Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer

Chonbuk National University Hospital80 enrolled

Overview

The aim of the study is to investigate the negative symptoms and cognitive function after administration of antipsychotics in healthy volunteer.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Normal Volunteers

Interventions

risperidoneDRUG

aripiprazoleDRUG

haloperidolDRUG

amisulprideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 38 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chonbuk national university hospital

Jeonju, South Korea

Outcomes

Primary Outcomes

Symptoms assessment by objective and subjective rating scale

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)

Time frame: 2 hour

Symptoms assessment by objective and subjective rating scales & CNT

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

Time frame: 4hour

Symptoms assessment by objective and subjective rating scales

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

Time frame: 24hour

Secondary Outcomes

Symptoms assessment by objective rating scale

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

Time frame: 4hour

Symptoms assessment by objective rating scale

Data from ClinicalTrials.gov

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