NCT00071253终止4 期
A Randomized, Double-Blind Study of Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 180
- 试验地点
- 30
- 主要终点
- CGI-s
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of continued combination therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness.
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
- Double
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
- •DSM-IV-TR primary diagnosis of Bipolar I Disorder as confirmed by the SCID
- •Outpatient receiving treatment with a combination of Depakote plus olanzapine for their bipolar illness and considered clinically stable (e.g., no more than minimal symptoms, no psychiatric hospitalizations, no increase in intensity of clinical interventions) for the preceding 4 months
- •Identified at Screening a most bothersome side effect listed in the UKU which makes switching to monotherapy desirable
- •MRS total score < 12 on two consecutive ratings, separated by at least 5 days (Screening and Day 1)
- •DSS score < 13 on two consecutive ratings, separated by at least five days (Screening and Day 1)
- •CGI-S score < 3 on two consecutive ratings, separated by at least five days (Screening and Day 1)
- •Serum valproate level > 45 mcg/mL, and a maximum allowable dose of Depakote of 3000 mg/day at Screening
- •Olanzapine dose between 5 and 20 mg/day at Screening
排除标准
- •History of schizophrenia or schizoaffective disorder
- •Axis I (e.g., anxiety disorder) or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- •Has taken antipsychotics, mood stabilizers, or anticonvulsants (unless specifically for seizure control) other than Depakote or olanzapine in the four months prior to randomization. Other psychotropics (e.g., antidepressants, anxiolytics) with the exception of stimulants, that have been used routinely to maintain stability in the preceding four months may be continued, but not increased or decreased
- •Has first manic episode after age 60
- •Has ever taken clozapine
- •Has received depot neuroleptic medication within six months of randomization
- •Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
- •History of active alcohol or substance abuse/dependence within 90 days prior to Screening
- •Known history of non-response to either Depakote or olanzapine monotherapy for the treatment of bipolar disorder
结局指标
主要结局
CGI-s
CGI-i
MRS
DSS
SADS-C
次要结局
未报告次要终点
研究者
研究点 (30)
Loading locations...
相似试验
撤回
3 期
An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient InsomniaTransient InsomniaNCT03338764Sequential Medicine Ltd
Unknown
3 期
Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT02089126LG Life Sciences230
已完成
2 期
Intravenous Tapentadol in Post-Bunionectomy PainBunionPainNCT01435577Grünenthal GmbH177
已完成
2 期
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT03662542Janssen Research & Development, LLC214
已完成
2 期
Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)Rheumatoid ArthritisNCT00664521Merck KGaA, Darmstadt, Germany27