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

Completed

• Conditions: Normal Volunteers
• Interventions: Drug: risperidone; Drug: aripiprazole; Drug: haloperidol; Drug: amisulpride; Drug: lactose

• Registration Number: NCT01185418
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-03
• Study Start: 2009-03
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-19
• Last Update Submitted: 2010-08-19
• Study First Posted: 2010-08-20
• Last Update Posted: 2010-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
risperidone	risperidone	-
aripiprazole	aripiprazole	-
haloperidol	haloperidol	-
amisulpride	amisulpride	-
lactose	lactose	-

Primary Outcome Measures

Name	Time	Method
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 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	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 Outcome Measures

Name	Time	Method
Symptoms assessment by objective rating scale	24hour	BARS, SAS

Trial Locations

Locations (1)

Chonbuk national university hospital; 🇰🇷 Jeonju, Korea, Republic of