Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up to 6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the longer term effects of ketamine.
Topic Depression
Compound Ketamine
Country United States of America
Visit trial
Status
Unknown status
Results Published
Start date
31 January 2017
End date
30 June 2021
Chance of happening
100%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
11
Sex
All
Age
21- 75
Therapy
No
Trial Details
A total of 25 depressed subjects between the ages of 21-75 who have current major depressive disorder without psychotic features by DSM-5 will be recruited. Subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments. Patients will be recruited in outpatient settings to the Refractory Depression Clinic. Providers or Refractory Depression consult team will be informed if the patient may be eligible for participation in the ketamine protocol. Subjects must have established care in the VA Connecticut Healthcare System. If the Veteran is interested, a screening visit for further evaluation for the ketamine protocol will be scheduled. Veterans will receive up to 6 infusions for ketamine weekly, per PI discretion. The primary goal of this proposal is to test the effectiveness of repeated ketamine treatment (0.5 mg/kg; once or twice a week for up to 6 weeks; up to a total of 6 ketamine infusions). An open-label trial will be conducted that will include up to 25 Veterans with MDD with a follow-up of 6 months. This open-label trial will allow us to examine the safety and tolerability of the ketamine treatment in this population and the long-term effects. All patients will receive usual standard care during this trial.NCT Number NCT03053830
Sponsors & Collaborators
Loma Linda UniversityThis company doesn't have a full profile yet, it is linked to a clinical trial.
MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.
Quick Inventory of Depressive Symptomatology
The Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16) is a self-report tool designed to screen for depression and measure changes in the severity of symptoms.
Clinical-Administered Dissociative Symptoms Scale
The Clinical-Administered Dissociative Symptoms Scale (CADSS) is a scale used to measure dissociative states such as those induced by ketamine.
Columbia-Suicide Severity Rating Scale
The Columbia-Suicide Severity Rating Scale (CSSRS) is a suicidal ideation and behaviour rating scale created by researchers at Columbia University, University of Pennsylvania, University of Pittsburgh and New York University to evaluate suicide risk
Clinical Impairment Assessment Questionnaire
The Clinical Impairment Assessment Questionnaire (CIA) is a brief self-report measure that is designed to be given immediately after the EDE-Q. It provides a continuous measure of the severity of impairment associated with an eating disorder (ED).