Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases; Schizophrenia; Psychotic Disorders
Intervention: EVP-6124 (0.3 mg/day); EVP-6124 (1.0 mg/day); Placebo; Antipsychotic therapy
Intervention description: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.; EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.; Matching placebo was administered as one capsule per day for 21 days.; Concomitant therapy with antipsychotic medication (aripiprazole [10 to 30 mg/day], olanzapine [10 to 20 mg/day], paliperidone [3 to 12 mg/day], or risperidone [2 to 16 mg/day]), taken at the same time each day as the EVP-6124 dose. Patients must have been taking concomitant therapy for at least 2 weeks at a stable dose to be eligible for the study.
Intervention MeSH terms: Antipsychotic Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizoaffective; CNS

Summary:

      This study in patients with schizophrenia is designed to provide preliminary evidence of the
      safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2
      doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 to 55 years (both inclusive).

          -  Females must be surgically sterile, post-menopausal, or using reliable contraception
             and have negative pregnancy tests at screening and at Day -1.

          -  A clinical diagnosis of schizophrenia or schizoaffective disorder and prescribed a
             stable dose of aripiprazole (10 to 30 mg/day), olanzapine (10 to 20 mg/day),
             paliperidone (3 to 12 mg/day), or risperidone (2 to 16 mg/day) for a minimum of 2
             weeks before initial screening.

          -  In good general health and expected to complete the clinical trial as designed.

          -  Body Mass Index (BMI) of 18 kg/m^2 to 38 kg/m^2 (both inclusive) at screening.

          -  Adequate hearing, vision, and language skills to perform the cognitive testing and
             other procedures specified in the protocol.

          -  Voluntarily provided informed consent and signed an informed consent form (ICF)
             indicating that the purpose of the study was explained, and was willing and able to
             adhere to the study regimen and study procedures described in the ICF, including all
             confinement requirements.

          -  Negative urine drug screen at screening and inpatient observation baseline period (Day
             -6), except for a short-acting benzodiazepine if prescribed for insomnia.

          -  Fluent in English (speaking, writing, and reading).

        Exclusion Criteria:

          -  Female subject who was pregnant or breast-feeding.

          -  Any active clinically significant medical condition within 1 month (30 days) prior to
             screening.

          -  A history of substance (drug) dependence or substance or alcohol abuse within the 12
             months before randomization as defined in the Diagnostic and Statistical Manual of
             Mental Disorders, 4th Edition (DSM-IV).

          -  A score of >5 on any item on the PANSS (Positive and Negative Syndrome Scale) Positive
             subscale at baseline during the inpatient observation period (Day -1).

          -  Any laboratory test abnormalities at screening indicating hepatic or renal
             dysfunction, or any other laboratory test abnormalities deemed by the investigator to
             be clinically significant.

          -  Any hematologic malignancy or solid tumor diagnosed within 3 years prior to study
             entry with the exception of localized skin cancer or carcinoma in situ of the cervix.

          -  Known to have had or was a carrier of HBsAg, HCV antibody, or had a positive result to
             the HIV-1 and/or HIV-2 antibodies.

          -  Uncooperative with or could not complete the study procedures.

          -  Received an investigational drug within 30 days before screening.

          -  Donated blood within 30 days before randomization on Day 1.