Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score
研究概览
简要总结
The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The secondary aim is to generate an estimate of effect size to power a definitive large-scale, multi-site collaborative R01 and to configure the use of the primary and secondary outcome measures in the definitive large-scale study.
详细描述
120 subjects aged 18 and up with Diagnostic and Statistical Manual -IV Generalized Anxiety Disorder and Bipolar Disorder type I or II as identified by extensive clinical interview and the Mini-International Neuropsychiatric Interview (MINI) will be enrolled and randomized. Assignment to each arm will be balanced for BP I vs BP II; male vs female; and with vs without SUD. Potential participants will be recruited by means of Institutional Review Board -approved advertising or from the clinical psychiatric infrastructure.
This study is a randomized, double-blind, placebo-controlled, 8-week comparison of quetiapine sustained-release monotherapy or adjunctive mood stabilizer therapy vs. placebo in the acute treatment of comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. Subjects will be assessed weekly for mood changes and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual-IV diagnosis of bipolar I or II disorder, and currently depressed as confirmed by the MINI-Plus at Screening.
- •Diagnostic and Statistical Manual-IV diagnosis of lifetime GAD;
- •Hamilton Depression Rating Scale -17 items total score ≥ 18;
- •Hamilton Anxiety Rating Scale total score ≥ 18;
- •Be male or female at least 18 year old and not older than 65.
排除标准
- •Pregnancy or breast feeding.
- •Severe medical or neurological problems.
- •Severe personality disorder.
- •Currently suicidal risk judged by physician.
- •Known history of intolerance or hypersensitivity to any of the medications involved in the study.
- •Treatment with quetiapine at any dose in the 6 months prior to randomization.
- •Known lack of response to quetiapine in a dosage of at least 50 mg for 4 weeks at any time, as judged by the investigator.
- •Dependence on opiate, phencyclidine (PCP), and/or barbiturate.
- •Acute mania as determined by a score > 12 on the Young Mania Rating Scale at baseline.
- •Concurrent obsessive compulsive disorder.
- •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 inducers in the 14 days preceding enrollment 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
- •Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •Unstable or inadequately treated medical illness (e.g. diabetes, 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: a. Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) .8.5% b. Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks c. Not under physician care for DM d. Physician responsible for patient's DM care has not indicated that the patient's DM is controlled f. Physician responsible for patient's DM care has not approved the patient's participation in the study g. Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks before randomization h. 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 patient with DM 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.
研究组 & 干预措施
1
Quetiapine XR
干预措施: Quetiapine XR (Drug)
2
Placebo for quetiapine XR
干预措施: Placebo for quetiapine XR (Drug)
结局指标
主要结局
Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score
时间窗: Week 0 - Week 8
A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
次要结局
- Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)(Week 0 - Week 8)
- Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)(Week 0 - Week 8)
- Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score(Week 0 - Week 8)
- Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score(Week 0 - Week 8)
- Change in Hamilton Rating Scale for Anxiety (HAM-A)(Week 0 - Week 8)
研究者
Keming Gao
Director, Mood & Anxiety Clinic
University Hospitals Cleveland Medical Center