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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8189-005 | Other Identifier | Merck Protocol Number |
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This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of elpipodect compared with placebo, using Risperidone as an active control. The participants will be adult subjects experiencing an acute episode of schizophrenia, according to the criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each participant. The study will consist of a Screening/tapering period (up to one week long), a 4-week treatment period, and a 14-day follow-up period. The primary objective will be to assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during treatment and post-treatment follow-up. The secondary objective will be to assess the severity of schizophrenia at 4 weeks. The primary hypothesis is that elpipodect is superior to placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elpipodect | Experimental | Participants receive elpipodect (4 mg controlled release [CR] oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) once daily (QD) for 4 weeks. Over the initial 7 treatment days, elpipodect is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is also titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, elpipodect is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks. |
|
| Risperidone | Active Comparator | Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching elpipodect (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching elpipodect is also titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching elpipodect (3 tablets), QD for 3 weeks. |
|
| Placebo | Placebo Comparator | Participants receive both placebo matching elpipodect (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both elpipodect and risperidone are respectively titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both elpipodect and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elpipodect | Drug | Oral CR tablets (4 mg) administered QD at the following dose strengths: 4 mg (1 tablet); 8 mg (2 tablets); 12 mg (3 tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean (LSM) Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | The LSM change from baseline at week 4 was assessed for PANSS total score. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and sum to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, reduced symptom severity over time is reflected by decreases in score. | Baseline and Week 4 |
| Percentage of Participants Experiencing an Adverse Event (AE) | The percentage of participants experiencing an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Up to 6 weeks |
| Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event | The percentage of participants discontinuing study treatment due to an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean (LSM) Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4 | The LSM change from baseline at week 4 was assessed for CGI-S score. The CGI-S is a 7-point clinician-rated scale for assessing the global severity of the participant's illness. Possible CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). Further, a decrease in CGI-S score indicates reduced severity of the participant's illness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group, LLC ( Site 0001) | Little Rock | Arkansas | 72211 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38851166 | Result | Mukai Y, Lupinacci R, Marder S, Snow-Adami L, Voss T, Smith SM, Egan MF. Effects of PDE10A inhibitor MK-8189 in people with an acute episode of schizophrenia: A randomized proof-of-concept clinical trial. Schizophr Res. 2024 Aug;270:37-43. doi: 10.1016/j.schres.2024.05.019. Epub 2024 Jun 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-8189 | Participants receive MK-8189 (4 mg controlled release [CR] oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) once daily (QD) for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is mock titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Mar 29, 2017 |
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Participants will be randomly assigned to one of three groups in parallel for the duration of the study.
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A double-blind/masking technique will be used. MK-8189 and risperidone will be packaged identically relative to their respective matching placebo so that blinding/masking is maintained.
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| Risperidone | Drug | Oral capsules (2 mg) administered QD at the following dose strengths: 2 mg (1 capsule); 4 mg (2 capsules); 6 mg (3 capsules) |
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| Placebo matching MK-8189 | Drug | Oral placebo tablet(s) matching the MK-8189 tablet, administered QD. |
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| Placebo matching risperidone | Drug | Oral placebo capsule(s) matching the risperidone capsule, administered QD. |
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| Baseline and Week 4 |
| Woodland Research Northwest, LLC ( Site 0014) |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| CITRIALS ( Site 0013) | Bellflower | California | 90706 | United States |
| Comprehensive Clinical Development ( Site 0049) | Cerritos | California | 90703 | United States |
| Collaborative Neuroscience Network, LLC ( Site 0057) | Garden Grove | California | 92845 | United States |
| Behavioral Research Specialists, LLC ( Site 0006) | Glendale | California | 91206 | United States |
| Synergy East ( Site 0003) | Lemon Grove | California | 91945 | United States |
| NRC Research Institute ( Site 0043) | Orange | California | 92868 | United States |
| CNRI - Los Angeles, LLC ( Site 0026) | Pico Rivera | California | 90660 | United States |
| Artemis Institute for Clinical Research ( Site 0027) | San Diego | California | 92103 | United States |
| Schuster Medical Research Institute ( Site 0032) | Sherman Oaks | California | 91403 | United States |
| Collaborative Neuroscience Network, LLC ( Site 0046) | Torrance | California | 90502 | United States |
| Larkin Community Hospital Behavioral Health Services ( Site 0020) | Hollywood | Florida | 33021 | United States |
| Clinical Research Centers of America, LLC ( Site 0038) | Oakland Park | Florida | 33334 | United States |
| Aspire Health Partners ( Site 0016) | Orlando | Florida | 32810 | United States |
| Radiant Research - Atlanta ( Site 0008) | Atlanta | Georgia | 30328 | United States |
| Atlanta Center For Medical Research ( Site 0056) | Atlanta | Georgia | 30331 | United States |
