Treatment Resistant Depression
Conditions
Keywords
PCN-101, R-ketamine
Brief 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). 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.
Interventions
DRUGPCN-101
Concentrate for solution for infusion
DRUGPlacebo
Concentrate for solution for infusion
Sponsors
Precision For Medicine
IQVIA Biotech
Perception Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 24 hours, 7 days and 14 days | Proportion of subjects with remission (MADRS total score \<= 10). The overall score ranges from 0 to 60. Higher scores indicates more severe depression. |
| Hamilton Depression Rating Scale (HAM-D) Change From Baseline | 7 days and 14 days | 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 |
| Generalized Anxiety Disorder (GAD-7) Change From Baseline | 24 hours, 7 days and 14 days | Change from Baseline in GAD-7. The total score of the 7 items range from 0 to 21. Higher scores indicate more anxiety. |
| Clinical Global Impression - Severity (CGI-S) Change From Baseline | 24 hours, 7 days and 14 days | Change from Baseline in CGI-S. The score ranged from 0 to 7. Higher scores indicate a more severe or worsening of condition. |
| Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 2 hours, 4 hours, 24 hours, 7 days and 14 days | 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. |
| Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 24 hours, 7 days and 14 days | Change from Baseline in QIDS-SR-16. Total score ranges from 0 to 42. Higher scores indicate more severe depression. |
| European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 24 hours, 7 days and 14 days | Change from Baseline in EQ-5D-3L. The visual analogue scale ranges from 0 to 100. Higher scores indicate a better health state. |
| Treatment-emergent Adverse Events Summarized by Treatment Group, System Organ Class and Preferred Term | 14 days | The number of participants in each treatment group with treatment-emergent adverse events categorized using MedDRA v24.0 or higher |
| Clinical Global Impression - Improvement (CGI-I) | 24 hours, 7 days and 14 days | This score ranges from 0 to 7. Higher scores indicate a more severe or worsening of the condition |
Countries
Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCN-101 30 mg PCN-101 30 mg
PCN-101: Concentrate for solution for infusion | 33 |
| PCN-101 60 mg PCN-101 60 mg
PCN-101: Concentrate for solution for infusion | 35 |
| Placebo Placebo
Placebo: Concentrate for solution for infusion | 33 |
| Total | 101 |
Baseline characteristics
| Characteristic | PCN-101 30 mg | PCN-101 60 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 11.36 | 43.3 years STANDARD_DEVIATION 12.28 | 44.3 years STANDARD_DEVIATION 11.44 | 44.9 years STANDARD_DEVIATION 11.71 |
| HAM-D | 24.8 total score STANDARD_DEVIATION 3.06 | 24.1 total score STANDARD_DEVIATION 3.09 | 24.5 total score STANDARD_DEVIATION 4.79 | 24.4 total score STANDARD_DEVIATION 3.7 |
| MADRS | 29.5 total score STANDARD_DEVIATION 4.74 | 29.7 total score STANDARD_DEVIATION 4.45 | 29.9 total score STANDARD_DEVIATION 5.44 | 29.7 total score STANDARD_DEVIATION 4.84 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Europe | 24 participants | 25 participants | 25 participants | 74 participants |
| Region of Enrollment United States | 9 participants | 10 participants | 8 participants | 27 participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 20 Participants | 61 Participants |
| Sex: Female, Male Male | 11 Participants | 16 Participants | 13 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 11 / 33 | 18 / 35 | 18 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 35 | 0 / 34 |
Outcome results
Primary
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.
