Algorithm Guided Treatment Strategies for Bipolar Depression
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The change of HAM-D total score only for the phase I
研究概览
简要总结
The purpose of the AGTs-BD study is to compare the treatment outcome and safety profiles between different mood stabilizers combination treatments in the patients with bipolar disorders, currently suffered from depression episode.
详细描述
The AGTs-BD study is a randomized, open-label, rater-blind, multicenter study, which including an 8-week acute treatment (Phase I), followed by a 24-week recurrence prevention treatment (Phase II), and a 24-week relapse prevention treatment (Phase III). Patients initially enter an up to 4 weeks screening phase to confirm the randomization to whom met DSM-IV criteria of bipolar I or II disorder, currently depressed with Hamilton Depression Rating Scale-17 items (HAM-D) total score ≥17. The protocol was approved by the each sites' appropriate institutional review boards and ethics committees. After screening, patients were randomly allocated to one of three groups: (1) lithium monotherapy; (2) lithium plus quetiapine; (3) lithium plus a Traditional Chinese Medicine (TCM) named as Shuganjieyu capsule (SGJY, St. John's wort and acanthopanax senticosus combination). After phase I, patients who met stable remission, defined as HAM-D total score ≤7 and Young Mania Rating Scale (YMRS) total score ≤10 in two consecutive visit at least 4 weeks, were qualified into phase II and III. Patients remained on the allocated treatment for up to 48 weeks or until treatment failure. The difference between phase II and phase III was that treatment dose could be decreased (within the study ranges) if side-effects became troublesome in phase III, but not for phase II. All patients will be provided with free care (3 visits) by the investigators, for a period of up to 3 months after the end of the study, in order to help them make the transition into routine clinical care.
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
- Single (Outcomes Assessor)
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
- •Age from 18 to 65 years old;
- •Han Chinese;
- •Outpatient and inpatient patients;
- •Patients met DSM-IV criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
- •HAM-D total score≥17, HAM-D item 1 (depressed mood) score≥2, and YMRS total score≤10 at baseline;
- •Written informed consent was given;
- •Junior high school education and above, with enough audio-visual ability to accomplish the visits;
- •Normally resident in one country and had a residential address, able to follow-up.
排除标准
- •Bipolar disorder rapid cycling or mixed episode;
- •Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
- •Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
- •Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
- •Known history of intolerance or hypersensitivity to any of the medications involved in the study, including lithium, quetiapine and SGJY capsule;
- •Female patients who were pregnant, planning to be pregnant or breast feeding;
- •Severe medical or neurological problems.
研究组 & 干预措施
lithium combined with TCM
TCM (Traditional Chinese Medicine), Shuganjieyu capsule adjunctive to lithium therapy.
干预措施: Lithium (Drug)
lithium combined with TCM
TCM (Traditional Chinese Medicine), Shuganjieyu capsule adjunctive to lithium therapy.
干预措施: Shuganjieyu capsule (Drug)
Lithium monotherpy
Lithium monotherapy
干预措施: Lithium (Drug)
Lithium combined with SGAs
SGAs (Second Generation Antipsychotics), quetiapine adjunctive to lithium therapy
干预措施: Lithium (Drug)
Lithium combined with SGAs
SGAs (Second Generation Antipsychotics), quetiapine adjunctive to lithium therapy
干预措施: Quetiapine (Drug)
结局指标
主要结局
The change of HAM-D total score only for the phase I
时间窗: baseline and 8 weeks
Time to new intervention for an emerging mood episode
时间窗: up to 48 weeks
Time to new intervention for an emerging mood episode is only for Phase II and Phase III, including drug treatment (commencement of a new drug, increase in dose of concurrent drug, restarting of a discontinued drug, or increasing the investigational drug dose in response to an emergent mood episode) or admission to hospital.
次要结局
- Mean changes from baseline to EOS in 6-item Quality of Life scale (QOL-6)(8 weeks for phase I, up to 48 weeks for phase II and III)
- Young Mania Rating Scale (YMRS) total score ≤10(8 weeks for phase I, up to 48 weeks for phase II and III)
- HAM-D total score ≤7(8 weeks for phase I, up to 48 weeks for phase II and III)
- Mean changes from baseline to EOS in HAM-D total score ≥50%(8 weeks for phase I, up to 48 weeks for phase II and III)
- Mean changes from baseline to EOS in 16-item Quick Inventory of Depressive Symptomatology-Patient Self-Report (QIDS16-SR)(8 weeks for phase I, up to 48 weeks for phase II and III)
- Mean changes from baseline to EOS in Clinical Global Impression scale of Bipolar Disorder-Severity (CGI-BP-S)(8 weeks for phase I, up to 48 weeks for phase II and III)
- Mean changes from baseline to EOS in Sheehan Disability Scale (SDS)(8 weeks for phase I, up to 48 weeks for phase II and III)
研究者
Yiru FANG M.D., Ph.D.
M.D., Ph.D., Professor of Psychiatry
Shanghai Mental Health Center