Intravenous Ketamine for Treatment-Resistant Depression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMayo Clinic
About this trial
The purpose of this study is to to evaluate the relationships between peak (% change from baseline) central GABA and Glu levels during a 40-min IV ketamine or normal saline infusion utilizing fMRS, and change in peripheral GABA and Glu levels from baseline to 24-hr postinfusion utilizing LCMS, with baseline to 24-hr post-infusion change in depression (MADRS) in 30 TRD adults.
Eligibility criteria
Qualifiers
Ability to provide informed consent
Meets diagnostic criteria for major depressive disorder without psychotic features per the SCID DSM-IV-TR
PHQ-9 total score ≥ 15 at screening
Treatment-resistant depression, as defined by failure of at least two previous antidepressant treatments within the current depressive episode. Failed antidepressant treatments can include pharmacotherapy for depression at an adequate dose for at least 8 weeks, trial of transcranial magnetic stimulation (TMS) or an acute series of at least 6 administrations of electroconvulsive therapy (ECT)
Disqualifiers
Inability to speak English
Inability to provide consent or have a legal guardian
Patients with a BMI > 40 kg/m2.
Personality disorder being the primary diagnosis
Trial design
Treatments tested in this trial
- Ketamine
- Normal Saline
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov