Status:
UNKNOWN
Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS)
Lead Sponsor:
Severance Hospital
Conditions:
Abnormal Mental State
Schizophrenia
Eligibility:
All Genders
20-35 years
Phase:
PHASE4
Brief 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 abili...
Eligibility Criteria
Inclusion
- 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) .
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01250847
Start Date
November 1 2010
End Date
October 1 2012
Last Update
August 19 2011
Active Locations (2)
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1
Severance Mental Health Hospital
Gwangju, South Korea, 464-100
2
Severance Hospital
Seoul, South Korea, 120-752