Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder (NCT NCT03446846)

Last Updated: 2020-12-17

Results Overview

The Montgomery-Asberg Depression Rating Scale (MADRS) is a validated, physician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe conditions. MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. The test exhibits high inter-rater reliability and its capacity to differentiate between responders and nonresponders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

360 participants

Primary outcome timeframe

Week 6

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	5.0 mg MIN-117 MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose orally once daily.	2.5 mg MIN-117 MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose orally once daily.	Placebo Placebo taken as two Placebo capsules as a single dose orally once daily.
Overall Study STARTED	90	92	178
Overall Study COMPLETED	83	87	162
Overall Study NOT COMPLETED	7	5	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5.0 mg MIN-117 n=91 Participants MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose orally once daily.	2.5 mg MIN-117 n=92 Participants MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose orally once daily.	Placebo n=177 Participants Placebo taken as two Placebo capsules as a single dose orally once daily.	Total n=360 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants	92 Participants n=7 Participants	177 Participants n=5 Participants	360 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	48 years STANDARD_DEVIATION 11.5 • n=5 Participants	47 years STANDARD_DEVIATION 12.7 • n=7 Participants	47 years STANDARD_DEVIATION 12.5 • n=5 Participants	48 years STANDARD_DEVIATION 12.3 • n=4 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	60 Participants n=7 Participants	136 Participants n=5 Participants	258 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	32 Participants n=7 Participants	41 Participants n=5 Participants	102 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	87 Participants n=7 Participants	165 Participants n=5 Participants	337 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 6

Population: ITT population: all randomized patients who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	5.0 mg MIN-117 n=70 Participants MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose once daily.	2.5 mg MIN-117 n=76 Participants MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily.	Placebo n=149 Participants Placebo taken as two Placebo capsules as a single dose once daily.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-12 score on a scale Standard Deviation 9.2	-12 score on a scale Standard Deviation 9.2	-12 score on a scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: Change from Baseline to the end of Week 6

Population: ITT population: all randomized patients who received at least 1 dose of study drug.

Hamilton Anxiety Scale (HAM-A) measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. The subject is asked to rate the gravity of each item using a 5-level scale - from 0 to 4, where 0 being not present and 4 being severe - and afterwards, the results are collated and tabulated to determine the severity of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-25 mild to moderate severity, 25-30 moderate to severe, and \>30 indicates very severe. To implement the HAM-A, the acting clinician proceeds through the 14 items, evaluating each criterion independently in form of the five-point scale described above.

Outcome measures

Outcome measures
Measure	5.0 mg MIN-117 n=70 Participants MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose once daily.	2.5 mg MIN-117 n=76 Participants MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily.	Placebo n=149 Participants Placebo taken as two Placebo capsules as a single dose once daily.
Change in Hamilton Anxiety Scale (HAM-A)	-12 score on a scale Standard Deviation 8.0	-11 score on a scale Standard Deviation 9.1	-11 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Change from Baseline to Week 6

Population: ITT population: all randomized patients who received at least 1 dose of study drug.

The Clinical Global Impression of Severity (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" which is rated on the following scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The CGI-S will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function.

Outcome measures

Outcome measures
Measure	5.0 mg MIN-117 n=70 Participants MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose once daily.	2.5 mg MIN-117 n=76 Participants MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily.	Placebo n=149 Participants Placebo taken as two Placebo capsules as a single dose once daily.
Change in Clinical Global Impression of Severity Scale (CGI-S)	-1 score on a scale Standard Deviation 1.3	-1 score on a scale Standard Deviation 1.1	-1 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Week 6

Population: ITT population: all randomized patients who received at least 1 dose of study drug.

The Clinical Global Impression of Improvement Scale (CGI-I) will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-I consists of a 7-point scale that evaluates the change from initiation of treatment similar to the Clinical Global Impression of Severity Scale (CGI-S). This 7-point scale requires the clinician to assess how much the subject's illness has improved or worsened relative to a Baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

Outcome measures

Outcome measures
Measure	5.0 mg MIN-117 n=70 Participants MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose once daily.	2.5 mg MIN-117 n=76 Participants MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily.	Placebo n=149 Participants Placebo taken as two Placebo capsules as a single dose once daily.
Change in Clinical Global Impression of Improvement Scale (CGI-I) at Week 6	3 score on a scale Standard Deviation 1.0	3 score on a scale Standard Deviation 1.2	3 score on a scale Standard Deviation 1.1

Adverse Events

5.0 mg MIN-117

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

2.5 mg MIN-117

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5.0 mg MIN-117 n=91 participants at risk MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose orally once daily.	2.5 mg MIN-117 n=92 participants at risk MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose orally once daily.	Placebo n=177 participants at risk Placebo taken as two Placebo capsules as a single dose orally once daily.
Psychiatric disorders Feeling guilty	0.00% 0/91 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.	1.1% 1/92 • Number of events 1 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.	0.00% 0/177 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.
Psychiatric disorders Major depression	0.00% 0/91 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.	1.1% 1/92 • Number of events 1 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.	0.00% 0/177 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.
Psychiatric disorders Suicidal ideation	0.00% 0/91 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.	1.1% 1/92 • Number of events 1 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.	0.00% 0/177 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.

Other adverse events

Other adverse events
Measure	5.0 mg MIN-117 n=91 participants at risk MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose orally once daily.	2.5 mg MIN-117 n=92 participants at risk MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose orally once daily.	Placebo n=177 participants at risk Placebo taken as two Placebo capsules as a single dose orally once daily.
Nervous system disorders Headache	12.1% 11/91 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.	12.0% 11/92 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.	7.3% 13/177 • Approximately up to 11 weeks The Safety Population is the population of all patients who receive at least 1 dose of study treatment. Patients in this population will be analyzed according to the treatment they received, regardless of which treatment they were randomly assigned. All safety and tolerability analyses will be based on this population and treatment assignment. Treatment-emergent adverse events were those that were reported on or after the initiation of the study drug.

Additional Information

Head of Research & Development

Minerva Neurosciences, Inc.

Phone: 617.600.7375

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI agrees not to independently publish the results before the publication of the multi-center results. PI agrees to submit their proposed publication or presentation to Sponsor at least 2 months prior to disclosure. Sponsor may comment and may require deletion of trade secrets and proprietary or confidential information, other than study data.
Publication restrictions are in place

Restriction type: OTHER