Study Seeking Patients with Schizophrenia

  • STATUS
    Recruiting
  • sponsor
    Merck
Updated on 25 March 2021

Summary

Study Seeking Patients with Schizophrenia

Description

A Phase II, 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

Details
Condition Schizophrenia and Schizoaffective Disorders, Mental Disability, Psychosis
Clinical Study IdentifierTX148303
SponsorMerck
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Ages 18-50, inclusive
BMI 18.5-40, inclusive
Diagnosed with Schizophrenia with the onset of the first episode at least one year but no more than 20 years prior to study entry
Currently experiencing an acute episode of schizophrenia with the onset less than or equal to 4 weeks prior to screening
Have previously responded to an antipsychotic medication other than Clozapine in a prior psychotic episode

Exclusion Criteria

Has participated in a research study in the past 6 months or more than one in the past year
Unwilling to allow audio/video recording of assessments
History of treatment resistance
Hepatitis that has been active in the past 6 months; HIV
Cardiovascular or Cerebrovascular disease
History of untreated narrow angle glaucoma
Has ever been diagnosed with epilepsy or had any seizure disorder beyond one childhood febrile seizure
History of neuroleptic malignant syndrome
Substance or Alcohol Use Disorder in the past 6 months
Positive UDS at screening; positive ETOH and/or THC may be allowed if they don’t meet criteria for abuse or dependence
Active suicidal ideation in the past 2 months or suicide attempt in the past 6 months
Committed an act of violence (assaultive behavior) within the past 2 years or is at risk for future assaultive behavior
History of significant multiple and/or severe allergies (food, drugs, latex) or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Allergy or sensitivity to Risperidone
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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