Examining The Effect Of Ketamine On... — Clinical Trial Details

Randomised status: non-randomised, crossover design for mechanistic/basic-science purposes; 36 actual participants including healthy controls and participants with MDD receiving ketamine during magnetic resonance scans.

Primary outcomes assess ketamine effects on glutamate/glutamine cycling using 13C‑MRS alongside behavioural measures (MADRS, QIDS-SR16) and safety screening; exclusion criteria include active substance dependence, serious medical/neurological illness, pregnancy, and significant suicidality.

Participants

Ages

21 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Healthy Group
Inclusion Criteria:
Male or female between the ages of 21-65 years.
Able to provide written informed consent.
Able to read and write English.
Depression Group
Inclusion Criteria:
Male or female between the ages of 21-65 years.
Able to provide written informed consent.
Current MDD Single Episode (296.2x) or Recurrent (296.3x), as determined by the Structured Clinical Interview for DSM-IV (SCID) patient edition.
Montgomery-Åsberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of first 13C-MRS.
Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR16) score of 19 or higher at baseline and start of first 13C-MRS.
No psychotropic medications for 2 or more weeks (4 weeks for fluoxetine) prior to first 13C-MRS.
Be able to understand and speak English.

Exclusion Criteria

Healthy Group - Exclusion Criteria:
Personal or first-degree family member with history of mood, anxiety, or psychotic axis I DSM-IV disorders confirmed after comprehensive psychiatric evaluation.
Any history of serious medical or neurological illness.
Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory studies.
Lifetime history of psychoactive substance or alcohol dependence or substance or alcohol abuse (other than nicotine or caffeine), or drinking more than 5 drinks/week during the last year.
Abnormality on physical examination.
A positive pre-study (screening) urine drug screen or, at the study physician's discretion on any drug screens given before the scans.
Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day.
Subjects who test positive for HIV or viral hepatitis (hepatitis B and/or C).
Has received either prescribed or over-the-counter centrally active medicine or herbal supplements within the week prior to the MRI scan.
Any history indicating learning disability, mental retardation, or attention deficit disorder.
Known sensitivity to ketamine.
Body circumference of 52 inches or greater.
Body weight of 280 pounds or greater.
History of claustrophobia.
Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI screening questionnaire.
Donation of blood in excess of 500 mL within 56 days prior to dosing.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Resting blood pressure lower than 90/60 or higher than 150/90, or resting heart rate lower than 45/min or higher than 100/min.
Depression Group - Exclusion Criteria:
Patients with a history of DSM-IV-TR diagnosis of bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
First-degree family member with history of schizophrenia or any other psychotic disorder.
Serious suicide or homicide risk, as assessed by evaluating clinician (see suicidalityDetails).
Substance abuse or dependence during the 12 months prior to screening.
Any history of serious medical or neurological illness.
Any signs of major medical or neurological illness.
Abnormality on physical examination. A subject with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
A positive pre-study (screening) urine drug screen or on any drug screens given before the scans.

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Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Healthy

Interventions

Depressed

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators