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Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression

Primary Purpose

Treatment Resistant Depression, Major Depressive Disorder, Analgesia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VTS-K
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Maimonides Medical Center, Psychiatry, Ketamine, Aspirin, Antipyretics, Peripheral Nervous System Agents, Sensory System Agents, NMDA receptor antagonist, Anesthetics, Dissociative, Excitatory Amino Acid Antagonists, Excitatory Amino Acid Agents, Cyclooxygenase Inhibitors, Oral Medications for depression

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients with Treatment Resistant Depression with Montgomery-Asberg Depression Rating Scale score >22 upon presentation to the clinic Treatment Resistant Depression is defined as Major Depressive Disorder that does not cease after at least 6 week trial of another class of antidepressants Unipolar Depression Exclusion Criteria: Adult patients with recent or current suicidal ideation with an intent to act, homicidal ideations with an intent to act History of Bipolar Disorder, Obsessive Compulsive Disorder, antisocial personality disorder, borderline personality disorder, and congestive cardiac failure Uncontrolled hypertension (BP >140 mm Hg systolic and/or >90 mm Hg diastolic on two separate readings at the time of screening) or on 2 medications for hypertension Patients with unstable vital signs (systolic blood pressure <90 or>160 mm Hg, pulse rate <50 or >150 beats/min, and respiration rate <10 or >30 breaths/min), History of Gastrointestinal hemorrhage, renal and hepatic insufficiency Allergy to Ketamine or Aspirin Active Substance Abuse Disorder Active psychosis Active Peptic Ulcer Disease Lithium Therapy Swallowing difficulty Consumption of Aspirin or NSAID's within 6 hours of arrival to the site Previous participation in this study; a patient may not re-enroll in another study while in this study Pregnant or breastfeeding

Sites / Locations

  • Maimonides Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention Group

Arm Description

All individuals 18 years old or older who have Major Depressive Disorder and have failed to achieve response or remission to at least one proven antidepressant trial with minimum affective dose for a duration of at least 6 weeks.

Outcomes

Primary Outcome Measures

Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS).
Montgomery-Asberg Depression Rating Scale has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total Montgomery Asberg Depression Rating Scale (MADRS) score from the baseline (pre-dose day 1 ) and on day 7

Secondary Outcome Measures

A change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) from the baseline (pre-dose on day 1 and 4) and 2 hours post-medication administration
Montgomery-Asberg Depression Rating Scale has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total Montgomery-Asberg Depression Rating Scale prior to dose administration on Day 1 and Day 4 compared to 2 hours after dose administration for each day.
Clinician-Administered Dissociative States Scale (CADSS)
Measurement of dissociative symptoms. Clinician Administered Dissociative States Scale (CADSS) comprises 23 subjective items, each on a 5 point scale, a "0" represents absence of any adverse events and "4" represents a severely bothersome side effect. A total score ranges from 0-92, a lower score indicates a better health status. :
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA)
Overall side effects as measured by the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). SERSDA has 9 items, each graded on a five point scale, with "0" representing the absence of any adverse effects and "4" representing a severely bothersome side effect.
Maximal sedative effects using Modified Observer's Assessment of Alertness and Sedation ( MOAA/S)
Modified Observer's Alertness/Sedation Scale ( MOAA/S) uses a 6 point scale. A "0" indicates failure to respond to painful stimulus, "5" represents fully alert. .

Full Information

First Posted
October 31, 2022
Last Updated
July 2, 2023
Sponsor
Maimonides Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05615948
Brief Title
Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression
Official Title
An Open-Label Clinical Trial of Simultaneous Administration of Oral Aspirin and Ketamine as Adjunct to Oral Antidepressant Therapy in Treatment-Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimonides Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the effects of simultaneous administration of oral aspirin and oral ketamine as a therapeutic for those with Treatment Resistant Depression.
Detailed Description
The objective of the study is to evaluate the effect of simultaneous administration of oral aspirin and oral ketamine, formulated for partial release in the oral cavity and partially swallowed, as an adjunct to the oral antidepressant on depressive symptoms in patients suffering from Treatment Resistant Depression (TRD) in outpatient Psychiatric Clinic. Investigators will evaluate the effects of simultaneous administration of oral aspirin and oral ketamine, on depressive symptoms. This is a prospective open-label, proof of concept clinical trial of simultaneous administration of proprietary formulations of oral aspirin and ketamine in medically stable adult patients with a diagnosis of Treatment Resistant Depression. All eligible participants will commit to three visits. The first two visits are in-person at the clinic for administration of oral ketamine and oral aspirin. Participants will be under observation for at least two hours. Study participant's vital signs will be monitored, periodically. The last visit will be conducted remotely. Adult patients 18 years of age and older, with a diagnosis of TRD presenting to the psychiatric clinic will be screened for enrollment by study team. :

