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Trial record 1 of 6030 for:    "Depressive Disorder" [DISEASE]
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Ketamine for Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03721900
Recruitment Status : Active, not recruiting
First Posted : October 26, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Shenox Pharmaceuticals, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SHX-001 Active low dose Drug: Placebo Drug: SHX-001 Active High dose Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Each subject will receive one of the following: placebo, 20 mg (low dose), or 40 mg (high dose). All subjects will receive doses in the same order during 3 study periods
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : June 6, 2019
Estimated Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: SHX-001 Active Low Dose
Ketamine transdermal patch
Drug: SHX-001 Active low dose
ketamine transdermal patch
Other Name: Ketamine transdermal patch

Placebo Comparator: Placebo
placebo transdermal patch
Drug: Placebo
transdermal patch
Other Name: placebo transdermal patch

Experimental: SHX-001 Active high dose
ketamine transdermal patch
Drug: SHX-001 Active High dose
ketamine transdermal patch
Other Name: ketamine transdermal patch




Primary Outcome Measures :
  1. Pharmacokinetics of SHX-001 (Cmax) [ Time Frame: 1 week ]
    Maximum observed plasma concentration

  2. Pharmacokinetics of SHX-001 (Tmax) [ Time Frame: 1 week ]
    Time of maximum observed plasma concentration

  3. Pharmacokinetics of SHX-001 (T1/2) [ Time Frame: 1 week ]
    Apparent terminal half-life


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721900


Locations
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United States, Maryland
Clinical Research Site
Gaithersburg, Maryland, United States, 20877
United States, Massachusetts
Clinical Research Site
Boston, Massachusetts, United States, 02114
United States, Ohio
Clinical Research Site
Dayton, Ohio, United States, 45417
Sponsors and Collaborators
Shenox Pharmaceuticals, LLC
Investigators
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Study Director: Mason Freeman, MD Massachusetts General Hospital

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Responsible Party: Shenox Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT03721900     History of Changes
Other Study ID Numbers: SHX-C301
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shenox Pharmaceuticals, LLC:
Depression

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action