Trial Outcomes & Findings for A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD (NCT NCT05414422)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

24 hours

Results posted on

2024-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	PCN-101 30 mg PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo Placebo Placebo: Concentrate for solution for infusion
Overall Study STARTED	33	35	34
Overall Study COMPLETED	31	35	31
Overall Study NOT COMPLETED	2	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion	Total n=101 Participants Total of all reporting groups
HAM-D	24.8 total score STANDARD_DEVIATION 3.06 • n=33 Participants	24.1 total score STANDARD_DEVIATION 3.09 • n=35 Participants	24.5 total score STANDARD_DEVIATION 4.79 • n=33 Participants	24.4 total score STANDARD_DEVIATION 3.70 • n=101 Participants
Age, Continuous	47.2 years STANDARD_DEVIATION 11.36 • n=33 Participants	43.3 years STANDARD_DEVIATION 12.28 • n=35 Participants	44.3 years STANDARD_DEVIATION 11.44 • n=33 Participants	44.9 years STANDARD_DEVIATION 11.71 • n=101 Participants
Sex: Female, Male Female	22 Participants n=33 Participants	19 Participants n=35 Participants	20 Participants n=33 Participants	61 Participants n=101 Participants
Sex: Female, Male Male	11 Participants n=33 Participants	16 Participants n=35 Participants	13 Participants n=33 Participants	40 Participants n=101 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=33 Participants	10 participants n=35 Participants	8 participants n=33 Participants	27 participants n=101 Participants
Region of Enrollment Europe	24 participants n=33 Participants	25 participants n=35 Participants	25 participants n=33 Participants	74 participants n=101 Participants
MADRS	29.5 total score STANDARD_DEVIATION 4.74 • n=33 Participants	29.7 total score STANDARD_DEVIATION 4.45 • n=35 Participants	29.9 total score STANDARD_DEVIATION 5.44 • n=33 Participants	29.7 total score STANDARD_DEVIATION 4.84 • n=101 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours	-13.7 score on a scale Standard Error 1.75	-15.3 score on a scale Standard Error 1.69	-13.7 score on a scale Standard Error 1.76

SECONDARY outcome

Timeframe: 2 hours, 4 hours, 24 hours, 7 days and 14 days

Population: Subjects early terminated from the study after discharge

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.

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement 2 hours	9 Participants	11 Participants	6 Participants
Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement 4 hours	9 Participants	13 Participants	9 Participants
Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement 24 hours	19 Participants	16 Participants	16 Participants
Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement 7 days	9 Participants	12 Participants	9 Participants
Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement 14 days	5 Participants	12 Participants	7 Participants

SECONDARY outcome

Timeframe: 24 hours, 7 days and 14 days

Population: Subject early terminated from the study after discharge

Proportion of subjects with remission (MADRS total score \<= 10). The overall score ranges from 0 to 60. Higher scores indicates more severe depression.

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
Montgomery Asberg Depression Rating Scale (MADRS) <= 10 24 hours	10 Participants	15 Participants	9 Participants
Montgomery Asberg Depression Rating Scale (MADRS) <= 10 7 days	7 Participants	9 Participants	4 Participants
Montgomery Asberg Depression Rating Scale (MADRS) <= 10 14 days	4 Participants	10 Participants	4 Participants

SECONDARY outcome

Timeframe: 7 days and 14 days

Population: Subjects early terminated after discharge

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

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
Hamilton Depression Rating Scale (HAM-D) Change From Baseline 7 days	-8.6 score on a scale Standard Deviation 7.61	-9.3 score on a scale Standard Deviation 8.09	-9.4 score on a scale Standard Deviation 7.07
Hamilton Depression Rating Scale (HAM-D) Change From Baseline 14 days	-6.1 score on a scale Standard Deviation 7.14	-8.7 score on a scale Standard Deviation 8.70	-8.1 score on a scale Standard Deviation 7.21

SECONDARY outcome

Timeframe: 24 hours, 7 days and 14 days

Population: Subjects early terminated from the study after discharge

Change from Baseline in GAD-7. The total score of the 7 items range from 0 to 21. Higher scores indicate more anxiety.

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
Generalized Anxiety Disorder (GAD-7) Change From Baseline 24 hours	-6.5 score on a scale Standard Error 0.84	-7.5 score on a scale Standard Error 0.83	-7.4 score on a scale Standard Error 0.85
Generalized Anxiety Disorder (GAD-7) Change From Baseline 7 days	-5.8 score on a scale Standard Error 0.89	-5.8 score on a scale Standard Error 0.85	-5.8 score on a scale Standard Error 0.89
Generalized Anxiety Disorder (GAD-7) Change From Baseline 14 days	-3.7 score on a scale Standard Error 0.87	-4.3 score on a scale Standard Error 0.84	-5.3 score on a scale Standard Error 0.88

SECONDARY outcome

Timeframe: 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.

Change from Baseline in CGI-S. The score ranged from 0 to 7. Higher scores indicate a more severe or worsening of condition.