Time frame: 24 hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours | -13.7 score on a scale | Standard Error 1.75 |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours | -15.3 score on a scale | Standard Error 1.69 |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours | -13.7 score on a scale | Standard Error 1.76 |
Secondary
Clinical Global Impression - Improvement (CGI-I)
This score ranges from 0 to 7. Higher scores indicate a more severe or worsening of the condition
Time frame: 24 hours, 7 days and 14 days
Population: Subjects early terminated from the study after discharge also this assessment was not completed at all visits by the clinician
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PCN-101 30 mg | Clinical Global Impression - Improvement (CGI-I) | 7 days | 2.8 score on a scale | Standard Error 0.24 |
| PCN-101 30 mg | Clinical Global Impression - Improvement (CGI-I) | 24 hours | 2.3 score on a scale | Standard Error 0.2 |
| PCN-101 30 mg | Clinical Global Impression - Improvement (CGI-I) | 14 days | 3.2 score on a scale | Standard Error 0.25 |
| PCN-101 60 mg | Clinical Global Impression - Improvement (CGI-I) | 7 days | 2.3 score on a scale | Standard Error 0.23 |
| PCN-101 60 mg | Clinical Global Impression - Improvement (CGI-I) | 24 hours | 2.2 score on a scale | Standard Error 0.2 |
| PCN-101 60 mg | Clinical Global Impression - Improvement (CGI-I) | 14 days | 2.5 score on a scale | Standard Error 0.24 |
| Placebo | Clinical Global Impression - Improvement (CGI-I) | 24 hours | 2.5 score on a scale | Standard Error 0.2 |
| Placebo | Clinical Global Impression - Improvement (CGI-I) | 14 days | 3.0 score on a scale | Standard Error 0.27 |
| Placebo | Clinical Global Impression - Improvement (CGI-I) | 7 days | 2.6 score on a scale | Standard Error 0.25 |
Secondary
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.
Time frame: 24 hours, 7 days and 14 days
Population: Subjects early terminated from the study after discharge. This assessment was also not completed at all visits by the clinician.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PCN-101 30 mg | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 7 days | 3.4 score on a scale | Standard Error 0.26 |
| PCN-101 30 mg | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 24 hours | 3.0 score on a scale | Standard Error 0.23 |
| PCN-101 30 mg | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 14 days | 3.9 score on a scale | Standard Error 0.29 |
| PCN-101 60 mg | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 7 days | 3.3 score on a scale | Standard Error 0.25 |
| PCN-101 60 mg | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 24 hours | 3.0 score on a scale | Standard Error 0.23 |
| PCN-101 60 mg | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 14 days | 3.3 score on a scale | Standard Error 0.28 |
| Placebo | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 24 hours | 3.4 score on a scale | Standard Error 0.23 |
| Placebo | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 14 days | 3.7 score on a scale | Standard Error 0.31 |
| Placebo | Clinical Global Impression - Severity (CGI-S) Change From Baseline | 7 days | 3.5 score on a scale | Standard Error 0.27 |
Secondary
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.
Time frame: 24 hours, 7 days and 14 days
Population: Subject early terminated from the study after discharge
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PCN-101 30 mg | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 7 days | 12.9 score on a scale | Standard Error 3.46 |
| PCN-101 30 mg | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 24 hours | 13.9 score on a scale | Standard Error 3.3 |
| PCN-101 30 mg | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 14 days | 8.2 score on a scale | Standard Error 3.75 |
| PCN-101 60 mg | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 7 days | 14.1 score on a scale | Standard Error 3.29 |
| PCN-101 60 mg | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 24 hours | 17.9 score on a scale | Standard Error 3.2 |
| PCN-101 60 mg | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 14 days | 9.8 score on a scale | Standard Error 3.58 |
| Placebo | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 24 hours | 14.9 score on a scale | Standard Error 3.24 |
| Placebo | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 14 days | 11.0 score on a scale | Standard Error 3.7 |
| Placebo | European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline | 7 days | 14.4 score on a scale | Standard Error 3.4 |
Secondary
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.
