Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 5
- 主要终点
- Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 Years or older
- •BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P)
- •HAM-D score > 18 (GRID-HAM-D 24-item version)
- •Availability of an Informant is encouraged but not required for study participation
排除标准
- •Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder
- •Contraindication to lamotrigine (Physician interview, medical assessment)
- •Documented history of intolerance to lamotrigine
- •Patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine
- •Active substance dependence (SCID-I/P) or substance-related safety issues or PI concerns
- •Mood Disorder Due to a General Medical Condition or Treatment (Physician interview)
- •Rapid cycling (Physician interview): As defined in DSM-IV: At least 4 episodes of mood disturbance in the previous 12 months that meet criteria for a Major Depressive, Manic, Mixed or Hypomanic Episode. Episodes are distinguished either by partial or full remission for at least 2 months or by a switch to an episode of opposite polarity
- •Dementia (by DSM-IV or brain degenerative diseases; Physician interview);
- •Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English)
- •Clinically significant sensory impairment (i.e., cannot see well enough to read consent or visually-presented material; cannot hear well enough to cooperate with interview; Physician interview)
- •Recent history of cardiovascular, peripheral vascular events or stroke
- •High risk for suicide (e.g., active SI or current intent or plan)
- •Inpatient status
研究组 & 干预措施
Open-Label Lamotrigine Treatment
干预措施: Lamotrigine regular tablet formulation (Drug)
Open-Label Lamotrigine Treatment
干预措施: Lamotrigine novel formulation (Drug)
结局指标
主要结局
Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: 12 weeks
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
次要结局
- Number of Participants Who Fell at Least Once During the Study(12 weeks)
- Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)(12 weeks)
- Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP(12 weeks)
- Change in Body Weight From Baseline(12 weeks)
- Number of Participants Who Had a Fall That Required Medical Attention(12 weeks)
- Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)(12 weeks)
- Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine(12 weeks)
- Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)(12 weeks)
- Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)(12 weeks)
- Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)(12 weeks)
- Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)(12 weeks)
研究者
Martha Sajatovic
Professor of Psychiatry
University Hospitals Cleveland Medical Center