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

• Sponsor: Chonbuk National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01185418
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 20

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Normal Volunteers	Drug: risperidone; Drug: aripiprazole; Drug: haloperidol; Drug: amisulpride; Drug: lactose

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• 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
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
risperidone	Drug: risperidone
aripiprazole	Drug: aripiprazole
haloperidol	Drug: haloperidol
amisulpride	Drug: amisulpride
lactose	Drug: lactose

Outcome Measures

Primary Outcome Measures

1. Symptoms assessment by objective and subjective rating scale [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 [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 [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 Outcome Measures

1. Symptoms assessment by objective rating scale [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 [24hour]

   BARS, SAS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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,
• 1. anyone who has progressive disease or in unstable medical condition unfit for the trial,
• 1. 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,
• 1. anyone who is suicidal or highly probable of suicides, or
• 1. anyone who has test results considered clinically meaningful

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonbuk national university hospital	Jeonju		Korea, Republic of

Sponsors and Collaborators

• Chonbuk National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01185418
• Other Study ID Numbers: CBIRB0226-22
• First Posted: Aug 20, 2010
• Last Update Posted: Aug 20, 2010
• Last Verified: Mar 1, 2009

• Additional relevant MeSH terms: Haloperidol; Risperidone; Aripiprazole; Haloperidol decanoate; Amisulpride

Study Results

No Results Posted as of Aug 20, 2010