A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching any Antipsychotic Treatment to Sustained-release Quetiapine Fumarate (SEROQUEL) in Patients with Schizophrenia

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2004-000913-21-LV
• Date of registration: 22/11/2005
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca R&D Södertälje
• Public title: A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching any Antipsychotic Treatment to Sustained-release Quetiapine Fumarate (SEROQUEL) in Patients with Schizophrenia
• Scientific title: A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching any Antipsychotic Treatment to Sustained-release Quetiapine Fumarate (SEROQUEL) in Patients with Schizophrenia
• Date of first enrolment: 27/12/2005
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000913-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Estonia, Finland, Hungary, Latvia

Key inclusion & exclusion criteria

Inclusion criteria:
For inclusion in the study patients must fulfill all of the following criteria:

1. Provision of written informed consent. Patients who are deemed incapable of providing informed consent may be enrolled if the written informed consent has been obtained from the patients Legally Authorised Representative. Inclusion in the genetic part of the study is under provision of a written informed consent separate from the main study.
2. Female and male age more than or equal to 18 and less than or equal to 65 years
3. Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for any of the following:
Schizophrenia DSM-IV
catatonic 295.20
disorganised 295.10
paranoid 295.30
undifferentiated 295.90
4. Patients who in their own and/or in the Investigator’s opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability.
5. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
6. Be able to understand and comply with the requirements of the study, as judged by the Investigator.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation.
2. Substance abuse or dependence as defined by DSM-IV and not in full remission. A urine drug screen test will be performed. The Investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
3. Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids as judged by the Investigator.
4. Patients who, in the opinion of the Investigator, pose an imminent risk of suicide or a danger to self or others.
5. History of non-compliance as judged by the Investigator.
6. Evidence of clinically relevant disease, (eg, renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome [AIDS] or cancer) or a clinical finding that is unstable or that, in the opinion of the Investigator, would be negatively affected by the investigational product or that would affect the investigational product
7. Clinically significant deviation from the reference range in clinical laboratory test results at enrolment as judged by the Investigator.
8. ECG considered to show cardiac abnormality at enrolment as determined by a central reader cardiologist and confirmed by Investigator as clinically significant.
9. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- unstable DM defined as enrolment glycosylated Hb >8.5%
- admitted to hospital for treatment of DM or DM related illness in the past 12 weeks
- not under care of physician responsible for patient’s DM care
- 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 hypoglycemic drug(s) and/or diet for the 4 weeks prior to enrolment (Visit 1). 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% 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.
10. A thyroid-stimulating hormone (TSH) concentration higher than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the patient is being treated for hypothyroidism.
11. Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before day of switch (Visit 2).
12. Known intolerance, or lack of response to treatment with quetiapine IR or treatment with quetiapine IR within 4 weeks prior to enrolment.
13. Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrolment.
14. Patients who have started treatment within 4 weeks prior to enrolment with potent cytochrome 3A4 inducers or inhibitors that could potentially affect the metabolism of quetiapine (eg, inducers: phenytoin, carbamazepine, pentobarbital, rifampin, rifabutin, glucocorticoids, thioridazine, St. John's Wort. inhibitors: ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, nefa

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Product Name: Seroquel® SR (Quetiapine Fumarate)
Product Code: ZD5077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine Fumarate SR
CAS Number: 111974-72-2
Current Sponsor code: ZD5077
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Product Name: Seroquel® SR (Quetiapine Fumarate)
Product Code: ZD5077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine Fumarate SR
CAS Number: 111974-72-2
Current Sponsor code: ZD5077
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Main Objective: The primary objective is to document the clinical benefit of quetiapine SR after switching from other ongoing antipsychotic treatment, regardless of the reason for the switch.

Primary end point(s): The proportion of patients who at Visit 7 (Week 12) have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability using the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the principles outlined in Clinical Global Impression item 3 (CGI item 3). Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB.

Secondary Objective: The secondary objective is to document improved tolerability, safety or efficacy after switching to quetiapine SR from other ongoing antipsychotic treatment, regardless of the reason for switch.

Secondary ID(s)

2004-000913-21-FI

D1444C00147