Depression
Conditions
Interventions
Trade Name: Ketalar
Product Name: Ketalar 10mg/ml Solution for injection
Product Code: N01AX03
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: ketamine hydrochloride
CAS Numb
Sponsors
St Patrick's Mental Health Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • =18 years old • Able to provide informed consent • Voluntary admission for treatment of an acute depressive episode • Meet DSM-V criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression) • Montgomery Asberg Depression Rating Scale 10 item version (MADRS) score of =20 • Referred for treatment with ECT • Sufficiently physically healthy to receive ketamine/midazolam and ECT Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: • Inability to provide informed consent • Current involuntary admission • History of Axis 1 diagnosis other than major depression • Medical condition rendering unfit for ketamine/midazolam or ECT • Active suicidal intention • Presence of major neurological or organic brain disorder • Alcohol/substance dependence in previous six-months • Pregnancy or inability to confirm use of adequate contraception during the trial • Breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To conduct a randomised controlled patient- and rater-blinded pilot trial of twice weekly ketamine vs. midazolam as an adjunctive therapy interleaved with ECT in the treatment of a major depressive episode. Assess feasibility of a future definitive trial.;Secondary Objective: To assess safety and tolerability of repeated twice-weekly infusions of ketamine vs. midazolam in this depressed population. ;Primary end point(s): This pilot trial is not designed to assess efficacy. Rather, a 95% confidence interval for the difference between MADRS scores between ketamine and midazolam groups, at various timepoints, will be obtained, to inform a future definitive trial. We will measure these MADRS scores at baseline, during after infusions, one week after the final infusion and at 6 and 12 weeks post final infusion. ;Timepoint(s) of evaluation of this end point: The primary endpoint of this polit trial is successful completion of the trial protocol. Process outcomes such as recruitment and retention rates are the primary focus. Recruitment will cease once 24 participants have been randomised. We will measure these MADRS scores at baseline, during after infusions, one week after the final infusion and at 6 and 12 weeks post final infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical outcomes are secondary. The primary clinical outcome is a decrease in depressive symptoms, measured using the objectively-rated 10-item Montgomery Asberg Rating Scale (MADRS). Standard criteria for depression severity, treatment response, remission and relapse will be used (please see definitions in “assessments”) in a three-month follow-up schedule which involves the MADRS and other instruments at weeks 6 and 12 post final infusion. Safety and tolerability outcomes consist of psychotomimetic, dissociative, cognitive and physical health effects of repeated ketamine infusions, measured before, during and after infusions using a range of validated instruments. ;Timepoint(s) of evaluation of this end point: Standard criteria for depression severity, treatment response, remission and relapse will be used in a three-month follow-up schedule which involves the MADRS and other instruments at weeks 6 and 12 post final infusion | — |
Countries
Ireland
Contacts
Public ContactDr Eimear Doody
St Patrick's Mental Health Services
Outcome results
None listed