A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

• Status: Recruiting
• Trial end date: 2021-09-03
• Target enrollment: 0
• Participant gender: All

Summary

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 50 locations worldwide. The study will last up to 9 weeks total time.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion

Criteria

Inclusion Criteria:

1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.

2. Subject or subjects parent/legal guardian [adolescents] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..

3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening

4. Subject must have a CGI-S score ≥ 4

5. Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content

6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).

7. Subject has marked deterioration of functioning in one or more areas.

8. Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.

Exclusion Criteria:

1. Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months or lifetime history of significant substance abuse that in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.

2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.

3. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:

4. Female subject who is pregnant or lactating

5. Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.