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

Normal Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185418
• Other study ID #: CBIRB0226-22
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: August 19, 2010
• Start date: March 2009
• Est. completion date: July 2009

Study information

• Verified date: March 2009
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Chonbuk National University Hospital Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 38 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Normal Volunteers

Intervention

Drug:
• risperidone

• aripiprazole

• haloperidol

• amisulpride

• lactose

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk national university hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 hour	Yes
Primary	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	4hour	Yes
Primary	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	24hour	Yes
Secondary	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	4hour	Yes
Secondary	Symptoms assessment by objective rating scale	BARS, SAS	24hour	Yes