EUCTR2004-004909-16-GB进行中（未招募）1 期
An International, Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™, single oral 300 mg or 600 mg dose) and Paroxetine as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 26 up to 52 weeks. - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 660
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Provision of written informed consent before initiation of any study related
- •procedures.
- •2. Male and female patients aged 18 to 65 years, inclusive.
- •3. Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of
- •Mental Disorders, 4th edition (DSM-IV, American Psychiatric Association 1994)
- •criteria for bipolar I disorder or bipolar II disorder, most recent episode depressed
- •(296.50-296.54 and 296.89 respectively) confirmed by the amended version of the
- •Structured Clinical Interview for DSM-IV (SCID).
- •4. HAM-D (17-item) total score of =20 and HAM-D item 1 (depressed mood) score
- •=2 at Visit 1 (Enrolment) and 2 (Randomisation).
- •5. Be able to understand and comply with the requirements of the study, as judged by
- •the investigator.
- •6. Outpatient status at Visit1 (Enrolment) and Visit2 (Randomisation).
- •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
排除标准
- •1. Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is
- •symptomatic or requiring treatment within 6 months of enrolment.
- •2. YMRS total >12 at enrolment or randomisation.
- •3. Patients with more than 8 mood episodes during the past 12 months.
- •4. Patients whose current episode of depression exceeds 12 months or is less than 4
- •weeks from enrolment.
- •5. History of non-response to an adequate treatment (6 weeks) with more than 2
- •classes of antidepressants during their current episode.
- •6. Substance/alcohol dependence or abuse at enrolment (except dependence in full
- •remission (>12 months) and except caffeine and nicotine dependence) as defined by
- •DSM-IV criteria. Patients with a positive urine toxicology screen will be excluded
- •only if they satisfy the DSM-IV criteria for abuse or dependence. However, a
- •single urine toxicology screen for cocaine, heroin or PCP will lead to exclusion.
- •7. Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4
- •enzymes within 2 weeks prior to randomisation or during the randomisation period
- •(see Section 3.7.3, Table 5).
- •8. Use of the following medication:
- •-antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic or other
- •psychoactive drugs within 5 days before randomisation
- •-fluoxetine within 28 days before randomisation
- •-extended release risperidone within 14 days before randomisation
- •-a depot antipsychotic injection within one dosing interval (for the depot) before
- •randomisation
- •-lithium within 7 days before randomisation and/or tapering off started less than
- •14 days before randomisation
- •-irreversible monoamine oxidase inhibitors within 14 days before
- •randomisation.
- •9. Patients who in the investigators opinion will require formalised psychotherapy
- •during the study period, unless psychotherapy has been ongoing for a minimum of 3
- •months prior to randomisation.
- •10. Patients who, in the investigator’s judgment pose a current serious suicidal or
- •homicidal risk, have a HAM-D item 3 score of 3 or greater, or have made a suicide
- •attempt within the past 6 months.
- •11. Pregnancy or lactation. 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, double-barrier method, oral contraceptive, implant, dermal
- •contraception, long-term injectable contraceptive, intrauterine device, or tubal
- •ligation, during the study.
- •12. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •-Unstable DM defined as enrolment HbA1c (or HgA1c) >8.5%.
- •-Admitted to hospital for treatment of DM or DM related illness in past 12
- •-Not under care of physician responsible for patient’s DM care.
- •-Physician responsible for patient’s DM care has not indicated that patie
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