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

This study has been completed.
Sponsor:
Information provided by:
Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01185418
First received: August 18, 2010
Last updated: August 19, 2010
Last verified: March 2009
  Purpose

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


Condition Intervention
Normal Volunteers
Drug: risperidone
Drug: aripiprazole
Drug: haloperidol
Drug: amisulpride
Drug: lactose

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Symptoms assessment by objective and subjective rating scale [ Time Frame: 2 hour ] [ Designated as safety issue: Yes ]
    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 & CNT [ Time Frame: 4hour ] [ Designated as safety issue: Yes ]
    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 scales [ Time Frame: 24hour ] [ Designated as safety issue: Yes ]
    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:
  • Symptoms assessment by objective rating scale [ Time Frame: 4hour ] [ Designated as safety issue: Yes ]
    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

  • Symptoms assessment by objective rating scale [ Time Frame: 24hour ] [ Designated as safety issue: Yes ]
    BARS, SAS


Enrollment: 80
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
risperidone Drug: risperidone
aripiprazole Drug: aripiprazole
haloperidol Drug: haloperidol
amisulpride Drug: amisulpride
lactose Drug: lactose

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185418

Locations
Korea, Republic of
Chonbuk national university hospital
Jeonju, Korea, Republic of
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Young Chul Chung/Professor of Psychiatry, Chonbuk National University Hospital, Jeonju, Korea
ClinicalTrials.gov Identifier: NCT01185418     History of Changes
Other Study ID Numbers: CBIRB0226-22
Study First Received: August 18, 2010
Last Updated: August 19, 2010
Health Authority: Republic of Korea: Chonbuk National University Hospital Institutional Review Board

Additional relevant MeSH terms:
Haloperidol
Haloperidol decanoate
Antipsychotic Agents
Risperidone
Sultopride
Aripiprazole
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on September 11, 2014