A Double-blind, Placebo-controlled Trial of Citicoline add-on Therapy in Patients With a History of Mania or Hypomania and Cocaine Abuse/Dependence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cocaine Use Determined by Urine Analysis
研究概览
简要总结
The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.
详细描述
Forty-four outpatients meeting the inclusion and exclusion criteria were enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation included a medical and psychiatric history, structured diagnostic interview using Diagnostic and Statistical Manual (DSM)-IV criteria, mood assessment with the Inventory of Depressive Symptomatology-Self Report (IDS-SR), Young Mania Rating Scale (YMRS), and cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT). Alternate but equivalent versions of the RAVLT were used to minimize practice effects with repeated administration. Cocaine use was assessed at each biweekly visit with urine drug screens. Citicoline or placebo was given beginning at one tablet (500 mg)/day with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4, and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 18-70 years
- •History of mania or hypomania (bipolar I,II, not otherwise specified (NOS) or cyclothymic disorder or schizoaffective disorder/bipolar type)
- •Early recovery for cocaine abuse/dependence (between 7 days and 12 weeks of enrollment).
- •Any current mood state as indicated by structured diagnostic interview
- •No psychotropic medication changes within 7 days prior to enrollment.
- •English or Spanish speaking
排除标准
- •Pregnant/nursing woman
- •Current or past citicoline therapy
- •Active suicidal or homicidal ideation with plan and intent
- •Dementia, mental retardation or other severe cognitive impairment
- •Severe or life threatening medical condition
研究组 & 干预措施
Citicoline
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
干预措施: Citicoline (Drug)
Placebo
Inactive ingredient matching the active medication in appearance
干预措施: Placebo (Drug)
结局指标
主要结局
Cocaine Use Determined by Urine Analysis
时间窗: Biweekly (visit) urine drug screens
Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks.
次要结局
- Inventory of Depressive Symptomatology Self Report (IDS-SR).(Change in scores between baseline and exit (exit - baseline).)
- Young Mania Rating Scale(YMRS).(Baseline to exit (exit score - baseline score))
- Rey Auditory Verbal Learning Test(RAVLT)(Change in T scores between baseline and exit (exitT score - baseline T score).)
研究者
Sherwood Brown
professor
University of Texas Southwestern Medical Center