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SchizophreniaPhase 2NCT04624243

Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008)

A Phase 2 study testing Elpipodect and Risperidone in people with Schizophrenia, run by Merck Sharp & Dohme LLC at 121 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to evaluate the efficacy and safety of elpipodect at a range of doses (8 mg, 16 mg, and 24 mg once daily [QD]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia
What is being tested?
Elpipodect and Risperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
499 participants
Where
121 sitesin 12 countries
Study dates
15 Dec 2020to 21 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The main inclusion criteria include, but are not limited to the following:
  • Meet the diagnostic criteria for schizophrenia according to the DSM-5
  • Have an illness duration for schizophrenia of at least 1 year
  • Be confirmed to be experiencing an acute episode of schizophrenia as evidenced by ALL of the following: (a) onset of the current acute episode is ≤6 weeks before screening (b) current symptoms represent a marked and substantial worsening compared with the participant's usual symptomatic state prior to the current acute episode, and are associated with diminished functional ability (c) in need of increased psychiatric attention to treat worsening acute episode symptoms
  • Have a CGI-S score of ≥4 (moderately ill) at screening and baseline
  • Have an identified responsible person referred to as the "external contact person" who has agreed to provide information about the participant's location if needed during outpatient portion of the study. The site personnel must consider this identified responsible person a reliable contact person, and the contact person must have regular contact with the participant (defined at screening as direct contact no fewer than 3 times per week), and with the expectation that this frequency of contact would continue (either in person or via other contact method), throughout duration of the study, including the follow-up period)

Who cannot join

  • The main exclusion criteria include, but are not limited to the following:
  • Has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment
  • Meets criteria for moderate to severe substance use disorder within past 6 months prior to screening (excluding those related to caffeine or nicotine)
  • Has a known history of the following: (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
  • Is or was under involuntary commitment for the acute episode, because the participant is considered a danger to themselves or others
  • Has a history of treatment resistance exhibited by any of the following: (a) no or minimal response to at least 2 periods of treatment lasting 6 weeks or longer, with antipsychotic agents at the maximally tolerated dose. Participants who have responded to antipsychotics only when paired with clozapine are considered treatment-resistant (b) history of electroconvulsive therapy (ECT) treatment for treatment-resistant schizophrenia within the past 6 months (c) past or current use of clozapine as single or adjunctive therapy for schizophrenia within the past 3 months
  • Is currently participating in or has participated in another clinical study and received an experimental or investigational drug agent within 3 months prior to screening visit of this current study and has participated in no more than 2 studies in the past 2 years

Trial locations and contacts

121 sites in 12 countries.

121 sites in 12 countries

United States35 sites

  • Atlanta Center For Medical Research ( Site 1022)

    Atlanta, Georgia, 30331

  • Community Clinical Research ( Site 1057)

    Austin, Texas, 78754

  • CITRIALS ( Site 1010)

    Bellflower, California, 90706

  • Pillar Clinical Research ( Site 1047)

    Bentonville, Arkansas, 72712-3873

  • Massachusetts General Hospital ( Site 1035)

    Boston, Massachusetts, 02114

  • New Hope Clinical Research ( Site 1050)

    Charlotte, North Carolina, 28211

  • Ascension Saint Elizabeth ( Site 1000)

    Chicago, Illinois, 60622

  • Uptown Research Institute ( Site 1052)

    Chicago, Illinois, 60640

  • Pillar Clinical Research, LLC ( Site 1038)

    Chicago, Illinois, 60641

  • ProScience Research Group ( Site 1046)

    Culver City, California, 90230

  • Midwest Clinical Research ( Site 1059)

    Dayton, Ohio, 45417

  • Midwest Clinical Research Center ( Site 1033)

    Dayton, Ohio, 45417

  • CenExel iResearch, LLC ( Site 1039)

    Decatur, Georgia, 30030

  • CBH Health ( Site 1044)

    Gaithersburg, Maryland, 20877

  • Collaborative Neuroscience Research, LLC ( Site 1041)

    Garden Grove, California, 92845

  • Behavioral Research Specialists, LLC ( Site 1032)

    Glendale, California, 91206

  • Behavioral Clinical Research ( Site 1058)

    Hollywood, Florida, 33021

  • Research Centers of America ( Hollywood )-Central Nervous System (CNS) ( Site 1065)

    Hollywood, Florida, 33024

  • Altea Research Institute ( Site 1012)

    Las Vegas, Nevada, 89102

  • Woodland International Research Group, LLC ( Site 1002)

    Little Rock, Arkansas, 72211

  • Hassman Research Institute Marlton Site ( Site 1040)

    Marlton, New Jersey, 08053

  • Premier Clinical Research Institute ( Site 1049)

    Miami, Florida, 33122

  • Behavioral Clinical Research , Inc ( Site 1013)

    Miami Lakes, Florida, 33016

  • Neuro-Behavioral Clinical Research ( Site 1055)

    North Canton, Ohio, 44720

  • Fort Lauderdale Behavioral Health Center ( Site 1028)

    Oakland Park, Florida, 33334

  • Pillar Clinical Research, LLC ( Site 1004)

    Richardson, Texas, 75080

  • CITRIALS ( Site 1016)

    Riverside, California, 92506

  • Woodland Research Northwest, LLC ( Site 1036)

    Rogers, Arkansas, 72758

  • Artemis Institute for Clinical Research ( Site 1019)

    San Diego, California, 92103

  • California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) ( Site 103

    San Diego, California, 92123

  • Schuster Medical Research Institute ( Site 1023)

    Sherman Oaks, California, 91403

  • Benchmark Research ( Site 1054)

    Shreveport, Louisiana, 71101

  • Arch Clinical Trials ( Site 1048)

    St Louis, Missouri, 63141

  • Richmond Behavioral Associates ( Site 1064)

    Staten Island, New York, 10314

  • Health Synergy Clinical Research ( Site 1051)

    Stuart, Florida, 34997

Other trials in United States

Japan22 sites

  • Soushu Hospital ( Site 2008)

    Atsugi, Kanagawa, 243-0201

  • Chiba University Hospital ( Site 2024)

    Chiba, 260-8677

  • Inokuchi Noma Hospital ( Site 2030)

    Fukuoka, 815-0074

  • Kuramitsu Hospital ( Site 2014)

    Fukuoka, 819-0037

  • Ongata Hospital ( Site 2007)

    Hachiōji, Tokyo, 192-0153

  • Tanzawa Hospital ( Site 2037)

    Hadano, Kanagawa, 259-1304

  • Kohnodai Hospital, National Center for Global Health and Medicine ( Site 2005)

    Ichikawa, Chiba, 272-8516

  • National Hospital Organization Hizen Psychiatric Medical Center ( Site 2017)

    Kanzaki-gun, Saga-ken, 8420192

  • Rainbow and Sea Hospital ( Site 2016)

    Karatsu, Saga-ken, 847-0031

  • Nishigahara Hospital ( Site 2042)

    Kita-ku, Tokyo, 114-0024

  • Wakato Hospital ( Site 2031)

    Kitakyushu, Fukuoka, 808-0139

  • National Center of Neurology and Psychiatry ( Site 2023)

    Kodaira, Tokyo, 187-8551

  • Komoro Kogen Hospital ( Site 2046)

    Komoro, Nagano, 384-8540

  • Yuge Hospital ( Site 2018)

    Kumamoto, 861-8002

  • National Hospital Organization Ryukyu Hospital ( Site 2019)

    Kunigamigun, Okinawa, 904-1201

  • Amekudai Hospital ( Site 2020)

    Naha, Okinawa, 900-0005

  • Shiranui Hospital ( Site 2043)

    Omuta, Fukuoka, 8360004

  • Seijin Hospital ( Site 2026)

    Tokyo, 121-8515

  • Narimasu Kosei Hospital ( Site 2006)

    Tokyo, 175-0091

  • Seimou Hospital ( Site 2004)

    Tomioka, Gunma, 3702455

  • Seishinkai Okehazama Hospital Fujita Kokoro Care Center ( Site 2011)

    Toyoake, Aichi-ken, 470-1168

  • Kanagawa Psychiatric Center ( Site 2035)

