Bipolar depression
Conditions
Interventions
A pilot study will be conducted with patients with bipolar depression at the doses of 0.5mg / kg and 1mg / kg. Afterwards, a randomized, double-blind, crossover, controlled study will be performed.
Sponsors
Federal University of Bahia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: RCT inclusion criteria: Both genders; age between 18 to 65 years; subjects must fulfill Diagnostic and Statistical Manual of Mental Disorders 5th Edition criteria for Depressive Episode of Bipolar Disorder types I and II, without psychotic features; age of disease onset before 40 years old; no current maniac episode; initial score of at least 25 on the Montgomery Asberg Depression Rating Scale at study baseline; subjects must, at some point in their past, have failed to respond to an adequate dose and duration of at least one antidepressant drug during a depressive episode; current depressive episode of at least 4 weeks duration; participants should take valproic acid or lithium at therapeutic doses (20mg / kg for valproic acid and 0.6-1.2 mEq / L for lithium) for at least 4 weeks prior to intervention.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be a change in the overall MADRS score from day 1 (baseline) to day 2 (24 hours after the infusion). | — |
Countries
South America
Contacts
Public ContactLucas Quarantini
Federal University of Bahia Laboratory of Neuropsychopharmacology
Outcome results
None listed