NCT04663321

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006)

Terminated Phase 2 Results posted Last updated 19 September 2024

What this trial tests

Phase 2 trial testing MK-1942 in Treatment Resistant Depression in 99 participants. Terminated before completion.

Timeline

20 May 2021

Primary endpoint
8 September 2023

8 September 2023

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	99
Start date	20 May 2021
Primary completion	8 September 2023
Estimated completion	8 September 2023
Sites	45 locations across United States

Drugs / interventions tested

• MK-1942 — full drug profile →
• Placebo

Conditions studied

• Treatment Resistant Depression — all drugs for Treatment Resistant Depression →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Treatment Resistant Depression. 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 From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 3 Primary · Baseline and Week 3

The change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score is presented. MADRS includes 10 participant-rated items, each scored on a scale from 0 (normal, no symptom) to 6 (symptoms of maximum severity) \[total scores range from 0 (normal/no symptom) to 60 (severe depression). Higher scores correspond to greater symptom severity, whereas a negative change from baseline score indicates improvement.

Group	Value	95% CI
MK-1942 Daily Dose Group	-8.1	-11.5 – -4.6
MK-1942 Intermittent Dose Group	-12.5	-17.3 – -7.7
Placebo	-11.4	-14.6 – -8.1

Change From Baseline in MADRS Total Score to Week 1 Primary · Baseline and Week 1

The change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score is presented. MADRS includes 10 participant-rated items, each scored on a scale from 0 (normal, no symptom) to 6 (symptoms of maximum severity) \[total scores range from 0 (normal/no symptom) to 60 (severe depression). Higher scores correspond to greater symptom severity, whereas a negative change from baseline score indicates improvement.

Group	Value	95% CI
MK-1942 Daily Dose Group	-5.2	-7.9 – -2.6
MK-1942 Intermittent Dose Group	-6.3	-10.0 – -2.6
Placebo	-8.1	-10.7 – -5.5

Number of Participants Who Experienced An Adverse Event (AE) Primary · Up to approximately 6 Weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Group	Value	95% CI
MK-1942 Daily Dose Group	29
MK-1942 Intermittent Dose Group	13
Placebo	27

Number of Participants Who Discontinued Study Treatment Due to an AE Primary · Up to approximately 4 Weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Group	Value	95% CI
MK-1942 Daily Dose Group	4
MK-1942 Intermittent Dose Group	3
Placebo	1

Change From Baseline in the Hamilton Depression Rating Scale (HAM-D17) Total Score to Week 3 Secondary · Baseline and Week 3

The HAM-D17 scale was used to evaluate the depressive symptoms experienced over the past week. The HAM-D17 is a 17-item participant-rated scale, with each item scored from 0 to 2 or 4 (depending on the question) reflective of severity (0 is absence of symptom and higher scores indicate greater symptom severity). The total score ranges from 0 (no apparent symptoms) to 52 (most severe symptoms). A negative change from baseline indicates symptom improvement, and vice versa.

Group	Value	95% CI
MK-1942 Daily Dose Group	-5.5	-7.7 – -3.3
MK-1942 Intermittent Dose Group	-8.2	-11.2 – -5.1
Placebo	-7.5	-9.6 – -5.5

Change From Baseline in the HAM-D17 Scale Total Score to Week 1 Secondary · Baseline and Week 1

The HAM-D17 scale was used to evaluate the depressive symptoms experienced over the past week. The HAM-D17 is a 17-item participant-rated scale, with each item scored from 0 to 2 or 4 (depending on the question) reflective of severity (0 is absence of symptom and higher scores indicate greater symptom severity). The total score ranges from 0 (no apparent symptoms) to 52 (most severe symptoms). A negative change from baseline indicates symptom improvement, and vice versa.

Group	Value	95% CI
MK-1942 Daily Dose Group	-4.1	-5.9 – -2.3
MK-1942 Intermittent Dose Group	-4.6	-7.2 – -2.1
Placebo	-5.8	-7.6 – -4.0

Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 3 Secondary · Baseline and Week 3

The CGI-S is rated on a 7-point scale using a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher score corresponds to greater symptom severity. A negative change score indicates improvement, and vice versa.

Group	Value	95% CI
MK-1942 Daily Dose Group	-0.9	-1.3 – -0.5
MK-1942 Intermittent Dose Group	-1.3	-1.9 – -0.7
Placebo	-1.1	-1.5 – -0.7

Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 1 Secondary · Baseline and Week 1

The CGI-S is rated on a 7-point scale using a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher score corresponds to greater symptom severity. A negative change score indicates improvement, and vice versa.

Group	Value	95% CI
MK-1942 Daily Dose Group	-0.4	-0.7 – -0.1
MK-1942 Intermittent Dose Group	-0.7	-1.1 – -0.3
Placebo	-0.8	-1.1 – -0.5

Mean Plasma Concentration of MK-1942 Plasma Concentration Secondary · Day 15: 12 (Daily Dose) or 72 (Intermittent Dose) hours postdose

The mean plasma concentration of MK-1942 10 mg given as a single or multiple dose regimen was determined.

Group	Value	95% CI
MK-1942 Daily Dose Group	130	± 69.3
MK-1942 Intermittent Dose Group	9.43	± 9.13

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to ~6 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MK-1942 Daily Dose Group

Serious: 0/40 (0%)

Deaths: 0/40

MK-1942 Intermittent Dose Group

Serious: 0/19 (0%)

Deaths: 0/19

Placebo

Serious: 1/40 (3%)

Deaths: 0/40

Serious adverse events (1 terms)

Reaction	System	MK-1942 Daily Dose Group	MK-1942 Intermittent Dose …	Placebo
Loss of consciousness	Nervous system disorders	—	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	MK-1942 Daily Dose Group	MK-1942 Intermittent Dose …	Placebo
Dizziness	Nervous system disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—
Somnolence	Nervous system disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Vision blurred	Eye disorders	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—
Disease progression	General disorders	—	—	—
Influenza	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Corneal abrasion	Injury, poisoning and procedural complications	—	—	—
Essential tremor	Nervous system disorders	—	—	—
Alcohol withdrawal syndrome	Psychiatric disorders	—	—	—
Panic attack	Psychiatric disorders	—	—	—
Restlessness	Psychiatric disorders	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypotension	Vascular disorders	—	—	—

Most-reported serious reactions: Loss of consciousness.

Data from ClinicalTrials.gov NCT04663321 adverse events section.

Sponsor's own description

The main purpose of this study is to assess the efficacy and safety of daily and intermittent dosing of MK-1942 compared to placebo among participants with Treatment-Resistant Depression (TRD) on a stable course of antidepressant therapy. The dual primary hypotheses of the study are that the daily MK-1942 treatment or intermittent MK-1942 treatment are superior to placebo in reducing Montgomery-Asberg Depression Rating Scale (MADRS) score.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.