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
Clinical Global Impression - Severity (CGI-S) Change From Baseline 24 hours	3.0 score on a scale Standard Error 0.23	3.0 score on a scale Standard Error 0.23	3.4 score on a scale Standard Error 0.23
Clinical Global Impression - Severity (CGI-S) Change From Baseline 7 days	3.4 score on a scale Standard Error 0.26	3.3 score on a scale Standard Error 0.25	3.5 score on a scale Standard Error 0.27
Clinical Global Impression - Severity (CGI-S) Change From Baseline 14 days	3.9 score on a scale Standard Error 0.29	3.3 score on a scale Standard Error 0.28	3.7 score on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: 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

This score ranges from 0 to 7. Higher scores indicate a more severe or worsening of the condition

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
Clinical Global Impression - Improvement (CGI-I) 24 hours	2.3 score on a scale Standard Error 0.20	2.2 score on a scale Standard Error 0.20	2.5 score on a scale Standard Error 0.20
Clinical Global Impression - Improvement (CGI-I) 7 days	2.8 score on a scale Standard Error 0.24	2.3 score on a scale Standard Error 0.23	2.6 score on a scale Standard Error 0.25
Clinical Global Impression - Improvement (CGI-I) 14 days	3.2 score on a scale Standard Error 0.25	2.5 score on a scale Standard Error 0.24	3.0 score on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: 24 hours, 7 days and 14 days

Population: Subjects early terminated from the study after discharge

Change from Baseline in QIDS-SR-16. Total score ranges from 0 to 42. Higher scores indicate more severe depression.

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline 24 hours	-9.6 score on a scale Standard Error 1.23	-10.7 score on a scale Standard Error 1.21	-10.5 score on a scale Standard Error 1.25
Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline 7 days	-8.4 score on a scale Standard Error 1.30	-10.1 score on a scale Standard Error 1.26	-9.4 score on a scale Standard Error 1.32
Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change From Baseline 14 days	-6.0 score on a scale Standard Error 1.42	-9.6 score on a scale Standard Error 1.38	-8.3 score on a scale Standard Error 1.46

SECONDARY outcome

Timeframe: 24 hours, 7 days and 14 days

Population: Subject early terminated from the study after discharge

Change from Baseline in EQ-5D-3L. The visual analogue scale ranges from 0 to 100. Higher scores indicate a better health state.

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=33 Participants Placebo Placebo: Concentrate for solution for infusion
European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline 14 days	8.2 score on a scale Standard Error 3.75	9.8 score on a scale Standard Error 3.58	11.0 score on a scale Standard Error 3.70
European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline 24 hours	13.9 score on a scale Standard Error 3.30	17.9 score on a scale Standard Error 3.20	14.9 score on a scale Standard Error 3.24
European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline 7 days	12.9 score on a scale Standard Error 3.46	14.1 score on a scale Standard Error 3.29	14.4 score on a scale Standard Error 3.40

SECONDARY outcome

Timeframe: 14 days

The number of participants in each treatment group with treatment-emergent adverse events categorized using MedDRA v24.0 or higher

Outcome measures

Outcome measures
Measure	PCN-101 30 mg n=33 Participants PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 Participants PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=34 Participants Placebo Placebo: Concentrate for solution for infusion
Treatment-emergent Adverse Events Summarized by Treatment Group, System Organ Class and Preferred Term	11 Participants	19 Participants	18 Participants

Adverse Events

PCN-101 30 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

PCN-101 60 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PCN-101 30 mg n=33 participants at risk PCN-101 30 mg PCN-101: Concentrate for solution for infusion	PCN-101 60 mg n=35 participants at risk PCN-101 60 mg PCN-101: Concentrate for solution for infusion	Placebo n=34 participants at risk Placebo Placebo: Concentrate for solution for infusion
Nervous system disorders Somnolence	12.1% 4/33 • 14 days	11.4% 4/35 • 14 days	26.5% 9/34 • 14 days
Nervous system disorders Dizziness	6.1% 2/33 • 14 days	20.0% 7/35 • 14 days	14.7% 5/34 • 14 days
Nervous system disorders Headache	9.1% 3/33 • 14 days	5.7% 2/35 • 14 days	8.8% 3/34 • 14 days
Nervous system disorders Dysarthria	0.00% 0/33 • 14 days	5.7% 2/35 • 14 days	0.00% 0/34 • 14 days
Nervous system disorders Paraesthesia	0.00% 0/33 • 14 days	5.7% 2/35 • 14 days	0.00% 0/34 • 14 days
Psychiatric disorders Derealisation	12.1% 4/33 • 14 days	8.6% 3/35 • 14 days	11.8% 4/34 • 14 days
Gastrointestinal disorders Nausea	0.00% 0/33 • 14 days	8.6% 3/35 • 14 days	2.9% 1/34 • 14 days
General disorders Feeling drunk	0.00% 0/33 • 14 days	5.7% 2/35 • 14 days	0.00% 0/34 • 14 days

Additional Information

Clinical Trials Group

Perception Neuroscience

Phone: +49 (0) 89 2153 9035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. If this is foreseen, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER