This open-label trial (n=60) tests the hypothesis that ketamine (35mg/70kg) infusion will be especially effective in those who have a family history of alcohol abuse (Family History Positive, FHP).
The trial will test this by administrating ketamine and also alcohol and measuring (f)MRI data in the participants (of which half have an FHP).
Some more data from the trail description about the design and outcome measures:
“This study is a two-site, open-label protocol in psychotropic medication-free depressed subjects. This protocol consists of two phases. Phase I consists of a medication taper (if needed) and at least two week drug-free period. Phase II has three subphases: Subphase IIA (alcohol clamp infusion #1 with neurophysiological assessments), Subphase IIB (alcohol clamp infusion #2 during 7T-MRI) and Subphase IIC (subanesthetic/antidepressant dose ketamine infusion during 7T-MRI).”
“The primary hypothesis/outcome measure will be the mean change in MADRS total score from the pre-ketamine infusion (baseline) to 7 days post-infusion between the FHP and FHN groups. Other exploratory measures include neurophysiological responses to intravenous alcohol, glutamate) alterations during intravenous alcohol infusion and ketamine infusions, and rs-fMRI as a function of family history status.“
Trial Details
Trial Number
Sponsors & Collaborators
National Institute of Mental HealthThis company doesn't have a full profile yet, it is linked to a clinical trial.
University of Iowa
The Niciu Lab at the University of Iowa is interested in the therapeutic effects of ketamine.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.
Beck Depression Inventory
The Beck Depression Inventory (BDI) contains 21 self-report items, completed using a multiple-choice format. Scores range from 0-63 with higher scores associated with more severe depression.
Columbia-Suicide Severity Rating Scale
The Columbia-Suicide Severity Rating Scale (CSSRS) is a suicidal ideation and behaviour rating scale created by researchers at Columbia University, University of Pennsylvania, University of Pittsburgh and New York University to evaluate suicide risk
Clinical-Administered Dissociative Symptoms Scale
The Clinical-Administered Dissociative Symptoms Scale (CADSS) is a scale used to measure dissociative states such as those induced by ketamine.
Clinical Global Impression - Improvement Scale
The Clinical Global Impression - Improvement Scale (CGI-I) is a standardized assessment scale for determining the effects of mental health treatment among psychiatric patients.
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HDRS) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluating recovery. The scale consists of 17 items which each item being scoring on a 3 or 5 point scale. The higher the score, the more likely a person is depressed.