Abnormal Mental StatePhase 4ES-ARMSNCT01250847
Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS)
A Phase 4 study testing Quetiapine(Seroquel-XR) 50~800mg a day in people with Abnormal Mental State and Schizophrenia, run by Severance Hospital at 2 sites in South Korea.
Trial summary
The primary objective of this study is to assess the effects of 'Seroquel-XR' on the verbal learning ability in people with at-risk mental state (ARMS) over a 12 week period. The verbal learning ability will be indexed by delayed free recall score of CVLT(California Verbal learning Test), a standard neuropsychological… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormal Mental State, Schizophrenia
- What is being tested?
- Quetiapine(Seroquel-XR) 50~800mg a day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Nov 2010to Oct 2012
- Phase
- Phase 4
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent
- Male and female aged 20 to 35 years
- Able to understand and comply with the requirements of the study
- ARMS:
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
- ARMS was diagnosed by Structured Interview for Prodromal Syndrome (SIPS) .
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- Schizophrenia subjects:
- 4. Schizophrenia was diagnosed by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV). Patients with schizophrenia had to have been ill no more than 5 years. Subjects had to be clinically stable and on stable antipsychotic therapy for at least 4 weeks prior to baseline study.
- Normal control:
- 4. Healthy volunteers who had no history of psychiatric illness and had no first degree relative with psychotic symptoms were included for normal controls.
Who cannot join
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria. However, in the case of ARMS, psychotic disorder NOS, major depressive disorder, obsessive-compulsive disorder, and social phobia would be allowed.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
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- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrolment or randomisation of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) more than 8.5 percent.
- Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- Not under physician care for DM Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
- Physician responsible for patient's DM care has not approved patient's participation in the study Has not been on the same dose of oral hypoglycaemic drug(s) and(or) diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 weeks.
- Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10 percent above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- An absolute neutrophil count (ANC) of 1.5 folded 109 per liter
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Severance Mental Health Hospital
Gwangju, 464-100
SuYoung Lee, MD, +82 31 760 9405, LEESUYOUNG@yuhs.ac
Suk Kyoon An, MD, Ph D
- Recruiting
Severance Hospital
Seoul, 120-752
Suk Kyoon An, MD, Ph D, +82 17 349 8275, ansk@yuhs.ac
Suk Kyoon An, MD, Ph D
About this study
Official title: Phase IV Study of Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS)
The primary objective of this study is to assess the effects of 'Seroquel-XR' on the verbal learning ability in people with at-risk mental state (ARMS) over a 12 week period. The verbal learning ability will be indexed by delayed free recall score of CVLT(California Verbal learning Test), a standard neuropsychological verbal memory tests.
The secondary objective is to assess the effects of 'Seroquel-XR' on other cognitive function and psychiatric symptoms including psychotic, anhedonic symptoms, and impulsivity. The cognitive function abilities will be measured by standard neuropsychological tests as follows;
- Working memory: verbal \& spatial 2-back test
- Attention: Digit Span, 3-7 CPT(Continuous Performance Test)
- Executive function: WCST (Wisconsin Card Sorting Test)
- Visuo-spatial ability: Rey Complex Figure Task copy
- Visuomotor speed and planning: Trail making test A \& B
- Verbal fluency: Controlled Oral Word Association Test(COWAT) The scales of psychiatric symptoms which will be used are as follows;
- Psychotic symptoms: Scales of Prodromal scales (SOPS), Positive and negative syndrome scale (PANSS)
- Anhedonia: Social Anhedonia Scale (SAS), Physical Anhedonia Scale (PAS)
- Social cognition: Ambiguous Intention Hostility Questionnaire (AIHQ)
- Impulsivity: Barrett Impulsivity Scale (BIS)
- Conditions
- Abnormal Mental State, Schizophrenia
- Being tested
- Quetiapine(Seroquel-XR) 50~800mg a day
- Keywords
- ARMS, Ultra High Risk, Quetiapine, Verbal memory
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine(Seroquel-XR) 50~800mg a dayDrug
Also called Quetiapine(Seroquel-XR)
The only ARMS subjects will be given 50~800mg Seroquel-XR once daily for total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Seroquel-XR | Experimental | The subjects At-Risk Mental States will be treated with Quetiapine(Seroquel-XR) from baseline to end of trial. Receives: Drug: Quetiapine(Seroquel-XR) 50~800mg a day |
| Schizophrenia Comparator | Experimental | The subject with schizophrenia will be treated with standard treatment Receives: Drug: Quetiapine(Seroquel-XR) 50~800mg a day |
| Healthy Control Comparator | No intervention | The subjects will not be required to treat Receives: Drug: Quetiapine(Seroquel-XR) 50~800mg a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test
Change from baseline in Verbal learning ability measured by CVLT at 12 weeks
Measured: Baseline
California Verbal Learning Test
Change from baseline in Verbal learning ability measured by CVLT at 12 weeks
Measured: 12th week
Secondary outcomes (2)
verbal & spatial 2-back test, Digit Span, 3-7 CPT, WCST, Rey-CFT, TMT A & B, COWAT, SOPS, PANSS, SAS, PAS, AIHQ, BIS
Change from baseline in Working Memory etc. at 12 weeks
Measured: Baseline
verbal & spatial 2-back test, Digit Span, 3-7 CPT, WCST, Rey-CFT, TMT A & B, COWAT, SOPS, PANSS, SAS, PAS, AIHQ, BIS
Change from baseline in working memory etc. at 12 weeks
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Mental StateStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Suk Kyoon An, MD, Ph D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250847
- Sponsor's protocol ID
- ARMS-4001
- Acronym
- ES-ARMS
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS)
- ClinicalTrials.gov ID
- NCT01250847
- Acronym / sponsor ID
- ES-ARMS / ARMS-4001
- Conditions
- Abnormal Mental State, Schizophrenia
- Keywords
- ARMS, Ultra High Risk, Quetiapine, Verbal memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 1 Dec 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 primary objective of this study is to assess the effects of 'Seroquel-XR' on the verbal learning ability in people with at-risk mental state (ARMS) over a 12 week period. The verbal learning ability will be indexed by delayed free recall score of CVLT(California Verbal learning Test), a standard neuropsychological verbal memory tests.
