Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS) (ES-ARMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Severance Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Severance Hospital
ClinicalTrials.gov Identifier:
NCT01250847
First received: November 29, 2010
Last updated: August 18, 2011
Last verified: November 2010
  Purpose

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)

Condition Intervention Phase
Abnormal Mental State
Schizophrenia
Drug: Quetiapine(Seroquel-XR) 50~800mg a day
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS)

Resource links provided by NLM:


Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • California Verbal Learning Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Change from baseline in Verbal learning ability measured by CVLT at 12 weeks

  • California Verbal Learning Test [ Time Frame: 12th week ] [ Designated as safety issue: No ]
    Change from baseline in Verbal learning ability measured by CVLT at 12 weeks


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change from baseline in Working Memory etc. at 12 weeks

  • 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 ] [ Designated as safety issue: No ]
    Change from baseline in working memory etc. at 12 weeks


Estimated Enrollment: 83
Study Start Date: November 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seroquel-XR
The subjects At-Risk Mental States will be treated with Quetiapine(Seroquel-XR) from baseline to end of trial.
Drug: Quetiapine(Seroquel-XR) 50~800mg a day
The only ARMS subjects will be given 50~800mg Seroquel-XR once daily for total of 12 weeks.
Other Name: Quetiapine(Seroquel-XR)
Experimental: Schizophrenia Comparator
The subject with schizophrenia will be treated with standard treatment
Drug: Quetiapine(Seroquel-XR) 50~800mg a day
The only ARMS subjects will be given 50~800mg Seroquel-XR once daily for total of 12 weeks.
Other Name: Quetiapine(Seroquel-XR)
No Intervention: Healthy Control Comparator
The subjects will not be required to treat
Drug: Quetiapine(Seroquel-XR) 50~800mg a day
The only ARMS subjects will be given 50~800mg Seroquel-XR once daily for total of 12 weeks.
Other Name: Quetiapine(Seroquel-XR)

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provision of written informed consent
  2. Male and female aged 20 to 35 years
  3. Able to understand and comply with the requirements of the study

    ARMS:

  4. 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
  5. 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 Criteria:

  1. Pregnancy or lactation
  2. 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.
  3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  4. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
  5. 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
  6. 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
  7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
  8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
  9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
  10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  12. Involvement in the planning and conduct of the study
  13. Previous enrolment or randomisation of treatment in the present study.
  14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  15. 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.

  16. An absolute neutrophil count (ANC) of 1.5 folded 109 per liter
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250847

Contacts
Contact: Suk Kyoon An, MD, Ph D. +82 17 349 8275 ansk@yuhs.ac

Locations
Korea, Republic of
Severance Mental Health Hospital Recruiting
Gwangju-si, Korea, Republic of, 464-100
Contact: SuYoung Lee, MD    +82 31 760 9405    LEESUYOUNG@yuhs.ac   
Principal Investigator: Suk Kyoon An, MD, Ph D         
Sub-Investigator: SuYoung Lee, MD         
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Suk Kyoon An, MD, Ph D    +82 17 349 8275    ansk@yuhs.ac   
Principal Investigator: Suk Kyoon An, MD, Ph D         
Sponsors and Collaborators
Severance Hospital
Investigators
Principal Investigator: Suk Kyoon An, MD, Ph D YonSei University Severance Hospital
  More Information

No publications provided

Responsible Party: Suk Kyoon An, Severance Hospital
ClinicalTrials.gov Identifier: NCT01250847     History of Changes
Other Study ID Numbers: ARMS-4001
Study First Received: November 29, 2010
Last Updated: August 18, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Severance Hospital:
ARMS
Ultra High Risk
Quetiapine
Verbal memory

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 26, 2014