| Alexian Center for Psychiatric Research ( Site 0015) | Hoffman Estates | Illinois | 60169 | United States |
| Lake Charles Clinical Trials, LLC ( Site 0040) | Lake Charles | Louisiana | 70629 | United States |
| CBH Health, LLC ( Site 0022) | Gaithersburg | Maryland | 20877 | United States |
| Precise Research Centers ( Site 0018) | Flowood | Mississippi | 39232 | United States |
| Psych Care Consultants Research ( Site 0025) | St Louis | Missouri | 63128 | United States |
| St. Louis Clinical Trials, LLC ( Site 0012) | St Louis | Missouri | 63141 | United States |
| Altea Research Institute ( Site 0017) | Las Vegas | Nevada | 89102 | United States |
| Radiant Research -CliniLabs ( Site 0037) | New York | New York | 10019 | United States |
| Midwest Clinical Research Unit ( Site 0041) | Dayton | Ohio | 45417 | United States |
| InSite Clinical Research ( Site 0033) | DeSoto | Texas | 75115 | United States |
| Pillar Clinical Research, LLC ( Site 0004) | Richardson | Texas | 75080 | United States |
| FG001 | Risperidone | Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is mock titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks. |
| FG002 | Placebo | Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-8189 | Participants receive MK-8189 (4 mg CR oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) QD for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is mock titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks. |
| BG001 | Risperidone | Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is mock titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks. |
| BG002 | Placebo | Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and sum to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. | Includes all randomized participants who: 1) received ≥1 dose of study treatment; 2) had a baseline PANSS assessment; and 3) had ≥1 post-randomization observation for PANSS score subsequent to ≥1 dose of study treatment. | Mean | Standard Deviation | Score on a Scale |
| ||||||||
| Clinical Global Impression Severity of Illness (CGI-S) Score | The CGI-S is a 7-point clinician-rated scale for assessing the global severity of the participant's illness. Possible CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). | Includes all randomized participants who: 1) received ≥1 dose of study treatment; 2) had a baseline CGI-S assessment; and 3) had ≥1 post-randomization observation for CGI-S score subsequent to ≥1 dose of study treatment. | Mean | Standard Deviation | Score on a Scale |
| ||||||||
| Duration of Illness | Count of Participants | Participants |
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| 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 | Least Squares Mean (LSM) Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | The LSM change from baseline at week 4 was assessed for PANSS total score. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and sum to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, reduced symptom severity over time is reflected by decreases in score. | Includes all randomized participants who: 1) received ≥1 dose of study treatment; 2) had a baseline PANSS assessment; and 3) had ≥1 post-randomization observation for PANSS score subsequent to ≥1 dose of study treatment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and Week 4 |
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| Primary | Percentage of Participants Experiencing an Adverse Event (AE) | The percentage of participants experiencing an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Includes all randomized and treated participants. | Posted | Number | Percentage of Participants | Up to 6 weeks |
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| Primary | Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event | The percentage of participants discontinuing study treatment due to an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Includes all randomized and treated participants. | Posted | Number | Percentage of Participants | Up to 4 weeks |
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| Secondary | Least Squares Mean (LSM) Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4 | The LSM change from baseline at week 4 was assessed for CGI-S score. The CGI-S is a 7-point clinician-rated scale for assessing the global severity of the participant's illness. Possible CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). Further, a decrease in CGI-S score indicates reduced severity of the participant's illness. | Includes all randomized participants who: 1) received ≥1 dose of study treatment; 2) had a baseline CGI-S assessment; and 3) had ≥1 post-randomization observation for CGI-S score subsequent to ≥1 dose of study treatment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and Week 4 |
|
Up to 6 weeks
The analysis population includes all randomized and treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-8189 | Participants receive MK-8189 (4 mg CR oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) QD for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is mock titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks. | 0 | 90 | 0 | 90 | 53 | 90 |
| EG001 | Risperidone | Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is mock titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks. | 0 | 45 | 3 | 45 | 27 | 45 |
| EG002 | Placebo | Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks. | 0 | 89 | 3 | 89 | 31 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis externa | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Dec 6, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000729358 | MK-8189 |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
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|
|
| Longitudinal ANCOVA |
Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment. |
| 0.074 |
| Difference in LSM |
| -4.7 |
| 2-Sided |
| 95 |
| -9.8 |
| 0.5 |
Difference in LSM = MK-8189 - Placebo |
| Superiority |
| Longitudinal ANCOVA | Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment. | 0.033 | Difference in LSM | -7.3 | 2-Sided | 95 | -14.0 | -0.6 | Difference in LSM = Risperidone - Placebo | Superiority |
| OG002 | Placebo | Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks. |
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Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is mock titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks.
| OG002 | Placebo | Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks. |
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| OG002 | Placebo | Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks. |
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