A Comparison of Medication Augmentation and Problem Solving Therapy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hamilton Psychiatric Rating Scale for Depression
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication.
详细描述
Depression is common in older adults, and antidepressant medication is only effective in about 60% of patients seeking treatment. The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication. If patients have not remitted at the end of the 6 week aripiprazole trial, the aripiprazole will be stopped and they will be started on bupropion for the remaining 6 weeks of the study. Both aripiprazole augmentation and bupropion augmentation in depressed older adults have been approved by the FDA. No study has compared the effectiveness of PST and medication augmentation strategies for depressed older adults who are non-responders to an adequate trial of antidepressant medication in the current episode of their depression.
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
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 50-90, inclusive
- •Current diagnosis of major depressive disorder or dysthymia
- •Treatment with either citalopram 30/mg or duloxetine 60 mg/day (6 weeks total, with at least three weeks of treatment at that dose)
- •Hamilton Rating Scale for Depression (HRSD) >= 14
- •Willing and able to complete NP testing
- •Willing and able to complete medical exam, EKG, blood tests, and urine screen
- •Willing and able to give consent
排除标准
- •Meets criteria for psychotic depression
- •MMSE score <24
- •Bipolar disorder, psychotic disorder, or OCD
- •History of alcohol or drug dependence (excluding nicotine) within past six months
- •Suicide attempt within past six months or HRSD item 2 score > 2
- •Diagnosis of probable Alzheimer's disease
- •Diagnosis of probable vascular dementia
- •Acute, severe, or unstable medical illness
- •Patients in psychotherapy
- •Diagnosis of Parkinson's Disease
- •Blood glucose >200 and/or total cholesterol >250
研究组 & 干预措施
Medication Augmentation
Medication augmentation with aripiprazole (Abilify) starting at 5mg/day, and increasing weekly in 5mg increments to a maximum of 15mg (10mg/day is the target dose). Under conditions of nonresponse after 6 weeks, aripiprazole will be switched for bupropion (Wellbutrin), starting at 150mg, and possibly increasing to 300mg after 2 weeks.
干预措施: Aripiprazole (Drug)
Medication Augmentation
Medication augmentation with aripiprazole (Abilify) starting at 5mg/day, and increasing weekly in 5mg increments to a maximum of 15mg (10mg/day is the target dose). Under conditions of nonresponse after 6 weeks, aripiprazole will be switched for bupropion (Wellbutrin), starting at 150mg, and possibly increasing to 300mg after 2 weeks.
干预措施: Bupropion (Drug)
Problem Solving Therapy
Treatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist.
干预措施: Problem Solving Therapy (Behavioral)
结局指标
主要结局
Hamilton Psychiatric Rating Scale for Depression
时间窗: 12 weeks
The Hamilton Depression Rating Scale (HAM-D) is used as a way of determining a patient's level of depression before, during, and after treatment. The scoring is based on the first 17 list items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
次要结局
- Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test(1 Day)
研究者
Bret Rutherford
Associate Professor of Clinical Psychiatry
New York State Psychiatric Institute