Bipolar Disorder Clinical Trial
Official title:
Ketamine vs. Midazolam in Bipolar Depression
Verified date | February 2020 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | October 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
INCLUSION CRITERIA: - Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation. - Moderate to severe suicidal ideation - 18-65 years old - Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment. - Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills - Able to provide informed consent - Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening EXCLUSION CRITERIA: - Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness - Significant ECG abnormality - Pregnancy and/or lactation - Current psychotic symptoms - Contraindication to any study treatment - Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal - Inadequate understanding of English - Prior ineffective trial of or adverse reaction to ketamine or midazolam - Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University/New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | Brain & Behavior Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation | Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control). | At 24 hours post-Infusion | |
Secondary | Change in Systolic Blood Pressure | Blood pressure is measured in millimeters of mercury. | During study infusion |
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