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
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)