December 2021
Volunteers with Parkinson's Disease and Depression, Aged 40-70, are needed!
 Volunteers with Parkinson’s disease and depression aged between 40-70 are needed to take part in a groundbreaking clinical trial examining ketamine as a new antidepressant in Parkinson’s disease. The trial will involve receiving either ketamine or placebo twice per week for 3 weeks. You will also have the option to take part in brain imaging before and after the treatment. Taking part in this trial could help with the discovery of important new treatments for depression in Parkinson’s disease. You will be reimbursed up to $2000 for your time.
For more information, please email ketaminepd@yale.edu
or call/text (475) 287-9521.
Ketamine for the Treatment of Depression in Parkinson’s Disease (KET-PD)
HIC #: 2000030394
PIs: Dr. Sophie Holmes, PhD; Dr. Gerard Sanacora, MD, PhD; and Dr. Sina Nikayin, MD
 
As we are sure you are aware, depression affects around half of people with Parkinson’s disease (PD). Traditional antidepressants show limited efficacy. Case reports have shown evidence of ketamine alleviating depression and the side effects of Parkinson’s medications (L-DOPA)
We will conduct the first randomized, placebo-controlled, double-blind clinical trial to assess the antidepressant effects of ketamine in PD.
§ n = 56 patients with PD and depression
§ Randomized to receive 6 infusions of either ketamine (0.5 mg/kg) or placebo (saline)
§ Administered 2x/week for 3 weeks
§ Primary outcome: change in Montgomery Asberg Depression Rating Scale (MADRS)
§ Exploratory aims: assess ketamine’s effects on apathy, anxiety, anhedonia, PD symptoms, dyskinesia, pain, and fatigue (using self-report/clinician administered questionnaires)

Key Inclusion Criteria:
§ Male or female ages 40-70 years, inclusive.
§ Clinical diagnosis of Parkinson’s disease, stage 1, 2 or 3 as determined by the Hoehn and Yahr Scale
§ Meet criteria for major depressive disorder (MDD) – (by the MINI and a score of 15 or greater on MADRS)
§ For women of reproductive potential, use of contraception 1 month prior to screening and during study
§ Abstinence from drugs of abuse, other than alcohol, cannabis, nicotine, and caffeine
Key Exclusion Criteria:
§ Presence of dementia (Montreal Cognitive Assessment (MoCA) < 21)
§ A significant psychiatric disorder except for MDD
§ Active suicidal ideation with intent
§ History of substance dependence and/or current substance use disorder (excluding tobacco use)
§ Abstinence from drugs of abuse, other than alcohol, cannabis, nicotine, and caffeine
§ Prior participation in a ketamine study, prior clinical psychiatric treatment with ketamine, or prior recreational use of ketamine.

Contact us:
Phone: 475 287 9521