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MK-8189 for Schizophrenia
Verified Trial
Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet the diagnostic criteria for schizophrenia according to the DSM-5
Have an illness duration for schizophrenia of at least 1 year
Must not have
Has a known history of (a) borderline personality disorder, anti-social personality disorder, or bipolar disorder (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease, or another form of dementia, or any chronic organic disease of the central nervous system (c) intellectual disability of a severity that would impact ability to participate in the study
Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~up to week 14
Awards & highlights
Study Summary
This trial is testing if MK-8189 is an effective and safe treatment for schizophrenia according to DSM-5 criteria. The primary hypotheses are that MK-8189 24mg and 16mg are superior to placebo in reducing PANSS total score.
Who is the study for?
This trial is for adults with an acute episode of schizophrenia, diagnosed per DSM-5 criteria. Participants must be moderately ill or worse and have had schizophrenia for at least a year. It excludes those with other psychotic disorders, certain personality disorders, brain injuries affecting cognition, Alzheimer's, other dementias, severe central nervous system diseases, or intellectual disabilities.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of MK-8189 in doses of 8 mg (limited to early enrollees), 16 mg, and 24 mg against placebos. The goal is to see if MK-8189 can better reduce symptoms measured by the PANSS score after six weeks compared to placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, typical antipsychotic medication side effects may include drowsiness, weight gain, dry mouth, restlessness and sometimes more serious conditions like movement disorders or metabolic changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia.
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I have been diagnosed with schizophrenia for at least one year.
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You have a score of 4 or higher on the CGI-S scale, which means you are moderately ill.
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I am between 18 and 51 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a mental health condition or brain disorder that would affect my study participation.
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You have a mental illness other than schizophrenia or behavioral problems caused by substance abuse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ~up to week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~up to week 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
Number of participants who discontinue study treatment due to an AE
Number of participants who experience one or more adverse events (AEs)
Secondary outcome measures
Change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
Change from baseline in PANSS positive subscale (PSS) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
Change from baseline in weight at Week 12: MK-8189 24 mg, MK-8189 16 mg, or risperidone
+1 moreSide effects data
From 2018 Phase 2 trial • 224 Patients • NCT0305533818%
Akathisia
16%
Nausea
16%
Headache
9%
Dystonia
8%
Diarrhoea
8%
Vomiting
8%
Sedation
8%
Anxiety
7%
Decreased appetite
7%
Somnolence
7%
Insomnia
6%
Dyspepsia
3%
Dizziness
2%
Weight increased
2%
Fatigue
1%
Agitation
1%
Lethargy
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-8189
Risperidone
Placebo
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Placebo to MK-8189 (Acute) - MK-8189 24 mg (Extension)Experimental Treatment3 Interventions
Participants will be treated for a total of 12 weeks. Participants will receive MK-8189-matching placebo QD in the acute treatment period from Week 1-6 followed by MK-8189 24 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.
Group II: MK-8189 8 mg (Acute) - MK-8189 8 mg (Extension)Experimental Treatment2 Interventions
Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 8 mg once daily (QD) in the acute treatment period from Week 1-6 followed by MK-8189 8 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12. Enrollment of participants in the MK-8189 8 mg arm was closed with Amendment 4. Participants enrolled before Amendment 4 that have been assigned to 8 mg MK-8189 will remain on 8 mg MK-8189 per protocol.
Group III: MK-8189 24 mg (Acute) - MK-8189 24 mg (Extension)Experimental Treatment2 Interventions
Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 24 mg QD in the acute treatment period from Week 1-6 followed by MK-8189 24 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.
Group IV: MK-8189 16 mg (Acute) - MK-8189 16 mg (Extension)Experimental Treatment2 Interventions
Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 16 mg QD in the acute treatment period from Week 1-6 followed by MK-8189 16 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.
