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

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

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

Study Overview

• Status: Completed
• Conditions: Normal Volunteers
• Intervention / Treatment: Drug: risperidone; Drug: aripiprazole; Drug: haloperidol; Drug: lactose; Drug: amisulpride

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
risperidone	Drug: risperidone
aripiprazole	Drug: aripiprazole
haloperidol	Drug: haloperidol
amisulpride	Drug: amisulpride
lactose	Drug: lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Symptoms assessment by objective rating scale	BARS, SAS	24hour

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (Estimate): August 20, 2010

Study Record Updates

• Last Update Posted (Estimate): August 20, 2010
• Last Update Submitted That Met QC Criteria: August 19, 2010
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Antidepressive Agents, Second-Generation; Anti-Dyskinesia Agents; Aripiprazole; Risperidone; Amisulpride; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: CBIRB0226-22