The secondary objective is to assess the effects of 'Seroquel-XR' on other cognitive function and psychiatric symptoms including psychotic, anhedonic symptoms, and impulsivity. The cognitive function abilities will be measured by standard neuropsychological tests as follows;
- Working memory: verbal \& spatial 2-back test
- Attention: Digit Span, 3-7 CPT(Continuous Performance Test)
- Executive function: WCST (Wisconsin Card Sorting Test)
- Visuo-spatial ability: Rey Complex Figure Task copy
- Visuomotor speed and planning: Trail making test A \& B
- Verbal fluency: Controlled Oral Word Association Test(COWAT) The scales of psychiatric symptoms which will be used are as follows;
- Psychotic symptoms: Scales of Prodromal scales (SOPS), Positive and negative syndrome scale (PANSS)
- Anhedonia: Social Anhedonia Scale (SAS), Physical Anhedonia Scale (PAS)
- Social cognition: Ambiguous Intention Hostility Questionnaire (AIHQ)
- Impulsivity: Barrett Impulsivity Scale (BIS)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Seroquel-XR | Experimental | Drug: Quetiapine(Seroquel-XR) 50~800mg a dayThe subjects At-Risk Mental States will be treated with Quetiapine(Seroquel-XR) from baseline to end of trial. |
| Schizophrenia Comparator | Experimental | Drug: Quetiapine(Seroquel-XR) 50~800mg a dayThe subject with schizophrenia will be treated with standard treatment |
| Healthy Control Comparator | No intervention | Drug: Quetiapine(Seroquel-XR) 50~800mg a dayThe subjects will not be required to treat |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provision of written informed consent
- Male and female aged 20 to 35 years
- Able to understand and comply with the requirements of the study
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
- ARMS was diagnosed by Structured Interview for Prodromal Syndrome (SIPS) .
Key exclusion criteria (21 listed)
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria. However, in the case of ARMS, psychotic disorder NOS, major depressive disorder, obsessive-compulsive disorder, and social phobia would be allowed.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
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 |
|---|---|---|
| Quetiapine(Seroquel-XR) 50~800mg a dayAlso: Quetiapine(Seroquel-XR)The only ARMS subjects will be given 50~800mg Seroquel-XR once daily for total of 12 weeks. | Drug | Healthy Control Comparator, Schizophrenia Comparator, Seroquel-XR |
Primary outcome
California Verbal Learning Test
Time frame: Baseline
Change from baseline in Verbal learning ability measured by CVLT at 12 weeks
California Verbal Learning Test
Time frame: 12th week
Change from baseline in Verbal learning ability measured by CVLT at 12 weeks
2 secondary outcomes
verbal & spatial 2-back test, Digit Span, 3-7 CPT, WCST, Rey-CFT, TMT A & B, COWAT, SOPS, PANSS, SAS, PAS, AIHQ, BIS
Time frame: Baseline
verbal & spatial 2-back test, Digit Span, 3-7 CPT, WCST, Rey-CFT, TMT A & B, COWAT, SOPS, PANSS, SAS, PAS, AIHQ, BIS
Time frame: 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
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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.
Suk Kyoon An, MD, Ph D principal investigator
Severance Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine(Seroquel-XR) 50~800mg a day in people with Abnormal Mental State and Schizophrenia, run by Severance Hospital at 2 sites 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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suk Kyoon An, MD, Ph D. (+82 17 349 8275, ansk@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
California Verbal Learning Test (time frame: Baseline). The study lists 2 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 19 Aug 2011.