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Completed

NCT Number: NCT01185418

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

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

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Key information

Conditions

Normal Volunteers

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonbuk national university hospital

Jeonju, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone

Drug

Aripiprazole

Drug

Haloperidol

Drug

Amisulpride

Drug

lactose

Drug

Primary outcomes

  1. 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)

  2. 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

  3. 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

  1. Symptoms assessment by objective rating scale

    Time frame: 4hour

    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

  2. Symptoms assessment by objective rating scale

    Time frame: 24hour

    BARS, SAS

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2010
Registry last updated
Aug 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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