Time frame: 24 hours, 7 days and 14 days
Population: Subjects early terminated from the study after discharge
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PCN-101 30 mg | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 7 days | -5.8 score on a scale | Standard Error 0.89 |
| PCN-101 30 mg | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 24 hours | -6.5 score on a scale | Standard Error 0.84 |
| PCN-101 30 mg | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 14 days | -3.7 score on a scale | Standard Error 0.87 |
| PCN-101 60 mg | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 7 days | -5.8 score on a scale | Standard Error 0.85 |
| PCN-101 60 mg | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 24 hours | -7.5 score on a scale | Standard Error 0.83 |
| PCN-101 60 mg | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 14 days | -4.3 score on a scale | Standard Error 0.84 |
| Placebo | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 24 hours | -7.4 score on a scale | Standard Error 0.85 |
| Placebo | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 14 days | -5.3 score on a scale | Standard Error 0.88 |
| Placebo | Generalized Anxiety Disorder (GAD-7) Change From Baseline | 7 days | -5.8 score on a scale | Standard Error 0.89 |
Secondary
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
Time frame: 7 days and 14 days
Population: Subjects early terminated after discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PCN-101 30 mg | Hamilton Depression Rating Scale (HAM-D) Change From Baseline | 7 days | -8.6 score on a scale | Standard Deviation 7.61 |
| PCN-101 30 mg | Hamilton Depression Rating Scale (HAM-D) Change From Baseline | 14 days | -6.1 score on a scale | Standard Deviation 7.14 |
| PCN-101 60 mg | Hamilton Depression Rating Scale (HAM-D) Change From Baseline | 7 days | -9.3 score on a scale | Standard Deviation 8.09 |
| PCN-101 60 mg | Hamilton Depression Rating Scale (HAM-D) Change From Baseline | 14 days | -8.7 score on a scale | Standard Deviation 8.7 |
| Placebo | Hamilton Depression Rating Scale (HAM-D) Change From Baseline | 7 days | -9.4 score on a scale | Standard Deviation 7.07 |
| Placebo | Hamilton Depression Rating Scale (HAM-D) Change From Baseline | 14 days | -8.1 score on a scale | Standard Deviation 7.21 |
Secondary
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.
Time frame: 24 hours, 7 days and 14 days
Population: Subject early terminated from the study after discharge
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 7 days | 7 Participants |
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 24 hours | 10 Participants |
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 14 days | 4 Participants |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 7 days | 9 Participants |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 24 hours | 15 Participants |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 14 days | 10 Participants |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 24 hours | 9 Participants |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 14 days | 4 Participants |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) <= 10 | 7 days | 4 Participants |
Secondary
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.
Time frame: 2 hours, 4 hours, 24 hours, 7 days and 14 days
Population: Subjects early terminated from the study after discharge
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 7 days | 9 Participants |
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 24 hours | 19 Participants |
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 2 hours | 9 Participants |
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 4 hours | 9 Participants |
| PCN-101 30 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 14 days | 5 Participants |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 24 hours | 16 Participants |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 2 hours | 11 Participants |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 4 hours | 13 Participants |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 7 days | 12 Participants |
| PCN-101 60 mg | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 14 days | 12 Participants |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 14 days | 7 Participants |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 7 days | 9 Participants |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 2 hours | 6 Participants |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 24 hours | 16 Participants |
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement | 4 hours | 9 Participants |
Secondary
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.
Time frame: 24 hours, 7 days and 14 days
Population: Subjects early terminated from the study after discharge
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PCN-101 30 mg | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 7 days | -8.4 score on a scale | Standard Error 1.3 |
| PCN-101 30 mg | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 24 hours | -9.6 score on a scale | Standard Error 1.23 |
| PCN-101 30 mg | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 14 days | -6.0 score on a scale | Standard Error 1.42 |
| PCN-101 60 mg | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 7 days | -10.1 score on a scale | Standard Error 1.26 |
| PCN-101 60 mg | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 24 hours | -10.7 score on a scale | Standard Error 1.21 |
| PCN-101 60 mg | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 14 days | -9.6 score on a scale | Standard Error 1.38 |
| Placebo | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 24 hours | -10.5 score on a scale | Standard Error 1.25 |
| Placebo | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 14 days | -8.3 score on a scale | Standard Error 1.46 |
| Placebo | Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline | 7 days | -9.4 score on a scale | Standard Error 1.32 |
Secondary
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
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCN-101 30 mg | Treatment-emergent Adverse Events Summarized by Treatment Group, System Organ Class and Preferred Term | 11 Participants |
| PCN-101 60 mg | Treatment-emergent Adverse Events Summarized by Treatment Group, System Organ Class and Preferred Term | 19 Participants |
| Placebo | Treatment-emergent Adverse Events Summarized by Treatment Group, System Organ Class and Preferred Term | 18 Participants |