Group V: Risperidone 6 mg (Acute) - Risperidone 6 mg (Extension)Active Control2 Interventions
Participants will be treated for a total of 12 weeks. Participants will receive risperidone 6 mg QD in the acute treatment period from Week 1-6 followed by risperidone 6 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive MK-8189-matching placebo QD from Week 1-12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo to MK-8189
2023
Completed Phase 1
~20
MK-8189
2020
Completed Phase 2
~640
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,635 Total Patients Enrolled
34 Trials studying Schizophrenia
8,459 Patients Enrolled for Schizophrenia
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,171 Total Patients Enrolled
23 Trials studying Schizophrenia
2,186 Patients Enrolled for Schizophrenia
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,244 Total Patients Enrolled
28 Trials studying Schizophrenia
3,838 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mental illness other than schizophrenia or behavioral problems caused by substance abuse.I have been diagnosed with schizophrenia for at least one year.I do not have a mental health condition or brain disorder that would affect my study participation.I am between 18 and 51 years old.I have been diagnosed with schizophrenia.You have a score of 4 or higher on the CGI-S scale, which means you are moderately ill.
Research Study Groups:
This trial has the following groups:- Group 1: MK-8189 8 mg (Acute) - MK-8189 8 mg (Extension)
- Group 2: MK-8189 16 mg (Acute) - MK-8189 16 mg (Extension)
- Group 3: MK-8189 24 mg (Acute) - MK-8189 24 mg (Extension)
- Group 4: Risperidone 6 mg (Acute) - Risperidone 6 mg (Extension)
- Group 5: Placebo to MK-8189 (Acute) - MK-8189 24 mg (Extension)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must individuals meet to qualify for participation in this trial?
"To be selected for the trial, schizophrenic patients aged between 18 and 50 must apply. The total number of participants accepted is 576."
Answered by AI
Could you outline the number of medical centers conducting this research in this urban area?
"Several 24 testing sites are involved in this trial, including Alexian Center for Psychiatric Research (Site 1000) located in Hoffman Estates, Nevada, Altea Research Institute (Site 1012) from Las Vegas, North carolina and Pillar Clinical Research LLC ( Site 1038 ) based in Charlotte, California."
Answered by AI
Does MK-8189 pose a health hazard to those who take it?
"MK-8189 earned a score of 2 due to limited clinical data that suggests it is safe, yet no evidence has been produced showing its efficacy."
Answered by AI
What goals have been set for the outcomes of this experiment?
"Data supplied by Merck Sharp & Dohme LLC confirms that the primary outcome for this trial, assessed over a 12 week period, is the number of participants who experience one or more adverse events (AEs). Additionally, secondary outcomes such as changes in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6: MK-8189 24 mg and 16 mg versus placebo; PANSS positive subscale (PSS) score at Week 6: MK 8189 24 mg and 16 mg compared to placebo; and PANSS total score at Week 6: MK-8189 8mg vs."
Answered by AI
Are there any prior experiments with MK-8189 that have been conducted?
"MK-8189 was initially investigated in 2004 at Psychiatric Service, Tel-Aviv Sourasky Medical Center. Consequently, there have been 209 finalized trials and 17 active studies are underway across Hoffman Estates, Nevada."
Answered by AI
Is recruitment for this experiment currently ongoing?
"According to the details on clinicaltrials.gov, this medical trial is currently enrolling participants. It was first posted in December 2020 and underwent its most recent update in November of 2022."
Answered by AI
How many participants are enrolled in this experimental endeavor?
"In order to complete the trial, Merck Sharp & Dohme LLC needs to recruit 576 candidates that meet their eligibility criteria. Research is taking place at Alexian Center for Psychiatric Research ( Site 1000) in Hoffman Estates and Altea Research Institute (Site 1012) in Las Vegas."
Answered by AI
Is the age limit of this trial restricted to only those over 25?
"In order to be eligible for this medical trial, applicants must fall between the ages of 18 and 50. Those aged under 18 have access to a seperate pool of 50 trials while those over 65 are able to choose from 170 different studies."
Answered by AI
To what conditions is MK-8189 typically administered?
"MK-8189 is widely prescribed to treat acute coryza, but has also been used in the management of autistic disorder, bipolar disorder and irritability."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
California
What site did they apply to?
CITRIALS ( Site 1010)
Premier Clinical Research Institute ( Site 1049)
Community Clinical Research ( Site 1057)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What questions have other patients asked about this trial?
Do I have to sleep there?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
Because I have schizophrenic. My “schizophrenia” makes me suicidal. I was diagnosed in January this year 2023. It is not improving.
PatientReceived no prior treatments
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