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Ketamine for Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03721900
Recruitment Status : Unknown
Verified April 2019 by Shenox Pharmaceuticals, LLC.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Shenox Pharmaceuticals, LLC

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE October 26, 2018
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE December 28, 2018
Estimated Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • Pharmacokinetics of SHX-001 (Cmax) [ Time Frame: 1 week ]
    Maximum observed plasma concentration
  • Pharmacokinetics of SHX-001 (Tmax) [ Time Frame: 1 week ]
    Time of maximum observed plasma concentration
  • Pharmacokinetics of SHX-001 (T1/2) [ Time Frame: 1 week ]
    Apparent terminal half-life
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 23, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ketamine for Major Depressive Disorder
Official Title  ICMJE A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: SHX-001 Active low dose
    ketamine transdermal patch
    Other Name: Ketamine transdermal patch
  • Drug: Placebo
    transdermal patch
    Other Name: placebo transdermal patch
  • Drug: SHX-001 Active High dose
    ketamine transdermal patch
    Other Name: ketamine transdermal patch
Study Arms  ICMJE
  • Experimental: SHX-001 Active Low Dose
    Ketamine transdermal patch
    Intervention: Drug: SHX-001 Active low dose
  • Placebo Comparator: Placebo
    placebo transdermal patch
    Intervention: Drug: Placebo
  • Experimental: SHX-001 Active high dose
    ketamine transdermal patch
    Intervention: Drug: SHX-001 Active High dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 6, 2019
Estimated Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03721900
Other Study ID Numbers  ICMJE SHX-C301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shenox Pharmaceuticals, LLC
Study Sponsor  ICMJE Shenox Pharmaceuticals, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mason Freeman, MD Massachusetts General Hospital
PRS Account Shenox Pharmaceuticals, LLC
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP