Treatment Resistant DepressionPhase 2NCT05414422
A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
A Phase 2 study testing PCN-101 in people with Treatment Resistant Depression, run by Perception Neuroscience at 21 sites in 3 countries.
Trial summary
This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment [Day 1]), and post-treatment follow-up (7 and 14 days after infusion on Days 8 and 15, respectively). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- PCN-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 1 Feb 2022to 10 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving and give signed informed consent
- Weigh >= 50 kg and have a body mass index >= 18 and <= 35
- Diagnosis of recurrent major depressive disorder (MDD) without psychotic features per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), confirmed by Mini-International Neuropsychiatric Interview
- Hamilton Depression Rating Scale total score > 20
- Inadequate response to at least 2 antidepressants in the current episode of depression that were given for >= 6 weeks
- Stable oral antidepressant treatment without dose change for at least 30 days
Who cannot join
- History of, or current signs and symptoms of diseases or conditions that would make participation not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments
- History of moderate or severe head trauma or other neurological disorders, neurodegenerative disorder or systemic medical diseases that are in the opinion of the Investigator likely to interfere with the conduct of the study or confound the study assessments
- Has a primary DSM-V diagnosis of current (active) MDD with psychotic features, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa.
- Has a current of prior DSM-V diagnosis of a primary psychotic disorder, bipolar or related disorders, intellectual or autism spectrum disorder, or borderline personality disorder
- Has any significant disease or disorder that in the opinion of the investigator, may either put the subject at risk because of participation in the study, influence the results of the study, or affect the subject's ability to participate in the study
- Has uncontrolled hypertension, despite medication, at Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg or any past history of hypertensive crisis.
Show all 28Show fewer
- Has an abnormal ECG of clinical relevance at screening or baseline
- Has known history of, or positive serology for human immunodeficiency virus, hepatitis B surface antigen, hepatitis C infection
- Has a history of malignancy within the 5 years prior to screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy that in the opinion of the investigator, with concurrence with the Sponsor's Medical Monitor, is considered to have minimal risk of recurrence)
- Has homicidal ideation/intent per the Investigator's clinical judgment, or has suicidal ideation with some intent to act within 1 month prior to the start of screening per the Investigator's clinical judgement or based on the C-SSRS, or a history of suicidal behavior within the past year prior to the start of the screening/prospective observational phase
- Has had major surgery within the 4 weeks before screening, or will not have fully recovered from surgery or planned surgery during the time the subject is expected to participate in the study
- Has moderately impaired hepatic function at screening, defined as serum alanine aminotransferase or aspartate aminotransferase > 2 × upper limit of normal or total bilirubin > 2 × upper limit of normal
- Has received any disallowed therapies as follows:
- Receipt of a known potent inhibitor of hepatic cytochrome P450 (CYP) 2B6, or CYP3A, activity within 1 week or within a period 5 times the drug's half-life, whichever is longer, before the first administration of study drug on Day 1
- Treatment with a disallowed antipsychotic within the past 30 days prior to screening, except subjects who are on stable doses of quetiapine, aripiprazole, brexpiprazole, or olanzapine prescribed as adjunct treatment for depression (without psychosis) may be included in the study
- Any changes in psychotropic medication type or dose within the past 30 days prior to screening
- Treatment with monoamine oxidase inhibitors currently or within the past 30 days of screening
- Doses of oral contraception should not contain more than 30 micrograms of ethinyl estradiol per day
- Has initiated psychotherapy or acupuncture acupuncture within the past 90 days of screening. Patients planning to initiate individual or group therapy during the study are also not eligible
- Has received electroconvulsive therapy, transcranial magnetic stimulation, vagal nerve stimulation, deep brain stimulation, or other brain stimulation treatment within the past 4 weeks or currently used as either an acute or maintenance treatment of depression
- Has received any IP within 30 days or 5 half-lives
- Has a history of substance abuse (drug or alcohol) or dependence (except nicotine or caffeine) within the previous 6 months prior to the screening visit
- Has a history of previous nonresponse to ketamine, R-ketamine or S-ketamine, or has received 8 or more doses of ketamine, R-ketamine or S-ketamine in their lifetime
- Has a previous history of intolerance to ketamine, R-ketamine, or S-ketamine
- History of abuse of ketamine, R-ketamine, S-ketamine, or phencyclidine
- Subjects should not consume grapefruit, grapefruit juice, or Seville orange related products for 72 hours before IP administration and throughout the study
- Has the presence of clinically relevant long-term COVID-19 symptoms. Has current signs or symptoms of COVID-19
- COVID-19 vaccination is allowed as long as the doses are administered ≥ 30 days before study drug administration; vaccination is not allowed during the course of the study
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States13 sites
Hassman Research Institute
Berlin, New Jersey, 08009
Midwest Clinical Research Center
Dayton, Ohio, 45417
Insite Clinical Research LLC; Inpatient facility name: Serenity
DeSoto, Texas, 75115
CNS Network
Garden Grove, California, 92845
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
Synergy San Diego
Lemon Grove, California, 91945
Preferred Research Partners
Little Rock, Arkansas, 72211
Psych Atlanta
Marietta, Georgia, 30060
Premier Clinical Research Institute Inc.
Miami, Florida, 33122
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720
NRC Research Institute
Orange, California, 92868
Princeton Medical Institute
Princeton, New Jersey, 08540
Pillar Clinical Research, LLC
Richardson, Texas, 75080
Germany4 sites
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, 60528
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, 09648
Somni bene GmbH
Schwerin, 19053
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Poland4 sites
Indywidualna Specjalistyczna Praktyka Lekarska
Gdansk, 80-438
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
Wojewodzki Szpital Dla Nerwowo i Psychicznie Chorych
Gmina Świecie, 86-100
Prywatny Gabinet Lekarski Jaroslaw Strzelec
Tuszyn, 95-080
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of Intravenous PCN-101 in Treatment Resistant Depression
This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment [Day 1]), and post-treatment follow-up (7 and 14 days after infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a blinded manner.
- Conditions
- Treatment Resistant Depression
- Being tested
- PCN-101, Placebo
- Keywords
- PCN-101, R-ketamine
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCN-101Drug
Also called R-ketamine
Concentrate for solution for infusion
PlaceboDrug
Concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| PCN-101 30 mg | Experimental | PCN-101 30 mg Receives: Drug: PCN-101 |
| PCN-101 60 mg | Experimental | PCN-101 60 mg Receives: Drug: PCN-101 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours
Change from baseline to 24 hours after the start of infusion in the Montgomery Asberg Depression Rating Scale (MADRS). The overall score ranges from 0 to 60. Higher scores indicates more severe depression.
Measured: 24 hours
Secondary outcomes (9)
Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement
Proportion of subjects with >= 50% improvement in MADRS total score from predose. The overall score ranges from 0 to 60. Higher scores indicates more severe depression.
Measured: 2 hours, 4 hours, 24 hours, 7 days and 14 days
Montgomery Asberg Depression Rating Scale (MADRS) <= 10
Proportion of subjects with remission (MADRS total score <= 10). The overall score ranges from 0 to 60. Higher scores indicates more severe depression.
Measured: 24 hours, 7 days and 14 days
Hamilton Depression Rating Scale (HAM-D) Change From Baseline
Change from Baseline in HAM-D. The total score across the 17 items could range from 0 to 52. Higher scores indicate more severe depression
Measured: 7 days and 14 days
Generalized Anxiety Disorder (GAD-7) Change From Baseline
Change from Baseline in GAD-7. The total score of the 7 items range from 0 to 21. Higher scores indicate more anxiety.
Measured: 24 hours, 7 days and 14 days
Clinical Global Impression - Severity (CGI-S) Change From Baseline
Change from Baseline in CGI-S. The score ranged from 0 to 7. Higher scores indicate a more severe or worsening of condition.
Measured: 24 hours, 7 days and 14 days
Clinical Global Impression - Improvement (CGI-I)
This score ranges from 0 to 7. Higher scores indicate a more severe or worsening of the condition
Measured: 24 hours, 7 days and 14 days
Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline
Change from Baseline in QIDS-SR-16. Total score ranges from 0 to 42. Higher scores indicate more severe depression.