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Major Depressive Disorder, Analgesia, Ketamine, Peripheral Nervous System Agents, Central Nervous System Depressants, Neurotransmitter Agents, Anti-Inflammatory Agents, Physiological Effects of Drugs, Sensory System Agents, Analgesics, Non-Narcotic, Anti-Inflammatory Agents, Non-Steroidal, Depressive Symptoms
Keywords
Maimonides Medical Center, Psychiatry, Ketamine, Aspirin, Antipyretics, Peripheral Nervous System Agents, Sensory System Agents, NMDA receptor antagonist, Anesthetics, Dissociative, Excitatory Amino Acid Antagonists, Excitatory Amino Acid Agents, Cyclooxygenase Inhibitors, Oral Medications for depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Other
Arm Description
All individuals 18 years old or older who have Major Depressive Disorder and have failed to achieve response or remission to at least one proven antidepressant trial with minimum affective dose for a duration of at least 6 weeks.
Intervention Type
Drug
Intervention Name(s)
VTS-K
Other Intervention Name(s)
Ketamine + Aspirin
Intervention Description
Proprietary oral formulation of 486mg aspirin and 80mg ketamine
Primary Outcome Measure Information:
Title
Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS).
Description
Montgomery-Asberg Depression Rating Scale has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total Montgomery Asberg Depression Rating Scale (MADRS) score from the baseline (pre-dose day 1 ) and on day 7
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
A change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) from the baseline (pre-dose on day 1 and 4) and 2 hours post-medication administration
Description
Montgomery-Asberg Depression Rating Scale has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total Montgomery-Asberg Depression Rating Scale prior to dose administration on Day 1 and Day 4 compared to 2 hours after dose administration for each day.
Time Frame
4 Days
Title
Clinician-Administered Dissociative States Scale (CADSS)
Description
Measurement of dissociative symptoms. Clinician Administered Dissociative States Scale (CADSS) comprises 23 subjective items, each on a 5 point scale, a "0" represents absence of any adverse events and "4" represents a severely bothersome side effect. A total score ranges from 0-92, a lower score indicates a better health status. :
Time Frame
4 Days
Title
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA)
Description
Overall side effects as measured by the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). SERSDA has 9 items, each graded on a five point scale, with "0" representing the absence of any adverse effects and "4" representing a severely bothersome side effect.
Time Frame
4 Days
Title
Maximal sedative effects using Modified Observer's Assessment of Alertness and Sedation ( MOAA/S)
Description
Modified Observer's Alertness/Sedation Scale ( MOAA/S) uses a 6 point scale. A "0" indicates failure to respond to painful stimulus, "5" represents fully alert. .
Time Frame
4 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with Treatment Resistant Depression with Montgomery-Asberg Depression Rating Scale score >22 upon presentation to the clinic Treatment Resistant Depression is defined as Major Depressive Disorder that does not cease after at least 6 week trial of another class of antidepressants Unipolar Depression Exclusion Criteria: Adult patients with recent or current suicidal ideation with an intent to act, homicidal ideations with an intent to act History of Bipolar Disorder, Obsessive Compulsive Disorder, antisocial personality disorder, borderline personality disorder, and congestive cardiac failure Uncontrolled hypertension (BP >140 mm Hg systolic and/or >90 mm Hg diastolic on two separate readings at the time of screening) or on 2 medications for hypertension Patients with unstable vital signs (systolic blood pressure <90 or>160 mm Hg, pulse rate <50 or >150 beats/min, and respiration rate <10 or >30 breaths/min), History of Gastrointestinal hemorrhage, renal and hepatic insufficiency Allergy to Ketamine or Aspirin Active Substance Abuse Disorder Active psychosis Active Peptic Ulcer Disease Lithium Therapy Swallowing difficulty Consumption of Aspirin or NSAID's within 6 hours of arrival to the site Previous participation in this study; a patient may not re-enroll in another study while in this study Pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theresa Jacob, MPH, PhD
Phone
718-283-7162
Email
tjacob@maimonidesmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Otuwe Anya, BA
Phone
718-283-8170
Email
oanya@maimonidesmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepan Singh, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Otuwe Anya, BA
Phone
718-283-8170
Email
oanya@maimonidesmed.org
First Name & Middle Initial & Last Name & Degree
Hasan Mustafic, BA
Phone
718-283-8170
Email
hmustafic@maimonidesmed.org
First Name & Middle Initial & Last Name & Degree
Huifen Feng, MD
First Name & Middle Initial & Last Name & Degree
Theresa Jacob, MPH, PhD
First Name & Middle Initial & Last Name & Degree
Deepan Singh, MD

12. IPD Sharing Statement

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Results Reference
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Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression

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