    Yokohama, Kanagawa, 233-0006

Other trials in Japan

Russia14 sites

  • Arkhangelsk Regional Psychiatric Clinical Hospital ( Site 6020)

    Arkhangelsk, Arkhangelskaya oblast, 163530

  • SGHI Leningrad Region Psyconeurology Dispensary ( Site 6017)

    Leningrad Region, Leningradskaya Oblast', 188820

  • Lipetsk Regional Psychoneurology Hospital ( Site 6021)

    Lipetsk, Lipetsk Oblast, 399083

  • Moscow Scientific Research Institute for Psychiatry ( Site 6013)

    Moscow, Moscow, 107076

  • Psychiatric Clinical Hospital 4 named after PB Gannushkin ( Site 6016)

    Moscow, Moscow, 107076

  • Psychiatric Clinical Hospital 4 named after PB Gannushkin-Psychiatric department 4 ( Site 6023)

    Moscow, Moscow, 107076

  • Central Moscow Regional Clinical Psychiatric Hospital ( Site 6018)

    Moscow, Moscow, 127083

  • Bekhterev Research Institute for Psychoneurology ( Site 6008)

    Saint Petersburg, Sankt-Peterburg, 192019

  • SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6000)

    Saint Petersburg, Sankt-Peterburg, 197341

  • SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6001)

    Saint Petersburg, Sankt-Peterburg, 197341

  • SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6002)

    Saint Petersburg, Sankt-Peterburg, 197341

  • Stavropol Region Psychiatric Hospital #2 ( Site 6005)

    Stavropol, Stavropol Kray, 357034

  • Federal State Scientific Institution Research Institute of Mental Health ( Site 6014)

    Tomsk, Tomsk Oblast, 634014

  • Yaroslavl Regional Clinical Psychiatry Hospital ( Site 6022)

    Yaroslavl, Yaroslavl Oblast, 150003

Other trials in Russia

Ukraine10 sites

  • Dnepropetrovsk Regional Clinical Hospital Mechnikov-Regional Centre of Psychosomatic Disorders base

    Dnipro, Dnipropetrovsk Oblast, 49005

  • CNE "Precarpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council"" (

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014

  • CNE of Kharkiv Reg. Council Reg. Clinical Psychiatric Hospital Nub 3 ( Site 7012)

    Kharkiv, Kharkiv Oblast, 61068

  • Institute of Neurology,Psychiatry and Narcology AMS Ukraine ( Site 7011)

    Kharkiv, Kharkiv Oblast, 61068

  • CNE. Kherson Regional Psychiatric Hospital ( Site 7004)

    Kherson, Kherson Oblast, 73488

  • Kyiv City Psychoneurological Hospital 2 ( Site 7008)

    Kyiv, Kyivska Oblast, 02192

  • CNE Clinical Hospital PSYCHIATRY of executive body of Kyiv City Council -Kyiv City State Admin ( Sit

    Kyiv, Kyivska Oblast, 04080

  • MNE of KRC-Regional psychiatric and narcological medical association ( Site 7005)

    Kyiv, Kyivska Oblast, 08631

  • CNE Cherkasy reg. psychiatric hospital of Cherkasy regional council ( Site 7009)

    Smila, Cherkasy Oblast, 20708

  • CNE "Vinnytsia Regional Clinical Psycho-neurological hospita-Mixed (men and women) department #2 ( S

    Vinnytsia, Vinnytsia Oblast, 21037

Other trials in Ukraine

Serbia9 sites

  • Clinical Center of Serbia ( Site 5101)

    Belgrade, Beograd, 11000

  • Clinical Center of Serbia ( Site 5107)

    Belgrade, Beograd, 11000

  • Institut za mentalno zdravlje ( Site 5105)

    Belgrade, Beograd, 11000

  • University Clinical Hospital Center "Dr. Dragisa Misovic - Dedinje" ( Site 5104)

    Belgrade, Beograd, 11000

  • Special Hospital for Psychiatric Diseases Kovin ( Site 5108)

    Kovin, Vojvodina, 26220

  • Special Hospital for Psychiatric Diseases Kovin ( Site 5109)

