Bipolar Disorder Clinical Trial
Official title:
Ketamine vs. Midazolam in Bipolar Depression
This study is designed to compare the effectiveness of two medications, Ketamine and
Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar
depression.
The first drug, ketamine, is an experimental antidepressant that early studies have shown may
quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the
comparison drug, is not thought to reduce depression or suicidal thoughts.
Patients currently taking psychiatric medications may continue them during the study.
However, if a patient is taking a benzodiazepine (such as Ativan, Klonopin, or Xanax), they
will be able to take up to 2mg per day of Lorazepam during the week before the infusion, but
none will be permitted in the 24 hours pre-infusion. Also, Zolpidem (Ambien) will not be
permitted in the 24 hours pre-infusion. If a person chooses to participate, their dose of
benzodiazepine may need to be reduced so that they can do without it during the 24 hours
pre-infusion.
Participants are randomly assigned to receive a single dose of Ketamine (0.5 mg/kg) or
Midazolam (0.02 mg/kg), which is given slowly, in a vein, over about 40 minutes. The study is
"double-blind," meaning patients and study staff will not know which medication is in the
infusion.
If a patient does not respond to the first infusion, and s/he received Midazolam, then s/he
will be offered the option of a second infusion, this time with Ketamine (0.5 mg/kg). After
the infusion(s), participants will have weekly research interviews for 6 weeks to monitor
response.
After post-infusion research measures are completed, all subjects will receive open clinical
treatment. During open clinical treatment, medication will be changed for those patients who
don't respond or whose response is transient.
Participation in this study requires a brief inpatient stay, at no cost, at the New York
State Psychiatric Institute (NYSPI).
Eligible participants enrolled in this study will be offered medication management visits at
no cost for a total of up to 6 months combining inpatient and outpatient treatment. At the
end of the 6 months of treatment patients will be referred for ongoing care.
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