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

NCT01185418 | Completed

• 1 other identifier: CBIRB0226-22
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Normal Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Symptoms assessment by objective rating scale

  4hour

• Symptoms assessment by objective rating scale

  24hour

Study Arms (5)

risperidone

Drug: risperidone

aripiprazole

Drug: aripiprazole

haloperidol

Drug: haloperidol

amisulpride

Drug: amisulpride

lactose

Drug: lactose

Interventions

risperidone DRUG

risperidone

aripiprazole DRUG

aripiprazole

haloperidol DRUG

haloperidol

amisulpride DRUG

amisulpride

lactose DRUG

lactose

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Recruited volunteers among normal adults aged from 18 to 38 who responded advertisements for research subjects. Then selected subjects from the applicants using various screening tests - physical and neurological examination including confirming vital signs after examining physical health and sleep habits of volunteers

You may qualify if:

• Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the Structured Clinical Interview for DSM-IV, research version.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Chonbuk national university hospital

Jeonju, South Korea

Location

MeSH Terms

Interventions

Risperidone; Aripiprazole; Haloperidol; Amisulpride; Lactose

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Butyrophenones; Ketones; Organic Chemicals; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 20, 2010
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 20, 2010

Record last verified: 2009-03

Locations

KR (1)