Normal Volunteers
Conditions
Brief summary
The aim of the study is to investigate the negative symptoms and cognitive function after administration of antipsychotics in healthy volunteer.
Interventions
DRUGrisperidone
DRUGaripiprazole
DRUGhaloperidol
DRUGamisulpride
DRUGlactose
Sponsors
Chonbuk National University Hospital
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the Structured Clinical Interview for DSM-IV, research version.
Exclusion criteria
* 1\) anyone who participated in other clinical trials within 30 days from the start of this clinical trial or is currently participating in one, * 2\) anyone who has progressive disease or in unstable medical condition unfit for the trial, * 3\) anyone who has been diagnosed in psychiatric terms in the past, depends on psychotropic substance, or has overdosed or depended on the substance or alcohol (except for coffee or tobacco) within 1 month from the trial start, * 4\) anyone who is suicidal or highly probable of suicides, or * 5\) anyone who has test results considered clinically meaningful
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms assessment by objective and subjective rating scale | 2 hour | VAS - mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed) |
| Symptoms assessment by objective and subjective rating scales & CNT | 4hour | SANS-alogia and blunted affect, SDSS-Subjective Deficit Syndrome Scale ,self-report questionnaire to measure lack of energy, blunted affect, and difficulty in or altered thinking, consisting of 19 questions, with the scales from 0 to 4 NIDSS-consists of 20 items with a five-point Likert scale (from 0, none to 4, severe) and has three subscales: avolition (five items), blunted affect (five items), and cognition (ten items), CNT-computerized neuropsychological test, VAS |
| Symptoms assessment by objective and subjective rating scales | 24hour | SANS, SDSS, NIDSS, VAS SANS-alogia and blunted affect, SDSS-Subjective Deficit Syndrome Scale ,self-report questionnaire to measure lack of energy, blunted affect, and difficulty in or altered thinking, consisting of 19 questions, with the scales from 0 to 4 NIDSS-consists of 20 items with a five-point Likert scale (from 0, none to 4, severe) and has three subscales: avolition (five items), blunted affect (five items), and cognition (ten items), VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms assessment by objective rating scale | 4hour | BARS-Barnes akathisia rating scale (BAS), consisting of 4 items, identifies drug-induced akathisia and measures severity, SAS-Simpson-angus scale (SAS), consisting of 10 items, measures neuroleptic induced parkinsonism |
Countries
South Korea
Outcome results
None listed