Normal VolunteersNCT01185418
Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer
An observational study of Normal Volunteers, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
The aim of the study is to investigate the negative symptoms and cognitive function after administration of antipsychotics in healthy volunteer. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Volunteers
- What is being tested?
- risperidone, aripiprazole and haloperidol
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the Structured Clinical Interview for DSM-IV, research version.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The aim of the study is to investigate the negative symptoms and cognitive function after administration of antipsychotics in healthy volunteer.
- Conditions
- Normal Volunteers
- Being tested
- risperidone, aripiprazole, haloperidol, amisulpride, lactose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
aripiprazoleDrug
haloperidolDrug
amisulprideDrug
lactoseDrug
| Study group | Role | What they receive |
|---|---|---|
| risperidone | Not described Receives: Drug: risperidone | |
| aripiprazole | Not described Receives: Drug: aripiprazole | |
| haloperidol | Not described Receives: Drug: haloperidol | |
| amisulpride | Not described Receives: Drug: amisulpride | |
| lactose | Not described Receives: Drug: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 24hour
Secondary outcomes (2)
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
Measured: 4hour
Symptoms assessment by objective rating scale
BARS, SAS
Measured: 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185418
- Sponsor's protocol ID
- CBIRB0226-22
- Status last verified
- Mar 2009
- First submitted
- 18 Aug 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01185418
- Acronym / sponsor ID
- CBIRB0226-22
- Conditions
- Normal Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the negative symptoms and cognitive function after administration of antipsychotics in healthy volunteer.
Study design
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| risperidone | – | Drug: risperidone |
| aripiprazole | – | Drug: aripiprazole |
| haloperidol | – | Drug: haloperidol |
| amisulpride | – | Drug: amisulpride |
| lactose | – | Drug: lactose |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the Structured Clinical Interview for DSM-IV, research version.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risperidone | Drug | risperidone |
| aripiprazole | Drug | aripiprazole |
| haloperidol | Drug | haloperidol |
| amisulpride | Drug | amisulpride |
| lactose | Drug | lactose |
Primary outcome
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)
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
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
2 secondary outcomes
Symptoms assessment by objective rating scale
Time frame: 4hour
Symptoms assessment by objective rating scale
Time frame: 24hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Volunteers, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms assessment by objective and subjective rating scale (time frame: 2 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2010.