. Subjects responding to the prospective trial will be ineligible to randomize. (A CORE representative will be present when the subject is informed as to the decision to randomize or not).
6. Current major depressive episode of at least 4 weeks duration.

EXCLUSION CRITERIA:

1. Current or past history of bipolar disorder, psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
2. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (including for nicotine and caffeine) within the preceding 3 months.
3. Subjects with a diagnosis of Obsessive Compulsive Disorder or Posttraumatic Stress Disorder as defined in the DSM-IV.
4. Subjects with a diagnosis of Borderline or Antisocial Personality disorder. Other Axis II disorders do not qualify one for exclusion from the study.
5. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
6. Patient has a history of any cardiovascular disease, including myocardial infarction, cardiac arrhythmias or conduction abnormalities, cerebrovascular accident, transient ischemic attack (TIA), or peripheral vascular disease.
7. Patient has systolic blood pressure of less than 90 mm Hg or greater than 135 mm Hg at the screen visit or has orthostatic hypotension at the screen visit (greater than or equal to 20 mm Hg decline in systolic blood pressure compared with previous supine systolic blood pressure plus orthostatic symptoms within 3 minutes after standing).
8. Clinically significant abnormal laboratory test or electrocardiogram.
9. Subjects with uncorrected hypothyroidism or hyperthyroidism.
10. Subjects with one or more seizures without a clear and resolved etiology.
11. Previous lack of antidepressant response to ketamine or hypersensitivity to ketamine or amantadine.
12. Treatment with fluoxetine within 5 weeks prior to study phase I.
13. Treatment with any other concomitant medication not allowed 7 days (14 days for MAOIs) prior to study phase II.
14. Treatment with clozapine or ECT within 2 months prior to study phase II.
15. MADRS greater than 4 on item 10 (suicidal ideation).

No structured psychotherapy will be permitted during the study.
C: Inclusion Criteria:

1. Male or female patients, 21-80 years of age;
2. Female individuals who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or using a medically accepted reliable means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative serum beta-human growth hormone at screening and at pre-infusion;
3. Participants must fulfill DSM-IV criteria for Major Depression without psychotic features, based on clinical assessment by a study psychiatrist and confirmed by a structured diagnostic interview, the Structured Clinical Interview for DSM-IV TR Axis I Disorders, Patient Edition (SCID-P);
4. Participants must have a history of at least one previous episode of depression prior to the current episode (recurrent MDD) or have chronic MDD (of at least two years' duration);
5. Participants have not responded to three or more adequate trials of an antidepressant as determined by Antidepressant Treatment History Form (ATHF) criteria (score \>=3);
6. Participant scores on the IDS-C30 must be greater than or equal to 32 at both Screening and within 24 hours prior to Visit 1a (Phase 1);
7. Current major depressive episode is of at least 4 weeks duration.
8. Each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
9. Each participant must be able to identify a family member, physician, or friend who will participate in the Treatment Contract.

Exclusion Criteria:

1. Lifetime history of psychotic features, diagnosis of schizophrenia or any other psychotic disorder, or diagnosis of bipolar disorder
2. Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
3. Current diagnosis of Obsessive Compulsive Disorder or eating disorder (bulimia nervosa or anorexia nervosa);
4. Subjects with DSM-IV drug or alcohol abuse/dependence within the preceding 2 years;
5. Patients with schizotypal or antisocial personality disorder, or any clinically significant axis II disorder that would, in the investigator's judgment, preclude safe study participation;
6. Patients judged clinically to be at serious and imminent suicidal or homicidal risk;
7. Women who are either pregnant or nursing;
8. Serious, unstable medical illnesses including hepatic, renal, gastroenterologic (including gastroesophageal reflux disease), respiratory (including obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics), cardiovascular (including ischemic heart disease and uncontrolled hypertension), endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
9. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
10. Patients with one or more seizures without a clear and resolved etiology;
11. Patients starting hormonal treatment (e.g., estrogen) in the last 3 months prior to Visit 1a;
12. Treatment with an irreversible MAOI or any other FDA approved Anti depressant medication within one week prior to Visit 1a (with the exception of a stable dose of non-benzodiazepines hypnotics i.e. zolpidem, eszopiclone, etc for at least 3 months);
13. Treatment with fluoxetine within 4 weeks prior to Visit 1a;
14. Evidence-based individual psychotherapy (e.g. CBT or IPT) and other non-pharmacological antidepressant treatments (e.g. light therapy) will not be permitted during the acute study period (7 day);
15. Previous recreational use of PCP or Ketamine.
16. Past intolerance or hypersensitivity to midazolam
17. Hypertension (systolic BP \>160 mm Hg or diastolic BP \>90 mm Hg) not controlled by diuretic or beta-blocker therapy alone or in combination.
18. Evidence of age-related cognitive decline or mild dementia suggested by a score of \< 27 on the Mini-Mental State Examination (MMSE) at Screening
D: Inclusion Criteria:

* diagnosis of major depressive disorder consistent with DSM-IV-TR
* current episode greater than 8 weeks in duration
* Hamilton Depression score \>/- 21
* less than 25% reduction in depression during current episode assessed by ATRQ

Exclusion Criteria:

* Axis diagnosis of other psychiatric disorders
* Experiencing hallucinations, delusions, other psychotic symptomatology
* ECT during current episode

Answer: A