Measured: 24 hours, 7 days and 14 days
European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline
Change from Baseline in EQ-5D-3L. The visual analogue scale ranges from 0 to 100. Higher scores indicate a better health state.
Measured: 24 hours, 7 days and 14 days
Treatment-emergent Adverse Events Summarized by Treatment Group, System Organ Class and Preferred Term
The number of participants in each treatment group with treatment-emergent adverse events categorized using MedDRA v24.0 or higher
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Feb 2022
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treatment Resistant DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perception Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Precision For Medicine, IQVIA Biotech
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Perception Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414422
- Sponsor's protocol ID
- PCN-101-21
- Status last verified
- Dec 2022
- First submitted
- 27 May 2022
- Last updated
- 4 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of Intravenous PCN-101 in Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT05414422
- Acronym / sponsor ID
- PCN-101-21
- Conditions
- Treatment Resistant Depression
- Keywords
- PCN-101, R-ketamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Perception NeuroscienceIndustry (pharma, biotech, devices)
- Collaborators
- Precision For Medicine, IQVIA Biotech
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Posted 4 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment [Day 1]), and post-treatment follow-up (7 and 14 days after infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a blinded manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCN-101 30 mg | Experimental | Drug: PCN-101PCN-101 30 mg |
| PCN-101 60 mg | Experimental | Drug: PCN-101PCN-101 60 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Capable of giving and give signed informed consent
- Weigh >= 50 kg and have a body mass index >= 18 and <= 35
- Diagnosis of recurrent major depressive disorder (MDD) without psychotic features per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), confirmed by Mini-International Neuropsychiatric Interview
- Hamilton Depression Rating Scale total score > 20
- Inadequate response to at least 2 antidepressants in the current episode of depression that were given for >= 6 weeks
Key exclusion criteria (28 listed)
- History of, or current signs and symptoms of diseases or conditions that would make participation not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments
- History of moderate or severe head trauma or other neurological disorders, neurodegenerative disorder or systemic medical diseases that are in the opinion of the Investigator likely to interfere with the conduct of the study or confound the study assessments
- Has a primary DSM-V diagnosis of current (active) MDD with psychotic features, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa.
- Has a current of prior DSM-V diagnosis of a primary psychotic disorder, bipolar or related disorders, intellectual or autism spectrum disorder, or borderline personality disorder
- Has any significant disease or disorder that in the opinion of the investigator, may either put the subject at risk because of participation in the study, influence the results of the study, or affect the subject's ability to participate in the study
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 |
|---|---|---|
| PCN-101Also: R-ketamineConcentrate for solution for infusion | Drug | PCN-101 30 mg, PCN-101 60 mg |
| PlaceboConcentrate for solution for infusion | Drug | Placebo |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours
Time frame: 24 hours
Change from baseline to 24 hours after the start of infusion in the Montgomery Asberg Depression Rating Scale (MADRS). The overall score ranges from 0 to 60. Higher scores indicates more severe depression.
9 secondary outcomes
Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement
Time frame: 2 hours, 4 hours, 24 hours, 7 days and 14 days
Montgomery Asberg Depression Rating Scale (MADRS) <= 10
Time frame: 24 hours, 7 days and 14 days
Hamilton Depression Rating Scale (HAM-D) Change From Baseline
Time frame: 7 days and 14 days
Generalized Anxiety Disorder (GAD-7) Change From Baseline
Time frame: 24 hours, 7 days and 14 days
Clinical Global Impression - Severity (CGI-S) Change From Baseline
Time frame: 24 hours, 7 days and 14 days
Clinical Global Impression - Improvement (CGI-I)
Time frame: 24 hours, 7 days and 14 days
Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline
Time frame: 24 hours, 7 days and 14 days
European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline
Time frame: 24 hours, 7 days and 14 days
Treatment-emergent Adverse Events Summarized by Treatment Group, System Organ Class and Preferred Term
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Chief Medical Officer study director
Perception Neuroscience
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCN-101 in people with Treatment Resistant Depression, run by Perception Neuroscience at 21 sites in 3 countries.
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 6 inclusion and 28 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: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours (time frame: 24 hours). 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 4 Jun 2024.