Open Label Prophylaxis Study of Lithium Plus Extended- Release Carbamazepine (Equetro®) Combination for Rapid Cycling Bipolar Disorder
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary efficacy measure will be the time to relapse. Relapse will determined by; need for additional pharmacotherapy, hospitalization for an affective episode, increase of >/= 50% in HAM-D and YMRS scores.
研究概览
简要总结
This is an open label design using Lithium plus extended release carbamazepine (Equetro) in combination for 6 months. Rapid cycling bipolar disorder is frequently treatment refractory and associated with repeated hospitalizations and complications. The results of this study will offer a promising approach to treat this complex disorder. The primary efficacy measure will be the time to relapse. Relapse will determined by the investigator based on the following: Need for additional pharmacotherapy for mood-related symptoms, hospitalization for an mood episode, increase of more than 50% in HAM-D and YMRS scores from the baseline visit.
详细描述
Open label Design with Lithium plus Extended release carbamazepine combination for 6 months. Extended release carbamazepine at doses of 1600 mg/day will be utilized. Lithium dosage will be adjusted to maintain therapeutic blood levels.
Patient Population: N = 20.
Primary and Secondary Efficacy Endpoints:
The primary efficacy measure will be the time to relapse. Relapse will determined by the investigator based on the following
- Need for additional pharmacotherapy for affective symptoms
- Hospitalization for an affective episode
- Increase of more than 50% in HAM-D and YMRS scores from baseline
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects, 19 years and older with DSM-IV defined Bipolar Disorder with a history of the rapid cycling within the past 12 months.
- •Subjects may be either in a manic, mixed or depressive phase at time of study entry.
- •Subjects must be on lithium therapy for 6 months or longer. Stable lithium therapy will be defined as: No changes in lithium dosage for at least 2 weeks prior to study entry and a therapeutic lithium level (0.6 to 1.2 mEq) prior to study entry.
排除标准
- •Subjects with a lifetime history of Schizophrenia or Schizoaffective Disorder
- •If patients are on thyroid replacement therapy they have to on stable doses for the past 3 months at study enrollment.
- •Presence of active suicide ideations or score of > 3 on the suicide subscale of the 17 - item HAM-D.
- •Current substance dependence (excluding nicotine) defined as no dependence criteria for 30 days prior to study enrollment
- •Subjects with a history of non-response to carbamazepine or lithium
- •Subjects who are pregnant or planning to become pregnant
- •Subjects with a history of allergic/idiosyncratic reaction or intolerability to carbamazepine or lithium.
研究组 & 干预措施
1
Treatment with lithium and extended release carbamazepine
干预措施: Lithium Plus Extended- Release Carbamazepine (Drug)
结局指标
主要结局
The primary efficacy measure will be the time to relapse. Relapse will determined by; need for additional pharmacotherapy, hospitalization for an affective episode, increase of >/= 50% in HAM-D and YMRS scores.
时间窗: Patients will be seen weekly during preliminary phase and biweekly during the open label phase
次要结局
- The differences in the frequency of affective episodes in the 6-month prior to the treatment with ERC-CBZ and 6 months after treatment initiation will also be measured. Secondary efficacy measures will include; changes in the 17- Item Hamilton Depression(Patients will be seen weekly during the preliminary phase and biweekly during the open label phase)