Efficacy and Safety of MK-1942 When Added to Stable Antid... | NCT04663321

ID	Type	Description	Link
MK-1942-006	Other Identifier	MSD

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MK-1942 Daily Dose Group	Experimental	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.	Drug: MK-1942 Drug: Placebo
MK-1942 Intermittent Dose Group	Experimental	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.	Drug: MK-1942 Drug: Placebo
Placebo	Placebo Comparator	Participants receive a dose-matched placebo BID, orally, for 4 weeks. Participants receive matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK-1942	Drug	MK-1942 (5 mg or 10 mg capsules) titrated from 5 mg to 20 mg dose BID or 10 mg BIW over 4 weeks.	MK-1942 Daily Dose Group MK-1942 Intermittent Dose Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to 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.](streamdown:incomplete-link)	Baseline and Week 3
Change From Baseline in MADRS Total Score to 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.](streamdown:incomplete-link)	Baseline and Week 1
Number of Participants Who Experienced An Adverse Event (AE)	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.	Up to approximately 6 Weeks
Number of Participants Who Discontinued Study Treatment Due to an AE	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.	Up to approximately 4 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Hamilton Depression Rating Scale (HAM-D17) Total Score to 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets the diagnostic criteria for moderate-to-severe major depressive disorder (MDD) without psychotic features according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria at Visit 1 (Screening)
Is currently experiencing an episode of moderate-to-severe MDD
Had an inadequate response to 1 to 4 different courses of antidepressant therapy for the current episode of moderate-to-severe MDD
Has been on a stable course of antidepressant therapy for ≥4 weeks before Visit 1 (Screening)
Has not initiated psychotherapy for depressive symptoms in the last 3 months before Visit 1 (Screening) and agrees not to initiate a new psychotherapy for depressive symptoms or to modify their current regimen of psychotherapy for depressive symptoms from Visit 1 (Screening) to Visit 9 (Post-dose Follow-up Visit)
Male participants are eligible if they agree to the following during the intervention period and for at least 7 days after last dose of study intervention: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or agrees to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
A female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP) or a WOCBP who is not pregnant, breastfeeding, or within 3 months from postpartum. WOCBP should use contraceptive methods that are highly effective as per the study specifications or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, have a negative pregnancy test at screening, immediately prior to the first dosing event, and at regular intervals during the study period, and abstain from breastfeeding during the study intervention period and for at least 7 days after last study intervention
Has a reliable contact person

Exclusion Criteria:

Has an ongoing episode of MDD that started more than 2 years before Visit 1 (Screening)
Has a current or prior history of one or more of the following: a) diagnosis of a psychotic disorder b) chronic convulsive disorder, except febrile seizures during childhood c) neurodegenerative disorder, traumatic brain injury causing ongoing cognitive difficulties, or any chronic organic disease of the central nervous system d) intellectual disability of a severity that would affect the ability of the participant to participate in the study e) bipolar and related disorders, MDD with psychosis f) MDD with mixed features g) posttraumatic stress disorder if not in remission for at least 5 years before Visit 1 (Screening) h) obsessive-compulsive disorder i) autism spectrum disorder
Meets criteria for substance abuse or dependence disorder currently or within the 12 months before Visit 1 (Screening)
Has a known allergy or intolerance to the active or inert ingredients in MK-1942
Has a history of malignancy ≤3 years before Visit 1 (Screening) except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Has a Body Mass Index (BMI) >40 kg/m2
Has HIV or nonstable hypothyroidism, diabetes, cardiovascular disease, or respiratory disease
Failed to adequately respond to treatment with ketamine or esketamine for the current or a prior episode of MDD
Previously received electroconvulsive therapy within the past 10 years, deep brain stimulation, or vagal nerve stimulation for treatment of depression
Is imminent risk for self harm or harm to others
Is currently participating in or has previously participated in an interventional clinical study within the 2 months before Visit 1 (Screening), or has participated in >4 interventional clinical studies within the 2 years before Visit 1 (Screening)
Has known renal disease or is experiencing renal insufficiency
Routinely consumes >3 alcoholic drinks per day. One standard drink is defined as any beverage containing 14 gram (g) of pure alcohol
Requires use of a language interpreter to participate in the study
Had major surgery or donated or lost >1 unit of blood within the 4 weeks before Visit 1 (Screening)
Is pregnant or is currently breastfeeding or plans to breastfeed during the course of the study
Is a woman with <12 months of amenorrhea and is receiving hormone replacement therapy (HRT) or an estrogen-based contraceptive
Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham - School of Medicine-Psychiatry ( Site 1073)		Birmingham	Alabama	35233	United States

PubMed Identifier	Type	Citation	Retractions
41854661	Result	Merola A, Mukai Y, Bueters T, Ceesay P, Dupre N, Furtek C, Sanacora G, Thase ME, Targum SD, Smith SM, Egan MF. Phase 2 Clinical Trial of MK-1942, a Negative Allosteric Modulator of Metabotropic Glutamate Receptor 2, for Treatment-Resistant Depression. J Clin Psychopharmacol. 2026 Jul-Aug 01;46(4):427-432. doi: 10.1097/JCP.0000000000002171. Epub 2026 Mar 19.