    Kovin, Vojvodina, 26220

  • Clinical Center Kragujevac ( Site 5100)

    Kragujevac, Sumadijski Okrug, 34000

  • Clinical Center Kragujevac ( Site 5102)

    Kragujevac, Sumadijski Okrug, 34000

  • Clinical Center Kragujevac ( Site 5106)

    Kragujevac, Sumadijski Okrug, 34000

Other trials in Serbia

Bulgaria6 sites

  • Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD ( Site 3002)

    Burgas, 8001

  • State Psychiatric Hospital - Kardzhali ( Site 3005)

    Kardzhali, 6600

  • State Psychiatric Hospital "Sv. Ivan Rilski", Novi Iskar ( Site 3001)

    Novi Iskar, Sofia, 1282

  • Mental Health Center - Ruse, EOOD ( Site 3003)

    Rousse, 7000

  • Center for Mental Health Prof. Nikola Shipkovenski Ltd ( Site 3000)

    Sofia, 1000

  • Mental Health Center - Veliko Tarnovo ( Site 3006)

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Romania6 sites

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0815)

    Bucharest, Bucharest, 041914

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0816)

    Bucharest, Bucharest, 041914

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0817)

    Bucharest, Bucharest, 041914

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0818)

    Bucharest, Bucharest, 041914

  • Institutul de Psihiatrie Socola ( Site 0810)

    Iași, Iaşi, 700282

  • Institutul de Psihiatrie Socola ( Site 0814)

    Iași, Iaşi, 700282

Other trials in Romania

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne ( Site 0902)

    Gdansk, Pomeranian Voivodeship, 80-211

  • Specjal. Psychiatryczny ZOZ w Lodzi, Szpital im. Babinskiego ( Site 0905)

    Lodz, Łódź Voivodeship, 91-229

  • Centrum Medyczne HCP ( Site 0913)

    Poznan, Greater Poland Voivodeship, 61-485

  • Klinika Psychiatryczna Wydzialu Nauki o Zdrowiu WUM ( Site 0900)

    Pruszków, Masovian Voivodeship, 05-802

  • Samodzielny Wojewódzki Zespół Publicznych Zakładów Psychiatrycznej Opieki Zdrowotnej w Warszawie ( S

    Warsaw, Masovian Voivodeship, 00-665

Other trials in Poland

Taiwan5 sites

  • China Medical University Hospital ( Site 9006)

    Taichung, 404

  • National Taiwan University Hospital ( Site 9001)

    Taipei, 100

  • Taipei City Hospital, Songde Branch ( Site 9004)

    Taipei, 110

  • Taipei Veterans General Hospital ( Site 9000)

    Taipei, 11217

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 9002)

    Taoyuan, 333

Other trials in Taiwan

Croatia4 sites

  • Klinicki bolnicki centar Rijeka ( Site 4005)

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinika za psihijatriju Vrapce ( Site 4000)

    Zagreb, City of Zagreb, 10090

  • Klinika za psihijatriju Vrapce ( Site 4001)

    Zagreb, City of Zagreb, 10090

  • Klinika za psihijatriju Sveti Ivan ( Site 4003)

    Zagreb, Zagreb County, 10090

Other trials in Croatia

South Korea3 sites

  • Inje University Busan Paik Hospital ( Site 0604)

    Busan, Pusan-Kwangyokshi, 47392

  • Kyungpook National University Hospital ( Site 0601)

    Daegu, Taegu-Kwangyokshi, 41944

  • Seoul National University Hospital ( Site 0600)

    Seoul, 03080

Other trials in South Korea

Latvia2 sites

  • Daugavpils Psihoneirologiska Slimnica ( Site 8005)

    Daugavpils, 5417

  • Piejuras Slimnica Psihiatriska Klinika ( Site 8001)

    Liepāja, 3401

Other trials in Latvia

About this study

Official title: A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia

The purpose of this study was to evaluate the efficacy and safety of elpipodect at a range of doses (8 mg, 16 mg, and 24 mg once daily [QD]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses were the following: (1) that elpipodect 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, and (2) that elpipodect 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score.

