F-18 Altanserin PET Study of Patients Receiving Clozapine (APC)

Seoul National University

Status: Unknown

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: clozapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01398189

SNUBH 04-2011-050

Details and patient eligibility

About

To examine the feasibility of molecular imaging markers in clinical psychopharmacology

Full description

Clinical evaluation of patients with psychiatric disorders is mainly dependent on patients' reports and clinicians' observations. In order to develop objective and quantifiable measures of psychopathology, molecular imaging techniques will be used in patients receiving clozapine.

Enrollment: 12 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overtly healthy males as determined by medical history and physical examination
• Age from 19 to 45 years
• Weight ≥ 45 kg and within ± 20% of IBW
• Clinical laboratory test results within normal reference range for the National Cancer Center, Hospital or results with minor deviations which are judged to be not clinically significant by the investigator
• Normal blood pressure and heart rate (supine and standing) as determined by the investigator
• Are reliable and willing to make themselves available for the duration of the study, and who will abide by the study restrictions
• Have given written informed consent

Exclusion criteria

• Evidence of significant active hematologic disease
• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
• An episode of febrile disease or infectious disease within the past 2 weeks
• Evidence of significant active neuropsychiatric disease
• Regular use of drugs or abuse
• History of drug hypersensitivity or clinically significant allergic reactions of any origin
• Participation in a study involving administration of an investigational compound within the past 30 days
• Use of any current medication
• Smoking history for recent 3 months

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

clozapine

Experimental group

Description:

patients with refractory schizophrenia or schizoaffective disorder

Treatment:

Drug: clozapine