Label	URL
Merck Clinical Trials Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 28, 2022

Arm/Group Information

ID	Title	Description
BG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
BG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
BG002	Placebo	Participants receive a dose-matched placebo BID, orally, for 4 weeks. Participants receive matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to 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.](streamdown:incomplete-link)

All randomized participants who received ≥1 dose of study intervention, have ≥1 post-treatment and -randomization endpoint observation, and have baseline data available are included.

Posted

Least Squares Mean

95% Confidence Interval

Units on a scale

Baseline and Week 3

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG002	Placebo	Participants receive a dose-matched placebo BID, orally, for 4 weeks. Participants receive matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.

Units	Counts
Participants	OG00030 OG00116 OG00237

Title

Denominators

Categories

Title	Measurements
	OG000-8.1(-11.5 to -4.6) OG001-12.5(-17.3 to -7.7) OG002-11.4(-14.6 to -8.1)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		ANCOVA		0.168		LS Mean Difference	3.3			2-Sided	95	-1.4	8.0					Superiority	Difference in LS Means
OG001 OG002		ANCOVA		0.697

Primary

Change From Baseline in MADRS Total Score to Week 1

All randomized participants who received ≥1 dose of study intervention, have ≥1 post-treatment and -randomization endpoint observation, and have baseline data available are included.

Posted

Least Squares Mean

95% Confidence Interval

Units on a scale

Baseline and Week 1

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.

Primary

Number of Participants Who Experienced An Adverse Event (AE)

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.

All randomized participants who received ≥11 dose of study intervention are included.

Posted

Count of Participants

Participants

Up to approximately 6 Weeks

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG002	Placebo

Primary

Number of Participants Who Discontinued Study Treatment Due to an AE

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.

All randomized participants who received ≥11 dose of study intervention are included.

Posted

Count of Participants

Participants

Up to approximately 4 Weeks

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG002	Placebo

Secondary

Change From Baseline in the Hamilton Depression Rating Scale (HAM-D17) Total Score to 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.

All randomized participants who received ≥1 dose of study intervention, have ≥1 post-treatment and -randomization endpoint observation, and have baseline data available are included.

Posted

Least Squares Mean

95% Confidence Interval

Units on a scale

Baseline and Week 3

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.

Secondary

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

All randomized participants who received ≥1 dose of study intervention, have ≥1 post-treatment and -randomization endpoint observation, and have baseline data available are included.

Posted

Least Squares Mean

95% Confidence Interval

Units on a scale

Baseline and Week 1

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.

Secondary

Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to 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.

All randomized participants who received ≥1 dose of study intervention, have ≥1 post-treatment and -randomization endpoint observation, and have baseline data available are included.

Posted

Least Squares Mean

95% Confidence Interval

Units on a scale

Baseline and Week 3

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.

Secondary

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

All randomized participants who received ≥1 dose of study intervention, have ≥1 post-treatment and -randomization endpoint observation, and have baseline data available are included.

Posted

Least Squares Mean

95% Confidence Interval

Units on a scale

Baseline and Week 1

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.

Secondary

Mean Plasma Concentration of MK-1942 Plasma Concentration

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

A subset of MK-1942-treated participants who complied with the protocol sufficiently to ensure that generated data are likely to exhibit the effects of treatment are included.

Posted

Mean

Standard Deviation

Day 15: 12 (Daily Dose) or 72 (Intermittent Dose) hours postdose

ID	Title	Description
OG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
OG002	Placebo

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MK-1942 Daily Dose Group	Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.	40	0	40	22	40
EG001	MK-1942 Intermittent Dose Group	Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.	19	0	19	13	19
EG002	Placebo	Participants receive a dose-matched placebo BID, orally, for 4 weeks. Participants receive matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.	40	1	40	20	40

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0022 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected40 at risk EG0012 affected19 at risk EG0023 affected40 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0007 affected40 at risk EG0013 affected19 at risk EG0026 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected40 at risk EG0011 affected19 at risk EG0022 affected40 at risk
Disease progression	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0003 affected40 at risk EG0010 affected19 at risk EG0025 affected40 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 affected40 at risk EG0011 affected19 at risk EG0021 affected40 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00010 affected40 at risk EG0016 affected19 at risk EG0023 affected40 at risk
Essential tremor	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0005 affected40 at risk EG0011 affected19 at risk EG0027 affected40 at risk
Somnolence	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected19 at risk EG0024 affected40 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected40 at risk EG0010 affected19 at risk EG0021 affected40 at risk
Panic attack	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Restlessness	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected40 at risk

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders