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Clinical Trials/NCT01185418
NCT01185418CompletedNot Applicable

Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer: a Double-blind, Randomized Trial of a Single Dose of Placebo, Haloperidol, Amisulpride, Risperidone and Aripiprazole

Chonbuk National University Hospital1 site in 1 country80 target enrollmentStarted: March 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Symptoms assessment by objective and subjective rating scales & CNT

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 38 Years (Adult)
Sex
All
Accepts 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

  • anyone who participated in other clinical trials within 30 days from the start of this clinical trial or is currently participating in one,
  • anyone who has progressive disease or in unstable medical condition unfit for the trial,
  • 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,
  • anyone who is suicidal or highly probable of suicides, or
  • anyone who has test results considered clinically meaningful

Arms & Interventions

aripiprazole

Intervention: aripiprazole (Drug)

risperidone

Intervention: risperidone (Drug)

haloperidol

Intervention: haloperidol (Drug)

amisulpride

Intervention: amisulpride (Drug)

lactose

Intervention: lactose (Drug)

Outcomes

Primary Outcomes

Symptoms assessment by objective and subjective rating scales & CNT

Time Frame: 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 scale

Time Frame: 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

Time Frame: 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 Outcomes

  • Symptoms assessment by objective rating scale(24hour)

Investigators

Sponsor Class
Other

Study Sites (1)

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