Major Depressive DisorderPhase 1NCT03721900
Ketamine for Major Depressive Disorder
A Phase 1 study testing SHX-001 Active low dose and SHX-001 Active High dose in people with Major Depressive Disorder, run by Shenox Pharmaceuticals, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SHX-001 Active low dose and SHX-001 Active High dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Dec 2018to 6 Jun 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Research Site
Boston, Massachusetts, 02114
Clinical Research Site
Dayton, Ohio, 45417
Clinical Research Site
Gaithersburg, Maryland, 20877
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- SHX-001 Active low dose, Placebo, SHX-001 Active High dose
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHX-001 Active low doseDrug
Also called Ketamine transdermal patch
ketamine transdermal patch
PlaceboDrug
Also called placebo transdermal patch
transdermal patch
SHX-001 Active High doseDrug
Also called ketamine transdermal patch
ketamine transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| SHX-001 Active Low Dose | Experimental | Ketamine transdermal patch Receives: Drug: SHX-001 Active low dose |
| Placebo | Placebo comparator | placebo transdermal patch Receives: Drug: Placebo |
| SHX-001 Active high dose | Experimental | ketamine transdermal patch Receives: Drug: SHX-001 Active High dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of SHX-001 (Cmax)
Maximum observed plasma concentration
Measured: 1 week
Pharmacokinetics of SHX-001 (Tmax)
Time of maximum observed plasma concentration
Measured: 1 week
Pharmacokinetics of SHX-001 (T1/2)
Apparent terminal half-life
Measured: 1 week
Secondary outcomes (1)
Anti-depressive effects of SHX-001
Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start28 Dec 2018
- Primary completion6 Jun 2019 (estimated)
- Study completion6 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenox Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mason Freeman, MD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721900
- Sponsor's protocol ID
- SHX-C301
- Status last verified
- Apr 2019
- First submitted
- 18 Oct 2018
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders
- ClinicalTrials.gov ID
- NCT03721900
- Acronym / sponsor ID
- SHX-C301
- Conditions
- Major Depressive Disorder
- Keywords
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Shenox Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 6 Jun 2019 (estimated)
- Study completion
- 6 Jun 2019 (estimated)
- First posted
- 26 Oct 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| SHX-001 Active Low Dose | Experimental | Drug: SHX-001 Active low doseKetamine transdermal patch |
| Placebo | Placebo comparator | Drug: Placeboplacebo transdermal patch |
| SHX-001 Active high dose | Experimental | Drug: SHX-001 Active High doseketamine transdermal patch |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| SHX-001 Active low doseAlso: Ketamine transdermal patchketamine transdermal patch | Drug | SHX-001 Active Low Dose |
| PlaceboAlso: placebo transdermal patchtransdermal patch | Drug | Placebo |
| SHX-001 Active High doseAlso: ketamine transdermal patchketamine transdermal patch | Drug | SHX-001 Active high dose |
Primary outcome
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
1 secondary outcome
Anti-depressive effects of SHX-001
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Mason Freeman, MD study director
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHX-001 Active low dose and SHX-001 Active High dose in people with Major Depressive Disorder, run by Shenox Pharmaceuticals, LLC at 3 sites 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 3 inclusion and 8 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 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of SHX-001 (Cmax) (time frame: 1 week). The study lists 3 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 25 Apr 2019.