| Study name |
Ketamine versus midazolam in bipolar depression |
| Methods |
Allocation: randomised
Endpoint classification: efficacy study
Intervention Model: parallel assignment
Masking: double‐blind (participant, caregiver, investigator, outcomes assessor) |
| Participants |
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 Particpants 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 Diagnosis of sleep apnoea
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| Interventions |
Ketamine versus midazolam |
| Outcomes |
Primary outcome measures: Reduction of suicidal ideation measured with the Beck Scale for Suicidal Ideation. Time frame: At 24 hours post‐infusion. [Designated as safety issue: No]. Reduction of 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 with ketamine or midazolam, a sedative not known to reduce suicidal ideation |
| Starting date |
September 2013 |
| Contact information |
mailto:marverj%40nyspi.columbia.edu?subject=NCT01944293, #6785, Ketamine for Suicidality in Bipolar Depression |
| Notes |
NCT01944293 |
