Oral Ketamine vs Active Placebo for Treatment of Major Depressive Disorder: A Randomized Control Trial
Oral ketamine treatments are becoming increasingly available for those who can afford them. There is very limited evidence to support the use of oral ketamine as treatment for Major Depressive Disorder (MDD).
Intranasal esketamine (Spravato) is FDA approved for treatment resistant depression. There is growing evidence that intravenous (IV) ketamine infusions are effective for MDD and Columbia University now offers IV ketamine for treatment of MDD. There are a number of for-profit clinics around the nation advertising oral ketamine as an effective treatment for depression—along with many other psychiatric disorders such as anxiety, substance use disorder, PTSD, OCD and more. These for-profit clinics offer patients expensive treatment programs that cost thousands of dollars out of pocket. However, there is very limited high quality evidence demonstrating the benefits of oral ketamine. It is reasonable to hypothesize that oral ketamine is effective for depression, but evidence of safe and effective dosing is lacking. In this randomized control trial, we will aim to demonstrate the safety, efficacy and tolerability of oral ketamine for MDD.
Randomized, controlled, parallel-group, pilot clinical trial of oral ketamine vs. active placebo (lorazepam) as therapy for Major Depressive Disorder (MDD). The main purpose of the pilot study is to assess the safety, efficacy and tolerability of oral ketamine as treatment for MDD.
Randomized, controlled, parallel-group, pilot trial. Trial participants will be patients recruited by the Redemptive Therapy Institute. The investigators aim to recruit up to 50 participants who will be eligible for this study and randomly allocate 25 patients to each group. Both participants and assessors will be blind to treatment allocation. Consented participants will be randomly allocated in a 1:1 ratio to a four week course of either once-weekly ketamine or active placebo (lorazepam) dosing sessions. Both groups will receive psychotherapy and health coaching before and after each dosing session. Block randomization will be independently performed. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after dosing sessions. Participants will be followed over a six month period.
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