Post-stroke DepressionPhase 1NCT04876066
Use of Transmucosal Ketamine in Post Stroke Depression
A Phase 1 study testing Ketamine in people with Post-stroke Depression, run by West Virginia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
WVU Medicine
Morgantown, West Virginia, 26506
About this study
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.
- Conditions
- Post-stroke Depression
- Being tested
- Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine dose | Experimental | The recommended ketamine dose of 0.5 mg/kg will be administered using a transmucosal route of administration wherein the subject will be instructed to place the liquid solution beneath their tongue and hold it in their mouth for 5 minutes. The pharmacy will prepare two 0.5 mg/kg solutions of ketamine in two syringes for each subject based on subject weight. For example, a 70 kg adult subject will receive a 0.35 mL solution of ketamine. The patient will receive a dose every 7 days for two weeks, for a total of two doses. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms measured by the MADRS.
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.
Measured: 14-day dosing period.
Change in depressive symptoms measured by the MADRS-S.
Montgomery Asberg Depression Rating Scale Self-assessment (MADRS-S). The overall score ranges from 0-54 with a higher scores indicating more depression.
Measured: 14-day dosing period.
Secondary outcomes (1)
Side effects will be evaluated using the PRISE.
Patient-Rated Inventory of Side Effects (PRISE), perceived tolerance per patient report
Measured: 14-day dosing period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start30 Nov 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amelia Adcock, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876066
- Sponsor's protocol ID
- 1903509572
- Status last verified
- Apr 2022
- First submitted
- 3 May 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transmucosal Ketamine in Post Stroke Depression
- ClinicalTrials.gov ID
- NCT04876066
- Acronym / sponsor ID
- 1903509572
- Conditions
- Post-stroke Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine dose | Experimental | Drug: KetamineThe recommended ketamine dose of 0.5 mg/kg will be administered using a transmucosal route of administration wherein the subject will be instructed to place the liquid solution beneath their tongue and hold it in their mouth for 5 minutes. The pharmacy will prepare two 0.5 mg/kg solutions of ketamine in two syringes for each subject based on subject weight. For example, a 70 kg adult subject will receive a 0.35 mL solution of ketamine. The patient will receive a dose every 7 days for two weeks, for a total of two doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineWeight-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. | Drug | Ketamine dose |
Primary outcome
Change in depressive symptoms measured by the MADRS.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Side effects will be evaluated using the PRISE.
Time frame: 14-day dosing period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine in people with Post-stroke Depression, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amelia Adcock ((304) 293-3527, akadcock@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms measured by the MADRS. (time frame: 14-day dosing period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.