- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03721900
Ketamine for Major Depressive Disorder
April 24, 2019 updated by: Shenox Pharmaceuticals, LLC
A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders
The purpose of this study is to measure the amount of ketamine in blood over time in subjects diagnosed with Major Depressive Disorder (MDD) and explore the anti-depressive effects of ketamine delivered by transdermal patch.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
SHX-C301 is a Phase 1, first in human, single-blind, multi-center clinical study to evaluate the pharmacokinetics (PK), safety and antidepressant effects of SHX-001 transdermal patch low dose delivered based on prediction and high dose delivered based on the estimation from the low dose PK in subjects with MDD and sub-optimally controlled by standard of care.
Study Type
Interventional
Enrollment (Anticipated)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Gaithersburg, Maryland, United States, 20877
- Clinical Research Site
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Clinical Research Site
-
-
Ohio
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Dayton, Ohio, United States, 45417
- Clinical Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Present a current depressive episode of at least 8 weeks
- Have a body mass index (BMI) of 18-35 kg/m2 (inclusive) at screening
- Agree to use adequate methods of contraception during the study (and for X days after discharge)
Exclusion Criteria:
- A history of alcohol consumption exceeding 14 drinks/week within the 5 years before study entry.
- Use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication except ongoing stable dose of antidepressant.
- Treatment with any investigational drug, use of any known CYP3A4 enzyme-inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, St. John's Wort) or herbal supplements within 7 days prior to the first dose of study medication
- A history of drug abuse or dependence within 180 days of screening
- A febrile illness within 5 days prior to the first dose of study medication.
- A known hypersensitivity to ketamine
- A history of use ketamine for Major Depressive Disorder and did not respond to ketamine
- Recent use of ketamine in any formulation for any indication (within 4 weeks prior to screening)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHX-001 Active Low Dose
Ketamine transdermal patch
|
ketamine transdermal patch
Other Names:
|
Placebo Comparator: Placebo
placebo transdermal patch
|
transdermal patch
Other Names:
|
Experimental: SHX-001 Active high dose
ketamine transdermal patch
|
ketamine transdermal patch
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of SHX-001 (Cmax)
Time Frame: 1 week
|
Maximum observed plasma concentration
|
1 week
|
Pharmacokinetics of SHX-001 (Tmax)
Time Frame: 1 week
|
Time of maximum observed plasma concentration
|
1 week
|
Pharmacokinetics of SHX-001 (T1/2)
Time Frame: 1 week
|
Apparent terminal half-life
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-depressive effects of SHX-001
Time Frame: 1 week
|
Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated)
|
1 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety objective as measured by Adverse Events (Safety and Tolerability of SHX-001)
Time Frame: Up to 10 weeks
|
The safety and tolerability of SHX-001 transdermal patch as an adjunctive therapy to standard of care will be evaluated in subjects with MDD who are sub-optimally responsive to approved antidepressant.
|
Up to 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mason Freeman, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2018
Primary Completion (Anticipated)
June 6, 2019
Study Completion (Anticipated)
June 6, 2019
Study Registration Dates
First Submitted
October 18, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (Actual)
October 26, 2018
Study Record Updates
Last Update Posted (Actual)
April 25, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- SHX-C301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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