Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental S… (NCT01250847) | Clinical Trial Compass
UnknownPhase 4
Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS)
South Korea83 participantsStarted 2010-11
Plain-language 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 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)
Who can participate
Age range
20 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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) .
Exclusion criteria
. Pregnancy or lactation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. 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