NCT00252226已完成3 期
Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders: An Open Prospective Longitudinal Study of the Effectiveness of Quetiapine Monotherapy in Preventing Relapse and Minimizing Neurocognitive Dysfunction Among Adolescents Manifesting Bipolar Spectrum Disorders
Mood Disorders Center of Ottawa2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2004年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of treated study patients maintained on monotherapy for the duration of the trial compared to the proportion requiring systematic adjunctive medication.
研究概览
简要总结
This is a single center, open prospective study to evaluate the effectiveness of quetiapine monotherapy in the maintenance treatment of adolescent patients with a bipolar spectrum disorder (bipolar I and bipolar II disorders, cyclothymia, and bipolar disorder not otherwise specified [bipolar NOS]) for a minimum of 48 weeks. Patients will be screened (enrolment phase) either when already stabilized or during an acute episode of mania/hypomania or depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent before initiation of any study-related procedures.
- •A lifetime diagnosis of bipolar spectrum disorder: bipolar I and bipolar II disorders, cyclothymia, bipolar NOS, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV).
- •Male or female, between the ages of 12 and 20 years at enrolment.
- •No preventive treatment at least one month prior to enrolment.
- •Female patients of childbearing potential and who are sexually active must be using a reliable method of contraception. Reliable methods of contraception include hormonal contraceptives (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive), double-barrier methods (e.g., condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation.
- •Able to understand and comply with the requirements of the study.
排除标准
- •Known intolerance or lack of response to quetiapine fumarate as judged by the investigator.
- •Pregnancy or lactation. Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
- •History of substance or alcohol dependence within three months of enrolment (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.
- •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, and saquinavir. Should a new drug be started, investigators will consult the pharmacy as this list is not exhaustive.
- •Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
- •Current use of fluvoxamine, nefazodone, or grapefruit juice.
- •Thyroid stimulating hormone (TSH) concentration outside of the normal range.
- •Unstable or inadequately treated medical illness (e.g., diabetes, angina pectoris, hypertension) as judged by the investigator.
- •History of hepatic disease, or elevated hepatic enzymes at entry testing.
- •Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment.
- •Use of an experimental drug within 30 days of enrolment.
- •Previous trials of maintenance therapy.
结局指标
主要结局
Proportion of treated study patients maintained on monotherapy for the duration of the trial compared to the proportion requiring systematic adjunctive medication.
次要结局
- Time to hospitalization
- Time to an episode recurrence (Montgomery-Asberg Depression Rating Scale
- /Young Mania Rating Scale [MADRS/YMRS] > 15)
- Autobiographical Memory Interview (AMI) mean score over treatment
- Clinical Global Impression-Bipolar Disorder (CGI-BP) score during treatment and at study completion
- YMRS total score during treatment and at study completion
- MADRS total score during treatment and at study completion
研究者
研究点 (2)
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