Post-stroke Depression
Conditions
Brief summary
Studies have shown that ketamine is very effective and has a quick onset in treatment of depression. Most of these studies used intravenous ketamine in an inpatient setting and there are no large trials examining its use in Post Stroke Depression (PSD). There have been only few studies that have used other routes of administration (i.e., oral, transmucosal, intranasal, intramuscular) of ketamine which provided symptom relief for depression. The purpose of this study is to assess the effectiveness and safety of use of transmucosal ketamine in treatment of PSD. We hypothesize that fast acting antidepressant effects can be achieved with tolerable side effects for translation into the general post-stroke population. To test our hypothesis, the specific aim is to: (1) demonstrate that transmucosal administration of ketamine is feasible within the post-stroke depression population and has tolerable side effects. Exploratory aims will include assessment if ketamine also produces fast acting antidepressant effects.
Interventions
DRUGKetamine
Weight-based ketamine dose will be prepared and delivered personally to study physician or study personnel by pharmacy personnel as is done during standard protocol for use of ketamine not part of a clinical study.
Sponsors
West Virginia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will be an open-label study of eligible male and female patients and minorities diagnosed with post stroke depression (PSD) conducted by West Virginia University faculty and research associates.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women (18 years of age or older) of any ethnicity diagnosed with Major Depressive Disorder (DSM-V criteria), who have had failed to respond to prior therapy (as defined as at least one anti-depressant trial or patient was intolerant or noncompliant with anti-depressive medications). * Willing to take the study drug ketamine on 2 separate occasions and comply with instructions for testing. * Understands and willing to undergo risks associated with adverse effects of study medications. * Willing to comply with restrictions and instructions disclosed in the consent form.
Exclusion criteria
* Patients with blood pressure over 150 systolic or heart rate over 110 on day of medication administration * Patients with a diagnosis of epilepsy * Patients with a significant history of high intraocular pressure. * Patients with life threatening medical problems. * Participant is pregnant or breastfeeding. * Infants and children * Patients who lack medical decision-making capacity * Patients who would require medication adjustment during time in the study. * Known hypersensitivity to the study drug (ketamine). * Unwilling to undergo risks associated with adverse effects of study drugs. * Unwilling to comply with restrictions and instructions disclosed in the consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms measured by the MADRS. | 14-day dosing period. | The Montgomery-Asberg Depression Rating Scale is a ten-item diagnostic questionnaire used by mental health clinicians to measure the severity of depressive episodes in subjects with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Reduction of MADRS = 50% drop in total score as compared to baseline, a score of 0-8 indicating NO depression OR a decrease from a more severe category to a more mild one. |
| Change in depressive symptoms measured by the MADRS-S. | 14-day dosing period. | Montgomery Asberg Depression Rating Scale Self-assessment (MADRS-S). The overall score ranges from 0-54 with a higher scores indicating more depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects will be evaluated using the PRISE. | 14-day dosing period. | Patient-Rated Inventory of Side Effects (PRISE), perceived tolerance per patient report |
Countries
United States
Contacts
Primary ContactAmelia Adcock
Outcome results
None listed