An Active-Controlled Early Phase Study of MK-8189 in Adults With Schizophrenia (MK-8189-005)



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:12/27/2018
Start Date:March 8, 2017
End Date:January 9, 2018

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A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of MK-8189 Using Risperidone as an Active Control in Subjects Experiencing an Acute Episode of Schizophrenia

This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial
of MK-8189 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 MK-8189 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.


Inclusion Criteria:

- 18 to 50 years of age at Screening

- Male

- Female not of reproductive potential (e.g., postmenopausal or has had a hysterectomy),
or agrees to practice abstinence or use acceptable contraception

- Meets the diagnostic criteria for schizophrenia according to the DSM-5 criteria, or
has a past diagnosis of schizophrenia with the onset of the first episode being >=1
year prior to study entry, and has illness duration of <=20 years

- Is confirmed to be experiencing an acute episode of schizophrenia

- Minimum PANSS score >= 80 at Screening

- Has a score of >=4 in 3 or more of the following items (delusions, conceptual
disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution) in
the positive subscale of the PANSS at Screening

- Has a CGI-S score >= 4 at Screening

- Is able to taper off psychotropic medications without significant destabilization or
increased suicidality

- Has responded positively to an antipsychotic medication other than clozapine in a
prior psychotic episode

- Has an identified responsible external contact person who has regular contact (no less
than once per week) with the participant

Exclusion Criteria:

- Is currently under involuntary commitment because he/she is considered a danger to
himself/herself or others

- Is unwilling to remain hospitalized for the duration of trial treatment

- Is currently participating in or has participated in an interventional clinical
research study <=6 months prior to Screening, or has participated in more than one
interventional clinical trial research study within 12 months prior to Screening

- Is unwilling to allow audio/video taping of the Mini International Neuropsychiatric
Interview for Schizophrenia and Psychotic Disorders (MINI) and/or PANSS interview at
Screening and Baseline

- Is currently being treated with and benefiting from medications with a moderate or
strong inhibiting or inducing effect on Cytochrome P450 (CYP) 3A and/or CYP2C9 and/or
sensitive substrates of CYP2B6

- Has a history of malignancy <= 5 years except for adequately treated basal cell or
squamous cell skin cancer or in situ cervical cancer

- Has a body mass index <18.5 or >40 kg/m˄2

- Has a history of treatment-resistant schizophrenia

- Has a prolactin laboratory value of >= 5 times the upper limit of normal at Screening

- Has a known history or clinical evidence of clinically significant hepatic,
cardiovascular, or renal disease, or of untreated narrow-angle glaucoma- Has ever been
diagnosed with epilepsy or had any seizure disorder beyond one childhood febrile
seizure

- Has known serological evidence of human immunodeficiency virus (HIV) antibody

- Has a history of neuroleptic malignant syndrome

- Has a current diagnosis other than schizophrenia, or a comorbid diagnosis primarily
responsible for current symptoms and functional impairment

- Has a known history of borderline personality disorder, antisocial personality
disorder, or bipolar disorder

- Has a known history of traumatic brain injury, or Alzheimer's disease or another form
of dementia

- Currently meets DSM-5 criteria for substance abuse or alcohol use disorder

- Is at imminent risk of self-harm or harm to others
We found this trial at
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Richardson, Texas 75080
Phone: 214-417-5766
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1100 Lake Hearn Dr
Atlanta, Georgia 30342
404-255-6005
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Phone: 404-881-5800
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Bellflower, California 90706
Phone: 562-748-4999
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Cerritos, California 90703
Phone: 646-774-8436
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Dayton, Ohio 45417
Phone: 937-424-1050
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DeSoto, Texas 75115
Phone: 972-283-6286
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Flowood, Mississippi 39232
Phone: 601-420-5810
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Gaithersburg, Maryland 20877
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Garden Grove, California 92845
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Glendale, California 91204
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Hoffman Estates, Illinois 60169
Phone: 847-230-3958
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Hollywood, Florida 33021
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Lake Charles, Louisiana 70601
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Las Vegas, Nevada 89102
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Lemon Grove, California 91945
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Little Rock, Arkansas 72211
Phone: 501-221-8681
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New York, New York 10019
Phone: 718-969-3005
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1400 East Oakland Park Boulevard
Oakland Park, Florida 33334
Phone: 954-990-7649
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Orange, California 92868
Phone: 714-289-1100
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5151 Adanson Street
Orlando, Florida 32810
Phone: 866-669-0234
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Pico Rivera, California 90660
Phone: 562-928-8601
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609 West Dyke Road
Rogers, Arkansas 72758
Phone: 479-927-3000
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Saint Louis, Missouri 63141
Phone: 314-771-6387
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5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
Phone: 314-849-1853
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San Diego, California 92123
Phone: 858-278-3647
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Sherman Oaks, California 91403
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Torrance, California 90502
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