Effects of single intravenous arketamine dose as adjunctive therapy for bipolar depression: a randomized, double-blind, crossover, placebo-controlled trial
- Conditions
- Bipolar depression
- Registration Number
- JPRN-UMIN000042201
- Lead Sponsor
- Federal University of Bahia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
RCT exclusion criteria: Current or past diagnosis of Schizophrenia or any other psychotic disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition; subjects with a history of substance abuse disorder, according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition, within the previous 3 months; female subjects who are either pregnant or breastfeeding; serious, unstable medical illnesses; history of seizures without a clear and resolved etiology; treatment with a monoamine oxidase inhibitors within the 4 weeks prior to study; treatment with any other concomitant medication that has been disallowed; presence of any medical illness likely to alter brain morphology and/or physiology; clinically significant abnormal laboratory tests; intellectual disabilities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be a change in the overall MADRS score from day 1 (baseline) to day 2 (24 hours after the infusion).
- Secondary Outcome Measures
Name Time Method