PET Trial to Assess the Receptor Occupancy of Brexpiprazole in Adult Subjects With Schizophrenia

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

The purpose of this study is to determine how low and high does of brexpiprazole binds to certain receptors in the brain. This will be determined by PET scans taken pre-dose and post-dose.

Key facts

Study ID

NCT01854944

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

12

Starts

2013-09-01

Expected to finish

2014-08-01

Last updated by the study team

2016-02-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of Schizophrenia.
• Ability to provide written informed consent.
• Ability to understand the protocol and meet the protocol requirements.
• Must be in good physical health determined by ECG and laboratory values, medical history and physical examinations.
• Has stable disease, defined as meeting all of the following criteria: A CGI-S score <= 4 (moderately ill); A PANSS total score <= 60; A score of <= 4 (moderate) on any of the following PANSS items: (P7 (hostility); G8 (uncooperativeness)).
• Body mass index of 19 to 35 kg/m2

You may not qualify if…

• Sexually active males and females of childbearing potential who are not practicing double-barrier birth control, or who will not remain abstinent, during the trial and for 30 days following the last dose of trial medication. If employing birth control, 2 of the following precautions must be used: vasectomy, partner who uses hormonal contraception, tubal ligation, vaginal diaphragm, nonhormonal intrauterine device, condom, or sponge with spermicide.
• Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of trial medication for all female subjects.
• Subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator.
• Subjects who have received continuous medication therapy to treat schizophrenia for less than 6 months prior to the drug-free interval.
• Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history, who have a history of failure to clozapine, or who are responsive only to clozapine treatment.
• Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia including MDD, bipolar disorder, delirium, dementia, amnestic, or other cognitive disorders or subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
• Subjects who, in the opinion of the investigator, cannot be rated reliably on the battery of movement rating scales required by the protocol.
• Subjects with a significant risk of violent behavior, a significant risk of committing suicide based on history or investigator's judgment, or who have attempted suicide within 2 years of cohort assignment.
• Subjects with clinically significant tardive dyskinesia at enrollment.
• Subjects who experience clinical deterioration during the drug-free interval, such that they require prohibited rescue therapy, will not meet the trial criteria and will be replaced.
• Subjects who experienced an acute exacerbation requiring hospitalization within 3 months prior to the Screening Visit or between the Screening and Baseline Visits.
• Subjects who experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks prior to baseline.
• Subjects who have a history of myocardial infarction, hypertension, or diabetes or who have evidence of other medical conditions that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial, including, but not limited to, hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease. The medical monitor must be contacted to discuss any such condition prior to cohort assignment.
• Subjects who have any of the following neurologic diagnoses, whether under treatment or not, whether stable or not: migraine, epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, residual of stroke, transient cerebral ischemic attacks, cerebral palsy, or any condition that requires intermittent or maintenance treatment or which is manifested by any abnormality on neurologic examination. A subject with tardive dyskinesia or other nonclinically significant symptoms of EPS due solely to the current or prior use of antipsychotic medications is not excluded by this criterion. Single-nerve peripheral palsies are also not excluded by this criterion: eg, Bell's palsy or radial-nerve palsy or fixed residuals from traumatic injury.
• History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg and/or anti-HCV or HIV antibodies.
• Subjects with a history of thyroid pathology (unless the condition has been stabilized with medications for at least the past 3 months) and/or abnormal thyroid laboratory results.
• Subjects with a history of neuroleptic malignant syndrome.
• Subjects with a history of seizure disorder.
• Subjects who meet DSM-IV-TR criteria for substance dependence within 6 months prior to cohort assignment (excluding caffeine and nicotine), including alcohol and benzodiazepines, and/or a positive alcohol (breath or urine) test or a positive urine screen for drugs of abuse. (In the case where a subject had a positive screen for stimulants and/or marijuana and was therefore excluded, the medical monitor should be contacted to determine if rescreening is an option.)
• Subjects who had any major surgery, any blood transfusion, or donated blood or plasma within 30 days prior to enrollment.
• The following laboratory test, vital sign, and ECG results are exclusionary:
• Platelets <= 75,000/mm3
• Hemoglobin <= 9 g/dL
• Neutrophils, absolute <= 1000/mm3
• AST > 2 times upper limit of normal

Where it is running

• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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