With Amendment 4, enrollment was changed to approximately 500 participants with removal of the elpipodect 8 mg treatment arm. Participants enrolled before Amendment 4 who were assigned to elpipodect 8 mg QD remained on that dose regimen per protocol.

Conditions
Schizophrenia
Being tested
Elpipodect, Risperidone, Placebo to MK-8189, Placebo to risperidone
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElpipodectDrug

    Also called MK-8189

    MK-8189 administered QD at a dose of 8 mg, 16 mg, or 24 mg via oral tablet.

  • RisperidoneDrug

    Risperidone administered QD at a dose of 6 mg via oral capsule.

  • Placebo to MK-8189Drug

    MK-8189-matching placebo administered QD via oral tablet.

  • Placebo to risperidoneDrug

    Risperidone-matching placebo administered QD via oral capsule.

Study groups in NCT04624243
Study groupRoleWhat they receive
Elpipodect 8 mgExperimentalParticipants received elpipodect 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up
Receives: Drug: Elpipodect; Drug: Placebo to risperidone
Elpipodect 16 mgExperimentalParticipants received elpipodect 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Receives: Drug: Elpipodect; Drug: Placebo to risperidone
Elpipodect 24 mgExperimentalParticipants received elpipodect 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Receives: Drug: Elpipodect; Drug: Placebo to risperidone
Risperidone 6 mgActive comparatorParticipants 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.
Receives: Drug: Risperidone; Drug: Placebo to MK-8189
Placebo and Elpipodect 24 mgExperimentalParticipants received placebo QD from Weeks 1 to 6 and elpipodect 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.
Receives: Drug: Elpipodect; Drug: Placebo to MK-8189; Drug: Placebo to risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6

    The PANSS assesses the severity of schizophrenia symptoms through a 30-item clinician-rated inventory organized into a positive subscale (7 items), a negative subscale (7 items) and a general psychopathology subscale (16 items). For each item, symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranges from 30 (lowest total score) to 210 (highest total score). Higher and lower change scores reflect symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.

    Measured: Baseline and Week 6

  2. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, events were assessed for the first 6 weeks of treatment.

    Measured: Up to Week 6

  3. Number of Participants Who Discontinued From Study Intervention Due to AE

    An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, events were assessed for the first 6 weeks of treatment.

    Measured: Up to Week 6

Secondary outcomes (6)

  1. Change From Baseline in PANSS Positive Subscale (PSS) Score at Week 6

    The PANSS Positive Subscale (PSS) assesses the severity of schizophrenia symptoms. The PANSS PSS score was calculated as the sum of the rating assigned to each of the 7 PSS items and ranges from 7 (lowest total score) to 49 (highest total score). Higher and lower change scores reflect symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.

    Measured: Baseline and Week 6

  2. Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6

    The CGI-S is a single item 7-point clinician rated scale for assessing the global severity of the participant's illness. CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill); higher and lower change from baseline scores indicate symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.

    Measured: Baseline and Week 6

  3. Change From Baseline in Body Weight at Week 12

    The change from baseline in body weigh was determined at Week 12. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.

    Measured: Baseline and Week 12

  4. Change From Baseline in Body Weight at Week 6

    The change from baseline in body weigh was determined at Week 6. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.

    Measured: Baseline and Week 6

  5. Change From Baseline in Body Weight at Week 12: Model-based Analysis

    The change from baseline in body weigh was determined at Week 12. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.

    Measured: Baseline and Week 12

  6. Change From Baseline in Body Weight at Week 6: Model-based Analysis

    The change from baseline in body weigh was determined at Week 6. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.

    Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2020
  2. Study start15 Dec 2020
  3. Primary completion21 Jun 2024
  4. Study completion21 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624243
Sponsor's protocol ID
8189-008
Other IDs
MK-8189-008, jRCT2071200096, 2020-000094-24
Status last verified
Apr 2026
First submitted
5 Nov 2020
Last updated
29 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elpipodect and Risperidone in people with Schizophrenia, run by Merck Sharp & Dohme LLC at 121 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, Japan, Russia, Ukraine, Serbia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (time frame: Baseline and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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