NCT03446846

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

Completed Phase 2 Results posted Last updated 17 December 2020

What this trial tests

Phase 2 trial testing MIN-117 5.0 mg in Major Depressive Disorder in 360 participants. Completed in 13 December 2019.

Timeline

30 March 2018

Primary endpoint
21 November 2019

13 December 2019

Quick facts

Lead sponsor	Minerva Neurosciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	360
Start date	30 March 2018
Primary completion	21 November 2019
Estimated completion	13 December 2019
Sites	47 locations across Georgia, Finland, Ukraine, Moldova, Poland, Bulgaria, United States

Drugs / interventions tested

• MIN-117 5.0 mg — full drug profile →
• MIN-117 2.5 mg — full drug profile →
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Minerva Neurosciences — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Primary · Week 6

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 re

Group	Value	95% CI
5.0 mg MIN-117	-12	± 9.2
2.5 mg MIN-117	-12	± 9.2
Placebo	-12	± 9.2

Change in Hamilton Anxiety Scale (HAM-A) Secondary · Change from Baseline to the end of Week 6

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 severi

Group	Value	95% CI
5.0 mg MIN-117	-12	± 8.0
2.5 mg MIN-117	-11	± 9.1
Placebo	-11	± 8.5

Change in Clinical Global Impression of Severity Scale (CGI-S) Secondary · Change from Baseline to Week 6

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 parti

Group	Value	95% CI
5.0 mg MIN-117	-1	± 1.3
2.5 mg MIN-117	-1	± 1.1
Placebo	-1	± 1.2

Change in Clinical Global Impression of Improvement Scale (CGI-I) at Week 6 Secondary · Week 6

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

Group	Value	95% CI
5.0 mg MIN-117	3	± 1.0
2.5 mg MIN-117	3	± 1.2
Placebo	3	± 1.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately up to 11 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

5.0 mg MIN-117

Serious: 0/91 (0%)

Deaths: 0/91

2.5 mg MIN-117

Serious: 1/92 (1%)

Deaths: 0/92

Placebo

Serious: 0/177 (0%)

Deaths: 0/177

Serious adverse events (3 terms)

Reaction	System	5.0 mg MIN-117	2.5 mg MIN-117	Placebo
Feeling guilty	Psychiatric disorders	—	—	—
Major depression	Psychiatric disorders	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	5.0 mg MIN-117	2.5 mg MIN-117	Placebo
Headache	Nervous system disorders	—	—	—

Most-reported serious reactions: Feeling guilty, Major depression, Suicidal ideation.

Data from ClinicalTrials.gov NCT03446846 adverse events section.

Sponsor's own description

MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of MIN-117 in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, including placebo, 2.5 mg MIN-117, or 5.0 mg MIN-117, in a 2:1:1 ratio.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry.
   Sakurai H, Yonezawa K, Tani H, Mimura M, et al · · 2022 · cited 21× · PMID 35045580 · DOI 10.1055/a-1714-9097
2. Investigational Drugs for the Treatment of Depression (Part 1): Monoaminergic, Orexinergic, GABA-Ergic, and Anti-Inflammatory Agents.
   Vasiliu O. · · 2022 · cited 20× · PMID 35774601 · DOI 10.3389/fphar.2022.884143